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The latest medical device supervision and management regulations focus on key words innovation, inspection, clinical, registrant

The latest medical device supervision and management regulations focus on key words innovation, inspection, clinical, registrant

  • Categories:Industry News
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  • Origin:奥咨达
  • Time of issue:2021-03-17
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(Summary description)The "Regulations on the Supervision and Administration of Medical Devices" have been revised and adopted at the 119th executive meeting of the State Council on December 21, 2020. They are hereby promulgated and shall come into force on June 1, 2021.

The latest medical device supervision and management regulations focus on key words innovation, inspection, clinical, registrant

(Summary description)The "Regulations on the Supervision and Administration of Medical Devices" have been revised and adopted at the 119th executive meeting of the State Council on December 21, 2020. They are hereby promulgated and shall come into force on June 1, 2021.

  • Categories:Industry News
  • Author:
  • Origin:奥咨达
  • Time of issue:2021-03-17
  • Views:0
Information

The "Regulations on the Supervision and Administration of Medical Devices" have been revised and adopted at the 119th executive meeting of the State Council on December 21, 2020. They are hereby promulgated and shall come into force on June 1, 2021.

   February 9, 2021

   Medical Device Supervision and Administration Regulations

(Announced by Order No. 276 of the State Council of the People's Republic of China on January 4, 2000, revised and adopted at the 39th executive meeting of the State Council on February 12, 2014 》Revised and adopted at the 119th executive meeting of the State Council on December 21, 2020)

   Chapter 1 General Provisions

   Article 1 In order to ensure the safety and effectiveness of medical devices, protect human health and life safety, and promote the development of the medical device industry, these regulations are formulated.

   Article 2 These Regulations shall apply to the activities of research, development, production, operation, use and supervision of medical devices within the territory of the People's Republic of China.

   Article 3 The drug regulatory department of the State Council is responsible for the supervision and management of medical devices nationwide.

   The relevant departments of the State Council are responsible for the supervision and management of medical devices within their respective responsibilities.

Article 4 The local people's government at or above the county level shall strengthen the leadership of the medical device supervision and management work in its administrative area, organize and coordinate the medical device supervision and management work and emergency response work within the administrative area, and strengthen the construction of medical device supervision and management capabilities. Provide guarantee for the safety of medical equipment.

  The department responsible for drug supervision and management of the local people's government at or above the county level is responsible for the supervision and management of medical devices in the administrative region. Relevant departments of local people's governments at or above the county level are responsible for the supervision and management of medical devices within their respective responsibilities.

  Article 5 The supervision and management of medical devices shall follow the principles of risk management, full-process control, scientific supervision, and social co-governance.

   Article 6 The state implements classified management of medical devices according to the degree of risk.

   The first category is medical devices that have a low degree of risk, and the implementation of routine management can ensure their safety and effectiveness.

   The second category is medical devices that have moderate risks and require strict control and management to ensure their safety and effectiveness.

   The third category is medical devices that have higher risks and require special measures to strictly control and manage them to ensure their safety and effectiveness.

  Evaluating the degree of risk of medical devices should consider factors such as the intended purpose, structural features, and methods of use of the medical device.

   The State Council's drug regulatory authority is responsible for formulating the classification rules and classification catalogs of medical devices, and according to the production, operation and use of medical devices, timely analyze and evaluate the risk changes of medical devices, and adjust the classification rules and classification catalogs. To formulate and adjust classification rules and classification catalogs, the opinions of medical device registrants, recorders, production and operation enterprises, user units, and industry organizations shall be fully listened to, and the practice of international medical device classification shall be referred to. The classification rules and classification catalogs of medical devices shall be published to the public.

   Article 7 Medical device products shall comply with the mandatory national standards for medical devices. Where there is no mandatory national standard, they shall comply with the mandatory industry standards for medical devices.

  Article 8 The state formulates plans and policies for the medical device industry, incorporates medical device innovation into the development focus, prioritizes the review and approval of innovative medical devices, supports the clinical promotion and use of innovative medical devices, and promotes the high-quality development of the medical device industry. The drug regulatory department of the State Council shall cooperate with the relevant departments of the State Council to implement the national medical device industry planning and guiding policies.

  Article 9 The state improves the medical device innovation system, supports basic research and applied research of medical devices, promotes the promotion and application of new medical device technologies, and provides support in scientific and technological projects, financing, credit, bidding and procurement, and medical insurance. Support enterprises to establish or jointly establish research and development institutions, encourage enterprises to cooperate with universities, scientific research institutes, medical institutions, etc. to carry out research and innovation of medical devices, strengthen intellectual property protection of medical devices, and improve independent innovation capabilities of medical devices.

  Article 10 The state strengthens the construction of informatization of medical device supervision and management, improves the level of online government services, and facilitates the administrative licensing and filing of medical devices.

   Article 11 Medical device industry organizations shall strengthen industry self-discipline, promote the establishment of a credit system, urge enterprises to carry out production and operation activities in accordance with the law, and guide enterprises to be honest and trustworthy.

   Article 12 Units and individuals that have made outstanding contributions to the research and innovation of medical devices shall be commended and rewarded in accordance with relevant national regulations.

   Chapter 2 Medical Device Product Registration and Filing

  Article 13 The first category medical devices are subject to product registration management, and the second and third categories of medical devices are subject to product registration management.

  Medical device registrants and recorders shall strengthen the quality management of the entire life cycle of medical devices, and shall be responsible for the safety and effectiveness of medical devices in the entire process of development, production, operation, and use.

  Article 14 For registration of Class I medical device products and application for Class II and Class III medical device product registration, the following materials shall be submitted:

   (1) Product risk analysis data;

   (2) Product technical requirements;

  (3) Product inspection report;

   (four) clinical evaluation data;

  (5) Product manual and label samples;

  (6) Quality management system documents related to product development and production;

  (7) Other materials needed to prove that the product is safe and effective.

   The product inspection report shall comply with the requirements of the State Council’s drug regulatory authority. It may be a self-inspection report of the medical device registration applicant or filing person, or an inspection report issued by a qualified medical device inspection agency.

   Those who meet the requirements of Article 24 of these Regulations that are exempt from clinical evaluation may be exempt from submitting clinical evaluation materials.

   Medical device registration applicants and recorders shall ensure that the submitted materials are legal, true, accurate, complete and traceable.

   Article 15 For the filing of Class I medical device products, the filing person shall submit the filing materials to the department responsible for drug supervision and management of the municipal people's government at the districted level.

For overseas recorders who export Class I medical devices to the territory of my country, their designated domestic enterprise legal person shall submit the record materials and certification documents of the competent authority of the country (region) where the recorder is located to approve the sale of the medical device to the drug regulatory authority of the State Council. . Innovative medical devices that have not been listed overseas may not be required to submit certification documents that the competent authority of the country (region) where the recorder is located allows the medical device to be marketed.

   The filing person will complete the filing after submitting the filing materials that meet the requirements of these regulations to the department responsible for drug supervision and management. The department responsible for drug supervision and administration shall, within 5 working days from the date of receipt of the filing materials, announce the filing-related information to the public through the online government service platform of the drug supervision and administration department of the State Council.

   If there is a change in the matters stated in the filing materials, the filing shall be changed to the original filing department.

   Article 16 To apply for the registration of the second category of medical device products, the registration applicant shall submit the registration application materials to the drug regulatory department of the people's government of the province, autonomous region, or municipality where it is located. To apply for the registration of Class III medical device products, the registration applicant shall submit the registration application materials to the drug regulatory authority of the State Council.

For overseas registration applicants who export Class II and Class III medical devices to the territory of my country, the domestic enterprise legal person designated by them shall submit the registration application materials to the drug regulatory authority of the State Council and the competent authority of the country (region) where the registration applicant is located shall approve the application. Documents to prove that the medical device is on the market. Innovative medical devices that have not been listed overseas may not be required to submit a certification document that the competent authority of the country (region) where the registration applicant is located allows the medical device to be marketed for sale.

  The State Council's drug regulatory authority shall make provisions on the procedures and requirements for medical device registration and review, and strengthen the supervision and guidance of the drug regulatory authorities of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government.

   Article 17 The drug regulatory authority that accepts registration applications shall review the safety and effectiveness of medical devices, as well as the registration applicant's ability to ensure the safety and effective quality management of medical devices.

   The drug regulatory department that accepts the registration application shall forward the registration application materials to the technical review agency within 3 working days from the date of acceptance of the registration application. The technical review agency shall, after completing the technical review, submit the review comments to the drug regulatory authority that accepts the registration application as the basis for review and approval.

   When the drug regulatory authority accepting the registration application considers it necessary to check the quality management system when organizing the technical review of the medical device, it shall organize the quality management system verification.

   Article 18 The drug regulatory authority that accepts the registration application shall make a decision within 20 working days from the date of receipt of the review comments. For those that meet the conditions, the registration is approved and a medical device registration certificate is issued; for those that do not meet the conditions, the registration is not approved and the reasons are given in writing.

  The drug regulatory authority that accepts the registration application shall, within 5 working days from the date of approval of the registration of the medical device, announce the registration-related information to the public through the online government service platform of the drug regulatory authority of the State Council.

Article 19 For medical devices that are urgently needed for the treatment of rare diseases, serious life-threatening diseases without effective treatment, and response to public health incidents, the drug regulatory authority that accepts the registration application may make a conditional approval decision, and Relevant matters are stated in the medical device registration certificate.

In the event of a particularly major public health emergency or other emergencies that seriously threaten public health, the health authority of the State Council shall make recommendations for the emergency use of medical devices according to the needs of prevention and control of the incident. Emergency use within the scope and time limit.

Article 20 Medical device registrants and filing parties shall perform the following obligations: (1) Establish a quality management system suitable for the product and maintain effective operation; (2) Formulate a post-market research and risk control plan and ensure effective implementation; ( 3) Carry out adverse event monitoring and re-evaluation in accordance with the law; (4) Establish and implement a product traceability and recall system; (5) Other obligations stipulated by the drug regulatory department of the State Council.

  The domestic enterprise legal person designated by the overseas medical device registrant and filing party shall assist the registrant and filing party in fulfilling the obligations stipulated in the preceding paragraph.

Article 21 For registered medical device products of Class II and Class III, the design, raw materials, production process, scope of application, method of use, etc. have undergone substantial changes, which may affect the safety and effectiveness of the medical device, registration Persons should apply to the original registration department to go through the formalities for alteration of registration; if other changes occur, they should be filed or reported in accordance with the regulations of the drug regulatory department under the State Council.

   Article 22 The validity period of the medical device registration certificate is 5 years. If the registration needs to be renewed after the expiration of the validity period, an application for renewal of the registration shall be submitted to the original registration department 6 months before the expiration of the validity period.

   Except for the circumstances specified in the third paragraph of this article, the drug regulatory authority that receives an application for renewal shall make a decision to approve the renewal before the expiration of the medical device registration certificate. If no decision is made within the time limit, it shall be deemed that the renewal is approved.

  In any of the following circumstances, the registration shall not be renewed:

   (1) Failure to file an application for renewal of registration within the prescribed time limit;

  (2) The mandatory standards for medical devices have been revised, and the medical devices applying for renewal of registration cannot meet the new requirements;

   (3) Conditionally approved medical devices fail to complete the items specified in the medical device registration certificate within the prescribed time limit.

Article 23 For newly developed medical devices that have not been included in the classification catalogue, the applicant may directly apply for product registration in accordance with the regulations on the third category of medical device product registration, or they may determine the product category according to the classification rules and apply to the State Council. After the drug regulatory authority applies for category confirmation, it applies for product registration or product filing in accordance with the provisions of these regulations.

   For directly applying for the registration of Class III medical device products, the drug regulatory department of the State Council shall determine the category according to the degree of risk, and timely include the registered medical devices into the classification catalog. If the application category is confirmed, the drug regulatory department of the State Council shall determine the category of the medical device and notify the applicant within 20 working days from the date of acceptance of the application.

   Article 24 The registration and filing of medical device products shall be subject to clinical evaluation; however, one of the following conditions may be exempt from clinical evaluation:

  (1) The working mechanism is clear, the design is finalized, the production process is mature, the medical devices of the same variety that have been marketed have been clinically used for many years, and there is no record of serious adverse events, and the conventional use is not changed;

   (2) Other non-clinical evaluations that can prove that the medical device is safe and effective.

   The drug regulatory department of the State Council shall formulate guidelines for clinical evaluation of medical devices.

Article 25 The clinical evaluation of medical devices can be carried out according to the product characteristics, clinical risks, existing clinical data, etc., through clinical trials, or through analysis and evaluation of the clinical literature and clinical data of the same variety of medical devices to prove the medical treatment. The equipment is safe and effective.

  In accordance with the regulations of the State Council's drug regulatory authority, when conducting clinical evaluation of medical devices, if the existing clinical literature and clinical data are insufficient to confirm the product safety and effectiveness of medical devices, clinical trials should be carried out.

Article 26 The clinical trials of medical devices shall be carried out in clinical trial institutions with corresponding conditions in accordance with the requirements of the quality management standards for medical device clinical trials, and shall be reported to the people’s government of the province, autonomous region, and municipality where the clinical trial sponsor is located. Departmental filing. The drug supervision and administration department that accepts the clinical trial filing shall notify the drug supervision and administration department and the health authority at the same level where the clinical trial institution is located.

   Medical device clinical trial institutions implement record management. The conditions that a medical device clinical trial institution should have, as well as the filing management measures and clinical trial quality management specifications, shall be formulated and announced by the drug regulatory authority of the State Council in conjunction with the health authority of the State Council.

  The state supports medical institutions to carry out clinical trials, incorporates the evaluation of clinical trial conditions and capabilities into the level review of medical institutions, and encourages medical institutions to carry out clinical trials of innovative medical devices.

   Article 27 Clinical trials of Class III medical devices that have a higher risk to humans shall be approved by the drug regulatory department of the State Council. When examining and approving clinical trials, the drug regulatory authority under the State Council shall conduct a comprehensive analysis of the equipment and professionals of the institution that intends to undertake the clinical trials of medical devices, the risk level of the medical devices, the implementation plan of the clinical trials, and the comparative analysis report of clinical benefits and risks, etc. , And make a decision and notify the clinical trial sponsor within 60 working days from the date of acceptance of the application. Failure to notify within the time limit shall be deemed as consent. If a clinical trial is approved, it shall be notified to the drug regulatory department and the health authority of the people's government of the province, autonomous region, or municipality where the clinical trial institution is located.

   The catalogue of Class III medical devices with higher risks to humans in clinical trials shall be formulated, adjusted and published by the drug regulatory authority of the State Council.

  

Article 28 When conducting clinical trials of medical devices, an ethical review shall be carried out in accordance with regulations, the subjects shall be informed of the details of the trial purpose, use and possible risks, and written informed consent shall be obtained from the subjects; A person with civil capacity or a person with limited civil capacity shall obtain the written informed consent of his guardian in accordance with the law.

   To carry out clinical trials, the subjects shall not be charged in any form for fees related to clinical trials.

Article 29 For medical devices that are undergoing clinical trials for the treatment of severely life-threatening diseases that have no effective treatment methods, medical observations may benefit patients. After ethical review and informed consent, medical devices can be used for medical treatment. The device clinical trial institution is free for other patients with the same condition, and its safety data can be used for medical device registration applications.

   Chapter 3 Medical Device Production

   Article 30 To engage in medical device production activities, the following conditions shall be met:

   (1) Have production sites, environmental conditions, production equipment and professional and technical personnel suitable for the medical devices produced;

  (2) Have institutions or full-time inspectors and inspection equipment that can conduct quality inspections on the medical devices produced;

   (3) Have a management system to ensure the quality of medical devices;

   (4) Have after-sales service capabilities that are compatible with the medical devices produced;

  (5) Meet the requirements of product development and production process documents.

Article 31 Those engaged in the production of Class I medical devices shall file with the department responsible for drug supervision and administration of the municipal people’s government at the districted level, and complete the filing after submitting the relevant materials that meet the conditions specified in Article 30 of these regulations. .

  Medical device recorders who produce Class I medical devices on their own may submit relevant materials that meet the conditions specified in Article 30 of these Regulations at the time of product filing in accordance with Article 15 of these Regulations to complete the production record.

Article 32 Those engaged in the production of Class II and Class III medical devices shall apply to the drug regulatory authority of the local province, autonomous region, or municipality directly under the Central Government for a production license and submit relevant materials that meet the conditions specified in Article 30 of these Regulations. And the registration certificate of the medical device produced.

   The drug regulatory authority that accepts the application for production license shall review the application materials, conduct verification in accordance with the requirements of the medical device production quality management regulations formulated by the drug regulatory authority of the State Council, and make a decision within 20 working days from the date of accepting the application. For those that meet the prescribed conditions, the license shall be granted and a medical device production license shall be issued; for those that do not meet the prescribed conditions, the license shall not be granted and the reasons shall be stated in writing.

   The medical device production license is valid for 5 years. If the validity period expires and needs to be renewed, the renewal procedures shall be handled in accordance with the legal provisions of the relevant administrative license.

Article 33 The medical device production quality management norms shall address matters that affect the safety and effectiveness of medical devices, such as the design and development of medical devices, production equipment conditions, raw material procurement, production process control, product release, and enterprise organization and staffing. Clearly stipulate.

   Article 34 Medical device registrants and filing persons may produce medical devices by themselves, or they may entrust enterprises that meet the requirements of these regulations and have corresponding conditions to produce medical devices.

  In the case of entrusted production of medical devices, the medical device registrant and recorder shall be responsible for the quality of the entrusted production of medical devices, and strengthen the management of the production activities of the entrusted production enterprises to ensure that they are produced in accordance with statutory requirements. The medical device registrant and recorder shall sign a commission agreement with the entrusted manufacturing enterprise to clarify the rights, obligations and responsibilities of both parties. The entrusted production enterprise shall organize production in accordance with laws and regulations, medical device production quality management norms, mandatory standards, product technical requirements and entrusted agreements, be responsible for the production activities, and accept the supervision of the entrusting party.

   High-risk implantable medical devices shall not be commissioned for production. The specific catalogue shall be formulated, adjusted and announced by the drug regulatory department of the State Council.

Article 35 Medical device registrants, recorders, and entrusted manufacturers shall establish and improve a quality management system compatible with the medical devices produced and ensure their effective operation in accordance with the medical device production quality management regulations; strictly follow the registered or record The technical requirements of the products are organized to ensure that the medical devices that leave the factory meet the mandatory standards and the technical requirements of the registered or filed products.

   Medical device registrants, recorders, and entrusted manufacturers shall conduct self-inspection on the operation of the quality management system on a regular basis, and submit self-inspection reports in accordance with the regulations of the drug regulatory department of the State Council.

Article 36 If the production conditions of medical devices change and no longer meet the requirements of the medical device quality management system, the medical device registrant, recorder, and entrusted manufacturer shall immediately take corrective measures; if it may affect the safety and effectiveness of the medical device, The production activities shall be stopped immediately and a report shall be made to the original production license or production filing department.

   Article 37 Medical devices shall use common names. The generic name shall comply with the medical device naming rules formulated by the drug regulatory authority under the State Council.

   Article 38 The state shall implement a unique identification system for medical devices step by step according to the category of medical device products to realize the traceability of medical devices. The specific measures shall be formulated by the drug regulatory department of the State Council in conjunction with relevant departments of the State Council.

   Article 39 Medical devices shall have instructions and labels. The contents of the instructions and labels shall be consistent with the relevant contents registered or filed to ensure authenticity and accuracy.

   The instructions and labels of medical devices should indicate the following items:

   (1) Common name, model, specification;

   (2) The name, address and contact information of the medical device registrant, recorder, and entrusted manufacturer;

  (3) Production date, expiration date or expiration date;

   (4) Product performance, main structure, and scope of application;

  (5) Taboos, precautions, and other content that requires warning or reminder;

  (6) Installation and use instructions or diagrams;

  (7) Maintenance and maintenance methods, special transportation and storage conditions and methods;

   (8) Other content that should be indicated in the product technical requirements.

   The second and third category medical devices should also be marked with the medical device registration certificate number.

  Medical devices used by consumers themselves should also have special instructions for safe use.

   Chapter 4 Operation and Use of Medical Devices

   Article 40 To engage in medical device business activities, there should be a business place and storage conditions that are compatible with the business scale and scope of business, as well as a quality management system and quality management organization or personnel that are compatible with the medical devices being operated.

  Article 41 For those engaged in the business of Class II medical devices, the business enterprise shall file with the department responsible for drug supervision and administration of the municipal people's government at the districted level and submit relevant materials that meet the requirements of Article 40 of these regulations.

  According to the regulations of the State Council’s drug regulatory department, Class II medical devices whose product safety and effectiveness are not affected by the circulation process can be exempted from business filing.

   Article 42 For those engaged in the operation of Class III medical devices, the operating enterprise shall apply to the department in charge of drug supervision and management of the municipal people's government at the districted level and submit relevant materials that meet the requirements of Article 40 of these Regulations.

  The department responsible for drug supervision and administration that accepts the application for business license shall review the application materials, organize verification if necessary, and make a decision within 20 working days from the date of acceptance of the application. For those that meet the prescribed conditions, the license is granted and a medical device business license is issued; for those that do not meet the prescribed conditions, the license is not granted and the reasons are stated in writing.

   The medical device business license is valid for 5 years. If the validity period expires and needs to be renewed, the renewal procedures shall be handled in accordance with the legal provisions of the relevant administrative license.

   Article 43 Medical device registrants and recorders who operate their registered and record medical devices do not need to apply for a medical device business license or record, but they should meet the operating conditions stipulated in these regulations.

Article 44 To engage in the operation of medical devices, one shall establish and improve a quality management system suitable for the medical devices operated in accordance with the laws and regulations and the requirements of the medical device operation quality management standards formulated by the drug regulatory department of the State Council, and ensure its effective writing .

   Article 45 Medical device business enterprises and user units shall purchase medical devices from legally qualified medical device registrants, recorders, and production and business enterprises. When purchasing medical devices, the supplier’s qualifications and medical device qualification certificates shall be checked, and a record system for purchasing inspection records shall be established. Business enterprises engaged in the wholesale business of Type II and Type III medical devices and the retail business of Type III medical devices shall also establish a sales record system.

   Record items include:

   (1) The name, model, specification, and quantity of the medical device;

   (2) The production batch number, expiration date or expiration date of the medical device;

   (3) The names of the medical device registrant, recorder and entrusted manufacturer;

   (4) The name, address and contact information of the supplier or purchaser;

  (5) Numbers of relevant license certificates, etc.

   Purchase inspection records and sales records shall be true, accurate, complete and traceable, and shall be kept in accordance with the time limit prescribed by the drug regulatory department of the State Council. The state encourages the use of advanced technical means for recording.

   Article 46 Anyone engaged in online sales of medical devices shall be the medical device registrant, recorder or medical device business enterprise. Operators engaged in online sales of medical devices shall inform the relevant information about online sales of medical devices to the department responsible for drug supervision and administration of the people’s government at the districted city level, and operate Class I medical devices and Article 41 of these Regulations. Except for the second-class medical devices specified in paragraph 2.

  E-commerce platform operators that provide services for medical device online transactions shall register real-name medical device operators, review their business licenses, filing conditions, and the medical device product registration and filing conditions, and manage their business operations. If an e-commerce platform operator discovers that the networked medical device operator has violated the provisions of these Regulations, it shall stop and immediately report to the medical device operator’s location of the districted municipal people’s government responsible for drug supervision and management; if serious violations are found, The provision of online trading platform services should be stopped immediately.

   Article 47 The transportation and storage of medical devices shall comply with the requirements of the medical device instructions and labeling; if there are special requirements for environmental conditions such as temperature and humidity, corresponding measures shall be taken to ensure the safety and effectiveness of the medical devices.

   Article 48 The medical device user unit shall have a storage place and conditions suitable for the variety and quantity of the medical device in use. The medical device user unit shall strengthen the technical training of the staff, and use the medical device in accordance with the requirements of the product manual and technical operation specifications.

The deployment of large-scale medical equipment by the medical device user unit shall comply with the large-scale medical equipment configuration plan formulated by the health authority of the State Council, meet its functional positioning and clinical service needs, and have corresponding technical conditions, supporting facilities, and professional technology with corresponding qualifications and capabilities. Personnel, and have been approved by the health authorities of the people’s government at or above the provincial level to obtain a large-scale medical equipment configuration permit.

   The measures for the management of large-scale medical equipment configuration are formulated by the health department of the State Council in conjunction with relevant departments of the State Council. The list of large-scale medical equipment is proposed by the competent health department of the State Council in consultation with the relevant departments of the State Council, and implemented after being approved by the State Council.

   Article 49 Medical device users shall dispose of reusable medical devices in accordance with the regulations on disinfection and management formulated by the competent health department of the State Council.

   Disposable medical devices shall not be reused, and the used ones shall be destroyed and recorded in accordance with relevant national regulations. The list of single-use medical devices shall be formulated, adjusted and announced by the State Council's drug regulatory authority to the State Council's health authority. To be included in the list of single-use medical devices, there should be sufficient evidence that cannot be reused. Medical devices that can be reused to ensure safety and effectiveness are not included in the list of single-use medical devices. For medical devices whose design, production process, disinfection and sterilization technology, etc. are improved after repeated use can be guaranteed to be safe and effective, a single-use medical device catalog should be adjusted to allow repeated use.

Article 50: For medical devices that require regular inspection, inspection, calibration, maintenance, and maintenance, medical device users shall conduct inspection, inspection, calibration, maintenance, and maintenance in accordance with the requirements of the product manuals, and record them, and conduct analysis and evaluation in a timely manner. Ensure that medical devices are in good condition and guarantee the quality of use; for large-scale medical devices with a long service life, use files should be established one by one to record their use, maintenance, transfer, actual use time and other matters. The record retention period shall not be less than 5 years after the expiration of the prescribed use period of the medical device.

   Article 51 Medical device users shall properly preserve the original materials of the third-class medical devices purchased, and ensure that the information is traceable.

  Where large-scale medical devices and implantable and interventional medical devices are used, the name of the medical device, key technical parameters and other information, as well as necessary information closely related to the quality and safety of use, shall be recorded in relevant records such as medical records.

Article 52 If the medical device used is found to have potential safety hazards, the medical device user shall immediately stop using it, and notify the medical device registrant, recorder or other organization responsible for product quality to perform maintenance; after the maintenance, the safety of use cannot be achieved. Standard medical equipment must not be used any more.

   Article 53 For in-vitro diagnostic reagents that do not have the same product on the market in China, qualified medical institutions can develop them on their own according to the clinical needs of their own units, and use them in their own units under the guidance of practicing physicians. The specific management measures shall be formulated by the drug regulatory department of the State Council in conjunction with the competent health department of the State Council.

   Article 54 The department in charge of drug supervision and administration and the health authority shall, in accordance with their respective responsibilities, supervise and manage the quality of medical devices and the behavior of medical devices in use.

   Article 55 Medical device business enterprises and user units shall not operate or use medical devices that have not been registered or filed in accordance with the law, have no qualified certification documents, and have expired, expired, or eliminated.

   Article 56 When medical device users transfer medical devices in use between medical device users, the transferor shall ensure that the transferred medical devices are safe and effective, and shall not transfer expired, invalid, obsolete or unqualified medical devices.

   Article 57 The imported medical devices shall be medical devices that have been registered or filed in accordance with the provisions of Chapter 2 of these Regulations.

  Imported medical devices should have Chinese instructions and Chinese labels. The instructions and labels shall comply with the requirements of these regulations and relevant mandatory standards, and the instructions shall state the origin of the medical device and the name, address and contact information of the domestic enterprise legal person designated by the overseas medical device registrant and filing party. No Chinese instructions, Chinese labels, or instructions or labels that do not comply with the provisions of this Article shall not be imported.

  

If a medical institution urgently needs to import a small amount of Class II and Class III medical devices for clinical reasons, they may import them with the approval of the State Council’s drug regulatory authority or the people’s government of a province, autonomous region, or municipality authorized by the State Council. Imported medical devices shall be used for specific medical purposes in designated medical institutions.

  It is forbidden to import expired, expired, obsolete and other used medical devices.

  Article 58 The entry-exit inspection and quarantine agency shall conduct inspections on imported medical devices in accordance with the law; those that fail the inspection shall not be imported.

   The State Council’s drug regulatory authority shall promptly notify the national entry-exit inspection and quarantine department of the registration and filing of imported medical devices. The entry-exit inspection and quarantine agency where the import port is located shall promptly report the customs clearance status of imported medical devices to the drug supervision and administration department of the municipal people's government with districts.

   Article 59 Enterprises exporting medical devices shall ensure that the medical devices they export meet the requirements of the importing country (region).

   Article 60 The content of medical device advertisements shall be true and legal, and shall be subject to the medical device instructions registered or filed by the department responsible for drug supervision and administration, and shall not contain false, exaggerated, or misleading content.

   To publish a medical device advertisement, the advertisement review agency designated by the people's government of the province, autonomous region, or municipality directly under the Central Government shall review the content of the advertisement and obtain the approval number of the medical device advertisement; it shall not be published without review.

   The drug supervision and administration department of the people's government at or above the provincial level shall order the suspension of the production, import, operation and use of medical devices. During the suspension period, advertisements involving the medical devices shall not be published.

   The measures for reviewing medical device advertisements are formulated by the market supervision and management department of the State Council.

   Chapter 5 Handling of Adverse Events and Recall of Medical Devices

   Article 61 The state establishes a medical device adverse event monitoring system to collect, analyze, evaluate, and control medical device adverse events in a timely manner.

Article 62 Medical device registrants and recorders shall establish a medical device adverse event monitoring system, be equipped with adverse event monitoring institutions and personnel suitable for their products, actively carry out adverse event monitoring for their products, and follow the guidelines of the drug regulatory authority under the State Council According to the regulations, report investigation, analysis, evaluation, product risk control, etc. to the medical device adverse event monitoring technical agency.

Medical device manufacturers and users shall assist medical device registrants and recorders in monitoring the adverse events of the medical devices produced, operated or used; discovering medical device adverse events or suspicious adverse events shall comply with the regulations of the State Council’s drug regulatory authority , To report to the technical agency for medical device adverse event monitoring.

   Other units and individuals who discover medical device adverse events or suspicious adverse events have the right to report to the department in charge of drug supervision and management or medical device adverse event monitoring technical institutions.

   Article 63 The drug regulatory department of the State Council shall strengthen the construction of a medical device adverse event monitoring information network.

Medical device adverse event monitoring technical institutions should strengthen the monitoring of medical device adverse event information, and actively collect information on adverse events; if adverse events are discovered or received, they should be verified in a timely manner, and investigation, analysis, and evaluation should be carried out when necessary, and they should be reported to the responsible drug Supervising and managing departments and health authorities report and put forward suggestions for handling.

  Medical device adverse event monitoring technical institutions shall publish contact information to facilitate medical device registrants, record holders, production and operation enterprises, users, etc. to report medical device adverse events.

   Article 64 The department responsible for drug supervision and administration shall, based on the assessment results of adverse events of medical devices, take timely control measures such as issuing warning information and ordering the suspension of production, import, operation and use.

The drug supervision and administration department of the people's government at or above the provincial level shall, in conjunction with the health authorities and relevant departments at the same level, organize timely investigation and treatment of medical device adverse events that cause sudden, mass injuries or deaths, and organize strengthened monitoring of similar medical devices .

  The department responsible for the supervision and administration of drugs shall promptly notify the health authorities at the same level of the adverse event monitoring of the medical device user unit.

   Article 65 Medical device registrants, record holders, production and operation enterprises, and user units shall cooperate with medical device adverse event monitoring technical institutions, drug supervision and management departments, and health authorities in the investigation of medical device adverse events.

   Article 66 In any of the following circumstances, the medical device registrant and recorder shall take the initiative to carry out the re-evaluation of the medical device that has been marketed:

   (1) According to the development of scientific research, there is a change in the understanding of the safety and effectiveness of medical devices;

   (2) The results of the monitoring and evaluation of the adverse event of the medical device indicate that the medical device may have defects;

   (3) Other circumstances specified by the drug regulatory department of the State Council.

  Medical device registrants and filing parties shall, based on the results of the re-evaluation, take corresponding control measures to improve the medical devices already on the market, and make registration changes or filing changes in accordance with regulations. If the result of the re-evaluation shows that the safety and effectiveness of the medical device on the market cannot be guaranteed, the medical device registrant and recorder shall take the initiative to apply for cancellation of the medical device registration certificate or cancellation of the record; the medical device registrant or recorder has not applied for the cancellation of the medical device registration certificate or cancellation In case of filing, the medical device registration certificate shall be cancelled or the filing shall be cancelled by the department responsible for drug supervision and administration.

   The drug supervision and administration department of the people's government at or above the provincial level conducts re-evaluation of medical devices that have been marketed based on the monitoring and evaluation of adverse events of medical devices. If the result of the re-evaluation shows that the safety and effectiveness of the medical device on the market cannot be guaranteed, the medical device registration certificate shall be cancelled or the filing shall be cancelled.

  The department responsible for drug supervision and administration shall promptly announce the cancellation of the medical device registration certificate and the cancellation of the record to the public. Medical devices whose registration certificates for medical devices have been cancelled or whose filings have been cancelled shall not continue to be produced, imported, operated, or used.

Article 67 If the medical device registrant or filing person discovers that the medical device produced does not meet the mandatory standards, the technical requirements of the registered or filed product, or has other defects, it shall immediately stop production and notify the relevant operating enterprise and user unit Stop business and use with consumers, recall medical devices that have been on the market, take measures such as remediation and destruction, record relevant conditions, release relevant information, and report the recall and handling of medical devices to the department responsible for drug supervision and management and the health authority Report.

  Medical device entrusted manufacturing enterprises and operating enterprises discovering that the production and operation of medical devices are in the circumstances specified in the preceding paragraph shall immediately stop production and operation, notify the medical device registrant and recorder, and record the suspension of production, operation and notification. The medical device registrant and recorder believe that the medical device that needs to be recalled in accordance with the provisions of the preceding paragraph shall be recalled immediately.

   If a medical device registrant, recorder, entrusted production enterprise, or operating enterprise fails to implement a recall or stop production or operation in accordance with the provisions of this article, the department responsible for drug supervision and administration may order it to recall or stop production or operation.

   Chapter VI Supervision and Inspection

   Article 68 The State establishes a system of professional and specialized inspectors to strengthen the supervision and inspection of medical devices.

   Article 69 The department in charge of drug supervision and administration shall strengthen the supervision and inspection of the quality of medical devices in the development, production, operation and use of medical devices, and conduct key supervision and inspection on the following matters:

  (1) Whether the production is organized in accordance with the registered or filed product technical requirements;

   (2) Whether the quality management system maintains effective operation;

   (3) Whether the production and operation conditions continue to meet the legal requirements.

   When necessary, the department responsible for drug supervision and administration may conduct extended inspections of other relevant units and individuals that provide products or services for medical device development, production, operation, and use.

   Article 70 The department in charge of drug supervision and administration shall have the following powers in supervision and inspection:

   (1) Enter the site to conduct inspections and take samples;

  (2) Consult, copy, seal up, and detain relevant contracts, bills, account books and other relevant materials;

  (3) Seal up and seize medical devices that do not meet statutory requirements, illegally used spare parts, raw materials, and tools and equipment used for illegal production and operation of medical devices;

  (4) Seal up places that violate the provisions of these Regulations and engage in the production and operation of medical devices.

   In conducting supervision and inspection, law enforcement certificates shall be presented to keep the business secrets of the entity under inspection.

  Relevant units and individuals shall cooperate in supervision and inspection, provide relevant documents and materials, and shall not conceal, refuse, or obstruct.

   Article 71 The competent health department shall strengthen supervision and inspection of the use of medical devices by medical institutions. When conducting supervision and inspection, you can enter a medical institution to consult and copy relevant files, records and other relevant materials.

  Article 72 If there are hidden product quality and safety hazards in the production and operation of medical devices, and no timely measures are taken to eliminate them, the department responsible for drug supervision and management may take measures such as warnings, responsibility interviews, and ordering rectification within a time limit.

   For medical devices that cause harm to the human body or have evidence that may endanger human health, the department responsible for drug supervision and administration can take emergency control measures that order the suspension of production, import, operation, and use, and issue safety warning information.

   Article 73 The department responsible for drug supervision and administration shall strengthen the random inspection and inspection of medical device registrants, record holders, production and operation enterprises and users of medical devices produced, operated, and used. Random inspections shall not be charged for inspection fees and any other expenses, and the necessary expenses shall be included in the budget of the government at the same level. The drug supervision and administration department of the people's government at or above the provincial level shall issue a medical device quality announcement in a timely manner based on the conclusions of random inspections.

   The competent health department shall supervise and evaluate the use of large-scale medical equipment; if any illegal use and excessive inspection and over-treatment related to large-scale medical equipment are found, they shall be corrected immediately and dealt with in accordance with the law.

Article 74 If the department responsible for drug supervision and management fails to discover the systemic risks of medical device safety in time, and fails to eliminate the hidden dangers of medical device safety in the supervision and management area in time, the people's government at the same level or the department in charge of the drug supervision and management of the people's government at a higher level shall deal with it. The main person in charge conducts an interview.

   If the local people's government fails to perform its medical device safety responsibilities and fails to eliminate major regional medical device safety hazards in a timely manner, the higher-level people's government or the drug supervision and administration department of the higher-level people's government shall hold an interview with its main person in charge.

  The department interviewed and the local people's government should take immediate measures to rectify the supervision and management of medical devices.

   Article 75 The qualification accreditation of medical device inspection institutions shall be managed in a unified manner in accordance with relevant national regulations. Only the inspection agency recognized by the certification and accreditation supervision and management department of the State Council and the drug regulatory department of the State Council can carry out inspections on medical devices.

   If the department in charge of drug supervision and management needs to inspect medical devices in law enforcement work, it shall entrust a qualified medical device inspection agency to conduct the inspection and pay the relevant expenses.

If the parties have objections to the inspection conclusions, they may submit an application for re-inspection to the department that conducts sampling inspection or the department responsible for drug supervision and administration at the next higher level within 7 working days from the date of receipt of the inspection conclusion, and the department that accepts the re-inspection application The re-inspection agency is randomly selected in the list of re-inspection agencies to conduct re-inspection. The medical device inspection agency undertaking the re-inspection work shall make a re-inspection conclusion within the time specified by the drug regulatory authority under the State Council. The re-inspection conclusion is the final inspection conclusion. The re-inspection institution and the initial inspection institution shall not be the same institution; if there is only one qualified inspection institution for the relevant inspection items, the undertaking department or personnel shall be changed during the re-inspection. The list of re-inspection agencies shall be announced by the drug regulatory department of the State Council.

Article 76 For medical devices that may contain harmful substances or change the design, raw materials and production processes of medical devices without authorization and have hidden safety hazards, medical devices that cannot be inspected in accordance with the inspection items and inspection methods specified in the national standards and industry standards for medical devices The inspection agency may use the supplementary inspection items and inspection methods approved by the drug regulatory department of the State Council for inspection; the inspection conclusions drawn from the supplementary inspection items and inspection methods can be used as the basis for the quality of medical devices recognized by the drug regulatory authority.

   Article 77 The market supervision and management department shall supervise and inspect medical device advertisements in accordance with the relevant advertising management laws and administrative regulations, and investigate and deal with illegal acts.

  Article 78 The department responsible for drug supervision and administration shall, through the online government service platform of the drug supervision and administration department of the State Council, promptly announce the daily supervision and management information of medical device licensing, filing, random inspection, investigation and punishment of illegal activities in accordance with the law. However, the commercial secrets of the parties concerned shall not be disclosed.

  The department responsible for drug supervision and management shall establish credit files for medical device registrants, record holders, production and operation enterprises, and users, increase the frequency of supervision and inspection for those with bad credit records, and strengthen punishments for untrustworthiness in accordance with the law.

   Article 79 The department in charge of drug supervision and administration and other departments shall publish the contact information of the unit, and accept consultation, complaints and reports. The departments responsible for drug supervision and management and other departments shall respond in time when receiving inquiries related to the supervision and management of medical devices; upon receipt of complaints and reports, they shall verify, handle and respond in a timely manner. The consultations, complaints, and reports, as well as their responses, verifications, and handling, shall be recorded and kept.

   If a report on medical device development, production, operation, and use is true after investigation, the department responsible for drug supervision and administration and other departments shall reward the reporter. Relevant departments shall keep the reporter confidential.

Article 80: The drug regulatory department of the State Council formulates, adjusts, and revises the catalogs and regulations related to the supervision and management of medical devices, and it shall solicit public opinions; take the form of hearings, demonstration meetings, etc., to listen to experts and medical device registrants , The opinions of the filing person, production and operation enterprises, user units, consumers, industry associations and related organizations.

   Chapter VII Legal Liability

Article 81: In any of the following circumstances, the department responsible for drug supervision and administration shall confiscate illegal income, illegal production and operation of medical devices, and tools, equipment, raw materials and other items used in illegal production and operation; illegal production and operation of medical devices If the value of the goods is less than 10,000 yuan, a fine of more than 50,000 yuan and less than 150,000 yuan shall be imposed; if the value of the goods is more than 10,000 yuan, a fine of 15 times to 30 times the value of the goods shall be imposed; if the circumstances are serious, production and business shall be suspended , Within 10 years, do not accept medical device license applications submitted by relevant responsible persons and units. The legal representative, main responsible person, directly responsible person in charge and other responsible persons of the illegal unit will be confiscated from the unit’s income during the occurrence of the illegal act. , And impose a fine of more than 30% of income but not more than 3 times, and prohibit them from engaging in medical device production and operation activities for life:

   (1) Production and operation of Class II and Class III medical devices that have not obtained a medical device registration certificate;

   (2) Engaging in the production of Class II and Class III medical devices without permission;

  

(3) Engaging in the third-class medical device business activities without permission.

   In the case of the first item of the preceding paragraph and the circumstances are serious, the medical device production license or medical device business license shall be revoked by the original license-issuing department.

Article 82: Anyone who deploys and uses large-scale medical equipment without permission shall be ordered by the health authority of the people’s government at or above the county level to stop the use, give a warning, and confiscate the illegal income; if the illegal income is less than 10,000 yuan, a penalty of more than 50,000 yuan shall be imposed. A fine of less than 100,000 yuan; if the illegal income is more than 10,000 yuan, a fine of 10 times to 30 times the illegal income shall also be imposed; if the circumstances are serious, the application for large-scale medical equipment configuration license submitted by the relevant responsible person and the unit will not be accepted within 5 years. The legal representative, the main person in charge, the directly responsible person in charge and other responsible persons of the unit shall confiscate the income received from the unit during the period of the illegal act, and impose a fine of more than 30% but not more than 3 times of the income, and shall be punished in accordance with the law.

Article 83: Where false information is provided or other deceptive methods are used when applying for an administrative license for medical devices, the administrative license shall not be granted. If the administrative license has been obtained, the administrative license shall be revoked by the department that made the administrative license decision, and the illegal income and illegal production shall be confiscated. For medical devices used in business, applications for medical device licenses submitted by relevant responsible persons and units will not be accepted within 10 years; medical devices used in illegal production and operation with a value of less than 10,000 yuan will be fined between 50,000 yuan and 150,000 yuan; If the value of the goods is more than 10,000 yuan, a fine of 15 times to 30 times the value of the goods shall be imposed; if the circumstances are serious, the production and business shall be suspended, and the legal representative, the main person in charge, the directly responsible person in charge and other responsibilities of the illegal unit Personnel, confiscate the income received from the unit during the period of the illegal act, and impose a fine of more than 30% of the income but not more than 3 times, and prohibit them from engaging in the production and operation of medical devices for life.

Anyone who forges, alters, sells, leases, or lends relevant medical device licenses shall be confiscated or revoked by the original license-issuing department, and the illegal gains shall be confiscated; if the illegal gains are less than 10,000 yuan, a fine of 50,000 yuan up to 100,000 yuan shall be imposed. ; If the illegal income is more than 10,000 yuan, a fine of 10 times to 20 times the illegal income shall be imposed; if a violation of public security management is constituted, the public security organ shall impose public security management penalties in accordance with the law.

Article 84 In any of the following circumstances, the department responsible for drug supervision and administration shall announce the name of the unit and product to the public and order it to make corrections within a time limit; if the correction is not made within the time limit, the illegal income and medical devices produced and operated illegally shall be confiscated; illegal production and operation If the value of the medical device is less than 10,000 yuan, a fine of 10,000 yuan or more and less than 50,000 yuan shall be imposed; if the value of the medical device is more than 10,000 yuan, a fine of 5 times or more and 20 times the value of the value shall be imposed; if the circumstances are serious, The legal representative, main person in charge, directly responsible person in charge and other responsible personnel of the illegal unit shall confiscate the income received from the unit during the period of the illegal act, and impose a fine of more than 30% and less than 2 times of the income. Prohibited within 5 years It is engaged in the production and operation of medical devices:

   (1) Production and operation of undocumented Class I medical devices;

   (2) Engaging in the production of Class I medical devices without filing;

   (3) The operation of Class II medical devices shall be filed but not filed;

   (4) The filed materials do not meet the requirements.

Article 85: Where false information is provided during filing, the department responsible for drug supervision and administration shall announce the name of the filing unit and product to the public, and confiscate illegal income and illegally produced and operated medical devices; the value of illegally produced and operated medical devices is less than 1 If the value is more than 10,000 yuan, a fine of more than 20,000 yuan and less than 50,000 yuan shall be imposed; if the value of the goods is more than 10,000 yuan, a fine of more than 5 times and less than 20 times the value of the goods shall be imposed; if the circumstances are serious, production and business shall be suspended; The legal representative, the main person in charge, the directly responsible person in charge and other responsible persons shall confiscate the income received from the unit during the period of the illegal act, and shall impose a fine of 30% or more but less than 3 times the income, and shall be prohibited from engaging in medical equipment for 10 years Production and business activities.

Article 86 In any of the following circumstances, the department responsible for drug supervision and administration shall order corrections and confiscate the medical devices used in illegal production and operation; if the value of the medical devices used in illegal production and operation is less than 10,000 yuan, they shall be punished 2 A fine of not less than 10,000 yuan but not more than 50,000 yuan; if the value of the goods is more than 10,000 yuan, a fine of 5 times to 20 times the value of the goods shall be imposed; if the circumstances are serious, the production and business shall be suspended until the medical device registration certificate is revoked by the original issuing department , Medical device production license, medical device business license, the legal representative, main person in charge, directly responsible person in charge and other responsible personnel of the illegal unit shall confiscate the income obtained from the unit during the period of the illegal act and the premises Receive a fine of more than 30% of income but less than 3 times, and prohibit them from engaging in medical device production and operation activities for 10 years:

  (1) The production, operation, and use of medical devices that do not meet mandatory standards or do not meet the technical requirements of registered or filed products;

  (2) Failing to organize production in accordance with the registered or filed product technical requirements, or failing to establish a quality management system and maintain effective operation in accordance with the provisions of these regulations, which affects the safety and effectiveness of the product;

  (3) Operating or using medical devices that do not have conformity certification documents, expired, invalidated, or eliminated, or use medical devices that are not legally registered;

  (4) Refusal to refuse the recall even after the department in charge of drug supervision and administration orders the recall, or refuse to stop the production, import, or operation of medical devices even after the department in charge of drug supervision and administration orders to stop or suspend production, import, or operation;

  (5) Entrust an enterprise that does not meet the requirements of these regulations to produce medical devices, or fail to manage the production activities of the entrusted production enterprise;

  (6) Import expired, expired, obsolete and other used medical devices. Article 87 Medical device operating enterprises and user units have fulfilled the obligations of purchase inspection and other obligations stipulated in these Regulations, and have sufficient evidence to prove that they do not know that the medical devices they operate and use are the first paragraph of Article 81 of the Regulations. If the medical devices under the conditions specified in paragraph 1 of Article 84, paragraph 1 of Article 86, and paragraph 3 of Article 86, and the source of their purchase can be truthfully stated, the medical devices that they operate and use that do not meet the statutory requirements shall be confiscated Equipment can be exempted from administrative penalties.

Article 88 In any of the following circumstances, the department responsible for drug supervision and administration shall order corrections and impose a fine of 10,000 yuan up to 50,000 yuan; if it refuses to make corrections, a fine of 50,000 yuan up to 100,000 yuan shall be imposed; circumstances In serious cases, it shall be ordered to suspend production and business until the original license-issuing department revokes the medical device production license and medical device business license. The legal representative, main responsible person, directly responsible person in charge and other responsible personnel of the illegal unit shall be confiscated. During the period of the act, the income received from the unit, and a fine of more than 30% of the income received but not more than 2 times, is prohibited from engaging in the production and operation of medical devices for 5 years:

   (1) The production conditions have changed, the medical device quality management system requirements are no longer met, and the rectification, cessation of production, and reporting have not been made in accordance with the provisions of these regulations;

   (2) Medical devices whose production and operation manuals and labels do not meet the requirements of these regulations;

   (3) Failing to transport and store medical devices in accordance with the medical device instructions and labeling requirements;

   (4) Transfer of medical devices in use that have expired, become invalid, obsolete, or have failed inspections.

Article 89 In any of the following circumstances, the department responsible for drug supervision and administration and the competent health department shall order corrections and give warnings according to their respective duties; if they refuse to make corrections, a fine of 10,000 yuan but less than 100,000 yuan shall be imposed; the circumstances are serious If the company is involved, it shall be ordered to suspend production and business until the medical device registration certificate, medical device production license, and medical device business license are revoked by the original issuing authority, and the legal representative, main person in charge, directly responsible person in charge and other responsibilities of the illegal entity The personnel shall be fined not less than 10,000 yuan but not more than 30,000 yuan:

   (1) Failure to submit the quality management system self-inspection report as required;

  (2) Purchase medical devices from suppliers who do not have legal qualifications;

   (3) Medical device operating companies and user units fail to establish and implement a medical device purchase inspection record system in accordance with these regulations;

  (4) Operating companies engaged in the second and third category medical device wholesale business and the third category medical device retail business fail to establish and implement a sales record system in accordance with the provisions of these regulations;

(5) Medical device registrants, record holders, production and operation enterprises, and user units fail to carry out medical device adverse event monitoring in accordance with the provisions of these Regulations, fail to report adverse events in accordance with requirements, or monitor technical institutions for medical device adverse events and are responsible for drug supervision and management Failing to cooperate in the investigation of adverse events carried out by the relevant departments and health authorities;

  (6) The medical device registrant and recorder failed to formulate a post-marketing research and risk control plan in accordance with the regulations and ensure effective implementation;

   (7) The medical device registrant and filing person failed to establish and implement a product traceability system in accordance with the regulations;

   (8) Medical device registrants, recorders, and operating companies engaged in online sales of medical devices fail to notify the department responsible for drug supervision and administration in accordance with regulations;

(9) For medical devices that require regular inspection, inspection, calibration, maintenance, and maintenance, the medical device user fails to perform inspection, inspection, calibration, maintenance, maintenance and records in accordance with the requirements of the product manual, and conduct analysis and evaluation in time to ensure medical treatment The device is in good condition;

  (10) The user of the medical device did not properly keep the original data of the third-class medical device purchased.

Article 90: In any of the following circumstances, the competent health department of the people’s government at or above the county level shall order corrections and give warnings; if they refuse to make corrections, a fine of 50,000 yuan but less than 100,000 yuan shall be imposed; if the circumstances are serious, 100,000 yuan shall be imposed For fines above 300,000 yuan or less, the relevant medical device use activities shall be suspended until the original license issuing department revokes the practice license, and the relevant responsible personnel shall be ordered to suspend the practice activities for more than 6 months and less than 1 year until the original license issuing department revokes the relevant activities. Personnel practice certificate, the legal representative, main person in charge, directly responsible person in charge and other responsible personnel of the illegal unit shall confiscate the income received from the unit during the period of the illegal act, and impose a fine of 30% or more and less than 3 times the income. , To be punished in accordance with the law:

  (1) For reusable medical devices, the medical device user unit fails to handle it in accordance with the provisions of disinfection and management;

   (2) Medical device users reuse single-use medical devices, or fail to destroy used single-use medical devices in accordance with regulations;

   (3) The medical device user fails to record the information of large-scale medical devices and implantable and interventional medical devices in relevant records such as medical records in accordance with regulations;

   (4) The medical device user discovers that the medical device used has a potential safety hazard and fails to immediately stop using it, notify it for maintenance, or continue to use the medical device that cannot meet the safety standards after the maintenance;

  (5) Medical device users use large-scale medical equipment in violation of regulations and cannot guarantee medical quality and safety.

   Article 91 Imported medical devices in violation of relevant laws and administrative regulations on import and export commodity inspection shall be dealt with by the entry-exit inspection and quarantine agency in accordance with the law.

Article 92 Operators of e-commerce platforms that provide services for medical device online transactions violate the provisions of these Regulations by failing to perform real-name registration of online medical device operators, review licensing, registration, and filing conditions, stop and report illegal acts, and stop Those who provide management obligations such as online trading platform services shall be punished by the department responsible for drug supervision and management in accordance with the provisions of the "E-commerce Law of the People's Republic of China".

Article 93 If a clinical trial is carried out without a record of a medical device clinical trial institution, the department in charge of drug supervision and administration shall order it to stop the clinical trial and make corrections; if it refuses to make corrections, the clinical trial data shall not be used for product registration, filing, and processing. A fine of 50,000 yuan to 100,000 yuan shall be fined and an announcement shall be made to the public; if serious consequences are caused, it shall be prohibited from conducting clinical trials of related professional medical devices within 5 years, and a fine of 100,000 yuan but less than 300,000 yuan shall be imposed. The legal representative, the main person in charge, the directly responsible person in charge and other responsible persons of the unit shall confiscate the income received from the unit during the period of the illegal act, and impose a fine of more than 30% but not more than 3 times of the income, and shall be punished in accordance with the law.

If a clinical trial sponsor has carried out a clinical trial without filing, the department in charge of drug supervision and management shall order the suspension of the clinical trial, impose a fine of 50,000 yuan up to 100,000 yuan on the clinical trial sponsor, and announce to the public; if serious consequences are caused, Impose a fine of 100,000 yuan up to 300,000 yuan. The clinical trial data shall not be used for product registration and filing, and medical device registration applications submitted by relevant responsible persons and units will not be accepted within 5 years.

If a clinical trial sponsor conducts a third-class medical device clinical trial that has a higher risk to the human body without approval, the department responsible for drug supervision and management shall order the immediate termination of the clinical trial, and the clinical trial sponsor shall impose a penalty of 100,000 yuan to 300,000 yuan The following fines shall be announced to the public; if serious consequences are caused, a fine of 300,000 yuan up to 1 million yuan shall be imposed. The clinical trial data shall not be used for product registration, and the medical device clinical trial and registration applications submitted by relevant responsible persons and units will not be accepted within 10 years. The legal representative, main responsible person, directly responsible person in charge and other responsible persons of the illegal unit will not be accepted. , Confiscate the income received from the unit during the period of the illegal act, and impose a fine of 30% or more and less than 3 times the income.

Article 94 If a medical device clinical trial institution conducts a medical device clinical trial that fails to comply with the clinical trial quality management norms, the department responsible for drug supervision and management shall order it to make corrections or immediately stop the clinical trial, and impose a fine of 50,000 yuan up to 100,000 yuan; If serious consequences are caused, they are prohibited from conducting clinical trials of related professional medical devices within 5 years, and the health authority shall confiscate the legal representative, the main person in charge, the directly responsible person in charge, and other responsible personnel of the illegal unit during the period of the illegal act. The income earned by a unit and a fine of more than 30% and less than three times the income received shall be punished in accordance with the law.

Article 95 If a medical device clinical trial institution issues a false report, the department responsible for drug supervision and administration shall impose a fine of 100,000 yuan up to 300,000 yuan; if there are illegal gains, the illegal gains shall be confiscated; the relevant professional medical treatment shall be prohibited within 10 years Device clinical trials; the legal representative, main responsible person, directly responsible person in charge and other responsible personnel of the illegal unit shall be confiscated by the health authority of the unit’s income during the occurrence of the illegal act, and more than 30% of the income obtained from the premises shall be confiscated 3 A fine of less than twice the amount shall be punished in accordance with the law.

Article 96: If a medical device inspection agency issues a false inspection report, the competent authority granting its qualifications shall revoke the inspection qualifications, and shall not accept the qualification accreditation applications submitted by the relevant responsible persons and units within 10 years, and impose a penalty of 100,000 yuan or more and 300,000 yuan or more. The following fines; where there is illegal income, the illegal income shall be confiscated; the legal representative, the main responsible person, the directly responsible person in charge and other responsible persons of the illegal unit shall confiscate the income obtained from the unit during the period of the illegal act and dispose of the income obtained A fine of more than 30% of income and less than 3 times of the income shall be punished according to law; those who are expelled shall be prohibited from engaging in medical device inspection work for 10 years.

  

Article 97 Violation of the regulations on the management of medical device advertising shall be punished in accordance with the provisions of the Advertising Law of the People’s Republic of China.

Article 98: Where a domestic enterprise legal person designated by an overseas medical device registrant or filing person fails to perform relevant obligations in accordance with the provisions of these Regulations, the drug regulatory department of the people’s government of the province, autonomous region, or municipality directly under the Central Government shall order correction, give a warning, and impose a 5 A fine of not less than 10,000 yuan but not more than 100,000; if the circumstances are serious, a fine of 100,000 yuan but not more than 500,000 yuan shall be imposed, and the legal representative, main responsible person, directly responsible person in charge and other responsible persons are prohibited from engaging in medical device production and operation within 5 years Activity.

   If an overseas medical device registrant or filing person refuses to implement the administrative penalty decision made in accordance with these regulations, the import of medical devices shall be prohibited for 10 years.

Article 99 If medical device research and development, production, and operation units and inspection institutions violate these regulations and use personnel who are prohibited from engaging in medical device production and operation activities or inspections, the department responsible for drug supervision and administration shall order corrections and give warnings; refuse If it is corrected, it shall be ordered to suspend production and business until the license is revoked.

Article 100 If a medical device technical review institution or a medical device adverse event monitoring technical institution fails to perform its duties in accordance with the provisions of these Regulations, causing major errors in the review and monitoring work, the department responsible for drug supervision and administration shall order corrections and report criticisms. A warning shall be given; if serious consequences are caused, the legal representative, the main person in charge, the directly responsible person in charge and other responsible persons of the illegal unit shall be punished in accordance with the law.

  Article 101 Where the staff of the department responsible for drug supervision and administration or other relevant departments violates the provisions of these Regulations, abuses power, neglects their duties, or commits malpractices for personal gain, they shall be punished in accordance with the law.

   Article 102 Anyone who violates the provisions of these Regulations and constitutes a crime shall be investigated for criminal responsibility according to law; if personal, property or other damage is caused, he shall be liable for compensation according to law.

   Chapter 8 Supplementary Provisions

   Article 103 The meaning of the following terms in these regulations:

Medical devices used to refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly on the human body, including the required computer software; its utility is mainly obtained through physical methods, etc. It is not obtained through pharmacology, immunology, or metabolism, or although these methods are involved but only play a supporting role; its purpose is:

   (1) Diagnosis, prevention, monitoring, treatment or alleviation of diseases;

   (2) Injury diagnosis, monitoring, treatment, alleviation or functional compensation;

   (3) Inspection, substitution, adjustment or support of physiological structure or physiological process;

   (4) Life support or maintenance;

   (5) Pregnancy control;

  (6) Provide information for medical or diagnostic purposes by examining samples from the human body.

  Medical device registrant or filing person refers to an enterprise or research institution that has obtained a medical device registration certificate or handled medical device filing.

  Medical device user unit refers to an institution that uses medical devices to provide medical and other technical services to others, including medical institutions, family planning technical service institutions, blood stations, apheresis plasma stations, rehabilitation assistive device adaptation institutions, etc.

  Large-scale medical equipment refers to large-scale medical equipment with complex technology, large capital investment, high operating cost, large impact on medical expenses and included in catalog management.

   Article 104 A fee may be charged for the registration of medical device products. The specific charging items and standards shall be respectively formulated by the finance and price authorities of the State Council in accordance with relevant state regulations.

  Article 105 The management measures for medical devices developed by medical and health institutions in response to public health emergencies shall be formulated by the drug regulatory authority of the State Council in conjunction with the health authority of the State Council.

   The storage, allocation, and supply of non-profit contraceptive medical devices shall comply with the management measures formulated by the health department of the State Council in conjunction with the drug regulatory department of the State Council.

   The technical guidelines for medical devices in traditional Chinese medicine are formulated by the drug regulatory department of the State Council in conjunction with the traditional Chinese medicine regulatory department of the State Council.

   Article 106 The supervision and management of the use of military medical devices shall be implemented in accordance with these regulations and relevant military regulations.

   Article 107 These regulations shall come into force on June 1, 2021.

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Addd:No.67 Xianhong Road West, Xinlirenkou,Zhanggou Town,Xiantao City,433012 Hubei, P.R.China.
Phone: +86-728-2713 666
E-mail: vm001@v-medicalchina.com