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The Comprehensive Department of the State Food and Drug Administration publicly solicits opinions on the "Regulations on the Self-inspection of Medical Device Registration (Draft for Solicitation of Comments)"

The Comprehensive Department of the State Food and Drug Administration publicly solicits opinions on the "Regulations on the Self-inspection of Medical Device Registration (Draft for Solicitation of Comments)"

  • Categories:Industry News
  • Author:
  • Origin:奥咨达
  • Time of issue:2021-06-02
  • Views:0

(Summary description)In order to do a good job in the preparation and revision of supporting documents of the "Regulations on the Supervision and Administration of Medical Devices", the State Food and Drug Administration has further revised and improved the "Regulations on the Self-inspection of Medical Device Registration (Draft for Solicitation of Comments)" (see appendix) , Now again soliciting opinions from the public. Please send your feedback to the email address: ylqxzc@sina.cn. Please indicate "Feedback on Self-inspection Request" in the subject of the email.

The Comprehensive Department of the State Food and Drug Administration publicly solicits opinions on the "Regulations on the Self-inspection of Medical Device Registration (Draft for Solicitation of Comments)"

(Summary description)In order to do a good job in the preparation and revision of supporting documents of the "Regulations on the Supervision and Administration of Medical Devices", the State Food and Drug Administration has further revised and improved the "Regulations on the Self-inspection of Medical Device Registration (Draft for Solicitation of Comments)" (see appendix) , Now again soliciting opinions from the public. Please send your feedback to the email address: ylqxzc@sina.cn. Please indicate "Feedback on Self-inspection Request" in the subject of the email.

  • Categories:Industry News
  • Author:
  • Origin:奥咨达
  • Time of issue:2021-06-02
  • Views:0
Information

In order to do a good job in the preparation and revision of supporting documents of the "Regulations on the Supervision and Administration of Medical Devices", the State Food and Drug Administration has further revised and improved the "Regulations on the Self-inspection of Medical Device Registration (Draft for Solicitation of Comments)" (see appendix) , Now again soliciting opinions from the public. Please send your feedback to the email address: ylqxzc@sina.cn. Please indicate "Feedback on Self-inspection Request" in the subject of the email.

The deadline for feedback is July 31, 2021.

Attachment: Regulations on Self-inspection of Medical Device Registration (Draft for Solicitation of Comments)

Comprehensive Department of State Food and Drug Administration

July 23, 2021

Attachment

Regulations on self-inspection of medical device registration

(Draft for comments)

In order to strengthen the registration management of medical devices (including in vitro diagnostic reagents), standardize the registration and self-inspection of registration applicants, and ensure the orderly development of medical device registration review, according to the "Regulations on the Supervision and Administration of Medical Devices", "Measures for the Administration of Medical Device Registration", and "In Vitro Diagnostics" Reagent Registration Management Measures" formulated these regulations.
 
1. Self-inspection capability requirements
 
(1) Overall requirements
 
For self-inspection during registration, the registration applicant shall have the ability to self-inspect, incorporate the quality management of self-inspection work into the medical device production quality management system, be equipped with inspection equipment and facilities that meet the requirements of product inspection, and have a corresponding quality inspection department Or full-time inspectors, strictly control the inspection process to ensure that the inspection results are true, accurate, complete and traceable, and take the main responsibility for the self-inspection report.
 
(2) Inspection ability requirements
 
1. Personnel requirements. The registration applicant shall have management personnel and inspection personnel suitable for the inspection activities carried out. The applicant for registration shall be equipped with full-time inspectors, and the inspectors shall be officially hired personnel and can only work in the enterprise.
 
The educational background, technical ability and quantity of the inspectors should match the product inspection work. Inspectors should be familiar with relevant laws and regulations, standards and product technical requirements for medical devices, master the principles of inspection methods, test operation skills, work instructions, quality control requirements, laboratory safety and protection knowledge, measurement and data processing knowledge, etc., and should pass Training and assessment of medical device-related laws and regulations, quality management and related professional technology.
 
Inspectors, reviewers, approval personnel, etc. shall be authorized by the registration applicant in accordance with regulations.
 
2. Requirements for equipment and environmental facilities. The registration applicant should be equipped with equipment and environmental facilities that meet the requirements of the inspection method, establish and save the equipment and environmental facilities' files, operating procedures, measurement/calibration certificates, use and maintenance records, and carry out value traceability in accordance with relevant regulations.
 
For laboratories that carry out special professional inspections, such as biological evaluation, electromagnetic compatibility, biological safety laboratories, etc., their environmental facilities should meet their specific professional requirements.
 
3. Sample requirements. The registration applicant shall establish and implement inspection sample management procedures to ensure that the samples are controlled and maintained in a corresponding state.
 
4. Inspection quality control requirements. The registration applicant should be able to use appropriate methods and procedures to carry out all inspection activities. When appropriate, it includes the evaluation of measurement uncertainty and the use of statistical techniques for data analysis.
 
Encourage registered applicants to participate in related proficiency testing/interlaboratory comparison projects organized by proficiency testing institutions to improve testing capabilities and levels.
 
5. Recorded control requirements. All quality records, original inspection records, and relevant certificates/certificate copies and other technical records should be archived and kept for an appropriate period. Records include, but are not limited to, equipment usage records, original inspection records, purchase and acceptance records of raw and auxiliary materials for inspection, etc. The retention period of records should not be less than the requirements of relevant laws and regulations.
 
(3) Management system requirements
 
For the self-inspection carried out during registration, the registration applicant shall establish and implement a management system suitable for the self-inspection work in accordance with the requirements of the relevant inspection work and the self-inspection of the declared product.
 
The self-inspection work management system should be incorporated into the medical device production quality management system. Registration applicants should formulate quality management system documents related to self-inspection work, including policies, procedures, work instructions, etc., risk management of inspection work carried out and documents required by relevant medical device regulations, etc., and ensure their effective implementation and acceptance Control.
 
(4) Standards for self-inspection
 
The registration application shall conduct a full project inspection based on the product technical requirements of the products to be registered.
 
The formulation of inspection methods should be compatible with the corresponding performance indicators. Priority should be given to the use of promulgated standard inspection methods or recognized inspection methods.
 
The inspection method should be properly verified or confirmed to ensure that the inspection is repeatable and operability.
 
For in-vitro diagnostic reagent products, the test method should also clearly indicate the reference/standard product, the method of sample preparation, the batch and quantity of the reagent used, the number of tests, the calculation method, etc.
 
(5) Other
 
1. The applicant for registration of entrusted production can entrust the entrusted production enterprise to carry out self-inspection and issue a corresponding self-inspection report.
 
2. The domestic group company or its subsidiary has a laboratory accredited by the China National Accreditation Service for Conformity Assessment (CNAS), or the overseas group company or its subsidiary has a laboratory accredited by a foreign government or a corresponding laboratory accreditation agency accredited by the government If the group company or its subsidiary is authorized to carry out the self-inspection by the corresponding laboratory, the registration applicant shall issue the corresponding self-inspection report.
 
2. Self-inspection report requirements
 
(1) The self-inspection report submitted during the first registration should be a full-project inspection report that meets the technical requirements of the product.
 
For changes to registration and renewal of registration, corresponding inspection reports shall be submitted in accordance with relevant regulations. The report format should meet the requirements of the inspection report template (see Annex 1).
 
(2) The self-inspection report should have accurate conclusions, be easy to understand, use standard words, concise language, neat and clean, and no alteration is allowed. The signature and seal should meet the relevant requirements of "Medical Device Registration Application Data and Approval Document Format" and "In Vitro Diagnostic Reagent Registration Application Data and Approval Document Format".
 
(3) The inspection model, specification/packaging specification in the self-inspection report should cover other models in the registration unit.
 
3. Commissioned inspection requirements
 
(1) Commission conditions
 
If a registration applicant submits a self-inspection report, if he does not have the inspection capabilities for some of the provisions in the product technical requirements, he can entrust the relevant provisions to a qualified medical device inspection agency to conduct the entrusted inspection. Qualified medical device inspection institutions shall comply with the provisions of Article 75 of the Regulations on the Supervision and Administration of Medical Devices.
 
(2) Evaluation of the entrusted party
 
The applicant for registration shall evaluate the qualifications and conformity of inspection capabilities of the entrusted party in the medical device production quality management system documents, establish a directory of qualified entrusted parties, and keep the evaluation records and evaluation reports.
 
(3) Sample consistency
 
The registration applicant shall ensure that the self-inspected samples are consistent with the entrusted samples. Should communicate with the relevant entrusted party in a timely manner, report the problem, and assist in the relevant inspection work.
 
The registration applicant shall summarize the reports issued by the entrusted party and form a complete self-inspection report. For items involving commissioned inspection, the content can be filled in as shown in the corresponding commissioned inspection report, and the original commissioned inspection report shall be provided.
 
Four, application materials requirements
 
If the registration applicant submits the registration inspection report through self-inspection, the following application materials shall be submitted:
 
(1) Self-inspection report. If there are entrusted inspection items, the entrusted inspection agency shall be indicated and the qualification certification documents of the relevant inspection agency shall be provided.
 
(2) A statement of having the corresponding self-inspection capability. The registration applicant shall promise to have the ability to self-inspect the corresponding specific items in the product technical requirements, including the corresponding personnel, equipment, facilities and environment, and carry out the inspection in accordance with the requirements of the quality management system.
 
(3) Relevant materials of the quality management system. Configuration table of inspection equipment (including standard products/reference products) (Attachment 2); For the software used for medical device inspection, its name, release version number, release date, supplier or agent and other information should be specified (for format refer to Annex 2 ); Inspector Information Form (Annex 3); A list of inspection-related quality management system documents, such as quality manuals, procedure documents, work instructions, etc. The name of the document should include document number information, etc.
 
(4) Explanation about model coverage. Provide relevant data on model coverage, including typical descriptions, analysis of differences between the covered model/configuration and the main inspection model/configuration, and conformity evaluation, etc.
 
(5) Statement of self-guarantee for the authenticity of the report. If the registration applicant entrusts relevant items for inspection, the self-assurance statement should include a declaration of the consistency of the self-inspected samples and the entrusted inspection samples.
 
The self-inspection laboratory of the domestic registration applicant is accredited by the China National Accreditation Service for Conformity Assessment (CNAS), or the laboratory that the overseas registration applicant conducts the self-inspection is accredited by the foreign government or the corresponding laboratory qualification certification agency accredited by the government , It is not necessary to submit the contents of items (2) and (3) of this article, but the corresponding recognized supporting documents and supporting materials of the corresponding inspection scope shall be submitted. If the group company or its subsidiary is authorized by the group company to carry out the self-inspection by the corresponding laboratory, a letter of authorization shall be submitted.
 
V. On-site inspection requirements
 
For those submitting a self-inspection report, when conducting on-site inspections of the medical device registration quality management system, the drug regulatory authority shall, in addition to complying with the requirements of the relevant medical device registration quality management system verification guidelines, also conduct self-inspection capabilities and self-inspection status of the registration applicant. Verification focuses on inspection records, inspection quality control capabilities, inspectors' operating skills, inspectors' qualification requirements, facilities and environment, inspection instruments and equipment, etc.
 
(1) Inspection records: viewing original records, inspection equipment use, calibration, maintenance and repair records, inspection environmental conditions records, inspection sample effectiveness, audit evaluation records and reports on the entrusted party, entrusted inspection reports (if any), Entrusted inspection agreement (if any), etc.
 
(2) Quality control ability: check inspection-related quality manuals, procedure documents, standards, work instructions (if applicable), operating procedures, inspection method verification/confirmation records, internal quality control records and other documents.
 
(3) Operating skills of inspectors: conduct random inspections on items claimed to be self-inspected, and require the corresponding inspectors in the inspector information sheet to perform on-site operations on retained samples or self-inspected samples in accordance with the work instructions (or operating procedures). The entire inspection process can be repeated, the inspection methods meet the requirements, and the inspection results are consistent with the conclusions in the company's application and registration materials.
 
(4) Qualification requirements of inspectors: check the on-the-job certificate of inspectors, the training records of inspectors and approved personnel in the relevant personnel information table, personal files and other documents, and conduct face-to-face communication with the corresponding personnel to verify whether the qualifications and abilities meet the relevant quality management System requirements.
 
(5) Facilities and environment: laboratories that carry out special professional inspections, such as biological laboratories, electromagnetic compatibility laboratories, in vitro diagnostic reagent laboratories, etc., check whether the laboratory's facilities, environment, and monitoring records meet the requirements of product inspection .
 
(6) Inspection equipment: Check whether the information in the equipment configuration table for self-inspection submitted in the application materials is consistent with the relevant equipment on site. Check whether the verification/calibration records and measurement confirmation data of the inspection equipment meet the inspection requirements. Check the list of inspection equipment. The source of the equipment (self-purchased/long-term lease) should be indicated on the list, and the corresponding contract documents should be checked.
 
If you use enterprise-made calibrators, quality control products, sample processing reagents, etc., you should check the relevant operating procedures, quality standards, preparation and inspection records. Attention should be paid to calibrator preparation, value transfer procedures, uncertainty requirements, stability studies, etc. Pay attention to the preparation of quality control products, operating procedures for assignment, determination of target value range, stability research, etc.
 
If the domestic registration applicant’s self-inspection laboratory is accredited by the China National Accreditation Service for Conformity Assessment, or the overseas registration applicant’s self-inspection laboratory is accredited by a foreign government or a government-recognized laboratory certification body, it shall be registered as a medical device The quality management system verification guidelines require handling.
 
6. Responsibility requirements
 
Registration applicants should strengthen the quality management of the entire life cycle of medical devices in accordance with the requirements of the Regulations on the Supervision and Administration of Medical Devices, and be responsible for the safety and effectiveness of medical devices in the entire process of development, production, and inspection.
 
If the self-inspection report is false, it shall be punished in accordance with Article 83 of the Regulations on the Supervision and Administration of Medical Devices. If the entrusted party issues a false inspection report, it shall be punished in accordance with the 96th Regulations on the Supervision and Administration of Medical Devices.

 

【Source of the article】 State Food and Drug Administration

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