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2021-07-30

Fly inspection bright sword! 11 medical device companies in Jiangsu stopped production for rectification!

Policy Interpretation | "Notice on matters related to the registration of drug-device combination products"

2021-07-30

2021-06-10

Eight departments issued documents! All public hospitals join the centralized procurement of high-value consumables

Recently, the National Medical Insurance Bureau, the National Development and Reform Commission, the Ministry of Industry and Information Technology and other 8 departments jointly issued the "Guiding Opinions on the Centralized State-owned Organization for the Centralized Procurement and Use of High-Value Medical Consumables", which clearly requires **public medical institutions (including the military) Medical institutions) should participate in the centralized procurement of high-value medical consumables in accordance with regulations. Medical insurance designated social medical institutions can voluntarily participate in centralized procurement in accordance with the relevant regulations of their province (autonomous region, municipality).

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Eight departments issued documents! All public hospitals join the centralized procurement of high-value consumables

2021-06-02

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)"

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.

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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)"

2021-06-01

FORMAL ENFORCEMENT OF THE NEW REGULATIONS ON JUNE 1, ANY EFFECT ON APPLICATION FOR INNOVATIVE MEDICAL DEVICES?

The Regulations for the Supervision and Administration of Medical Devices (Revised Draft) was approved at the executive meeting of the State Council on December 21, 2020. The State Council officially promulgated the Regulations for the Supervision and Administration of Medical Devices (2021) on February 9, 2021. The formal enforcement on June 1 marks a new stage for the reform of medical device review and approval in China. 316 innovative program products were included, with 109 products approved. It is learned that in order to implement the national spirit of deepening reform and encouraging innovation, the Special Approval Procedures for Innovative Medical Devices (Trial) was formulated in February 2014; afterwards, in order to implement the Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation of Drugs and Medical Devices (TZ [2017] No. 42) issued by the General Office of the CPC Central Committee and the General Office of the State Council, encourage R&D innovations of medical devices, enhance the promotion and application of new technologies of medical devices, and promote the high-quality development of medical device industry, National Medical Products Administration (NMPA) organized to revise the Special Approval Procedures for Innovative Medical Devices in 2018. The Center for Medical Device Evaluation of the National Medical Products Administration (hereinafter referred to as the “CMDE”) acted as an implementing unit and cooperated with the Chinese Society of Biomedical Engineering and the Chinese Society for Biomaterials. With the help of the rich expert resources of the societies, authoritative experts and scholars in relevant research fields were selected to put forward review opinions. Statistically, the CMDE entrusted the two societies to organize and hold more than 520 expert review meetings on innovative medical devices during 2018-2020. Meanwhile, the CMDE established a joint review mechanism for the collective research on experts’ review opinions and relevant issues in the form of member working meeting jointly with the Department of Medical Device Registration and societies. As of May 26, 2021, the CMDE has received 1,554 applications for special review of innovative medical devices. 316 innovative program products were included, with 109 products approved. Improving the innovation system and introducing global latest medical technologies to China The Regulations for the Supervision and Administration of Medical Devices (2021) specified that China will develop plans and policies for medical device industry, include medical device innovation into development priorities, give priority to the review and approval of innovative medical devices, support the clinical promotion and use of innovative medical devices, and promote the high-quality development of medical device industry. The Drug Supervision and Administration Department of the State Council shall cooperate with the relevant departments of the State Council to implement the national planning and guidance policies for the medical device industry (Article 8). In the meantime, China will improve the medical device innovation system, and support the basic research and applied research of medical devices, as well as science and technology project approval, financing, credit, bid procurement, medical insurance and other aspects. Moreover, China will support enterprises establish or jointly establish R&D institutions, encourage enterprises to carry out medical device research and innovation in cooperation with institutions of higher learning, research institutes, medical institutions and so on, strengthen the protection of intellectual property rights of medical devices, and improve the capability of independent innovation in medical devices (Article 9). In addition, the Regulations for the Supervision and Administration of Medical Devices (2021) implemented effective reform measures to promote and encourage innovation carried out by the Regulations for the Supervision and Administration of Medical Devices in recent years. Such measures include: the implementation of the medical device MAH system to further reduce the burden on enterprises; giving commendation and rewards to units and individuals that have made outstanding contributions to the research and innovation of medical devices in accordance with the relevant national regulations (Article 12) to accelerate the transformation of scientific research and technological achievements in the medical field. It is worth mentioning that the Regulations for the Supervision and Administration of Medical Devices (2021) provided that, the registration of imported innovative medical devices will no longer require the certification documents issued by the competent authorities of the country (region) where the registrant to permit the marketing of the medical devices, encouraging the application of the latest global medical technologies in China. Following t

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FORMAL ENFORCEMENT OF THE NEW REGULATIONS ON JUNE 1, ANY EFFECT ON APPLICATION FOR INNOVATIVE MEDICAL DEVICES?

2021-05-31

NMPA Announcement on Implementing Relevant Matters of the Regulations for the Supervision and Administration of Medical Devices

The revised Regulations for the Supervision and Administration of Medical Devices (State Council Order No. 739, hereinafter referred to as the Regulations) will be implemented as of June 1, 2021. NMPA is organizing the formulation and revision of supporting regulations, normative documents and technical guidances, which will be released one after another in accordance with procedures. The matters related to implementation of the new Regulations are hereby announced as follows: I. Full Implementation of the Medical Device Registrant and Filing Applicant System As of June 1, 2021, the enterprises and the medical device R&D institutions, which have obtained the medical device registration certificate or have filed Class I medical devices, shall fulfill the obligations of medical device registrant and filling applicant respectively, strengthen the quality management over the whole life cycle of medical devices, and bear responsibilities for the safety and effectiveness of medical devices in the process of R&D, manufacture, distribution and use in accordance with the new Regulations. II. Registration and Filing of Medical Devices As of June 1, 2021, prior to the issuance and implementation of relevant provisions on registration and filing supporting the new Regulations, medical device registrants and filing applicants shall continue to apply for registration and conduct filing in accordance with the current provisions. The requirements for clinical evaluation of medical devices shall be implemented in accordance with Article III of this Announcement. Medical products administration shall carry out the registration and filing in accordance with the currently specified procedures and time limits. III. Clinical Evaluation Management of Medical Devices As of June 1, 2021, medical device registrants and filing applicants shall carry out clinical evaluation in accordance with the new Regulations. Clinical evaluation may be exempted for those complying with the provisions for exemption from clinical evaluation in the new Regulations; for the purpose of performing clinical evaluation, it is feasible to prove the safety and effectiveness of the medical device by carrying out clinical trials according to the product characteristics, clinical risks and the existing clinical data or by performing analysis and evaluation on the clinical literatures and clinical data of predicate medical devices; clinical trials shall be carried out for medical devices whose safety and effectiveness cannot be proved by the existing clinical literatures and clinical data. Prior to the issuance and implementation of relevant documents on exemption from clinical evaluation, the current Catalogue of Medical Devices Exempted from Clinical Trials shall be referenced for the Catalogue of Medical Devices Exempted from Clinical Evaluation. IV. Production Licensing and Filing Management of Medical Devices Prior to the issuance and implementation of relevant provisions on production licensing and filing supporting the new Regulations, medical device registrants and filing applicants shall handle the production licensing, filing and entrusted production in accordance with the existing rules and normative documents. V. Distribution Licensing and Filing Management of Medical Devices Medical device sold by its registrant and filing applicant at their residence or manufacturing site may not apply for medical device distribution licensing or filing, but shall comply with the specified distribution conditions; for Class II and Class III medical devices stored and sold at other sites, application for medical device distribution licensing or filing shall be made as required. NMPA has drafted a Catalogue of Class II Medical Devices Exempted from Distribution and Filing, for which public comments are currently solicited. After being issued, the Catalogue shall be executed. VI. Investigation and Punishment of Illegal Acts of Medical Devices Where an illegal act of medical device occurs before June 1, 2021, the Regulations before revision shall apply. However, if the act is not considered illegal or the punishment is relatively light according to the new Regulations, the new Regulationsshall apply. Where an illegal act occurs after June 1, 2021, the new Regulations shall apply. It is hereby announced.

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NMPA Announcement on Implementing Relevant Matters of the Regulations for the Supervision and Administration of Medical Devices

2021-05-08

NMPA Announcement on Issuing the Working Procedures for Dynamic Adjustment of Classification Catalogue for Medical Devices

In order to strengthen the classification management of medical devices and standardize the dynamic adjustment of the Classification Catalogue for Medical Devices, according to the Regulations for the Supervision and Administration of Medical Devices and the Classification Rules for Medical Devices, NMPA has organized to formulate the Working Procedures for Dynamic Adjustment of Classification Catalogue for Medical Devices, which was issued on April 27.

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NMPA Announcement on Issuing the Working Procedures for Dynamic Adjustment of Classification Catalogue for Medical Devices

2021-04-15

NMPA Announcement on Issuing 5 Technical Review Guidances for Registration

To strengthen the supervision and guidance of medical device registration and further improve the quality of registration review, NMPA has organized to formulate the Guidance for Package Insert Update and Technical Review of Oncology Companion Diagnostic Reagents Based on Similar Therapeutic Products, the Technical Review Guidance for the Registration of Real-time Fluorescence PCR Analyzer, the Technical Review Guidance for the Registration of Rotavirus Antigen Test Reagents, the Technical Review Guidance for the Registration of Group B Streptococcus Nucleic Acid Test Reagents, and the Technical Review Guidance for the Registration of Human Parvovirus B19 IgM/IgG Antibody Test Reagents, which were issued on April 7.

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NMPA Announcement on Issuing 5 Technical Review Guidances for Registration

2021-03-29

National Annual Report for Medical Device Adverse Event Monitoring (2020)

Overall Situation of National Annual Report for Medical Device Adverse Events

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National Annual Report for Medical Device Adverse Event Monitoring (2020)

2021-03-27

National Health Commission, March 23, 2021 (Tuesday) at 10 am: Anhui Elastic Bandage 00 will hold regular news about the "health" and "five one" service actions

The National Health Commission will hold a regular press conference on March 23, 2021 (Tuesday) at 10:00 am on the "Health" and "Five Ones" service actions. The medical insurance department formulates and adjusts the price of "Internet + medical service".

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National Health Commission, March 23, 2021 (Tuesday) at 10 am: Anhui Elastic Bandage 00 will hold regular news about the "health" and "five one" service actions

2021-03-27

The medical insurance agency and the physical medical institution that provide the connected Anhui elastic bandage network diagnosis and treatment conduct settlement

In terms of the “one-code access” of the health code, the informatization of Chinese medicine will be an important part of it. At present, more than 7,700 hospitals above the second level have established an appointment diagnosis and treatment system to realize that the external prescriptions issued by medical institutions that provide Internet diagnosis and treatment can be crossed.

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The medical insurance agency and the physical medical institution that provide the connected Anhui elastic bandage network diagnosis and treatment conduct settlement

2021-03-19

Evaluation Center Solicits Opinions: 22 second-class guiding principles for medical device registration technologies in 2020

ccording to the relevant requirements of the National Medical Products Administration's 2020 Medical Device Registration Guidelines Project Plan, our center has organized and compiled 22 Class II guidelines (Annex 1) including the "Technical Guidelines for the Registration of Net Nebulizers". A draft for soliciting opinions has been formed, and comments will be publicly solicited on the Internet from now on. If you have any comments and suggestions, please fill in the feedback form (Annex 2) and send it back to the corresponding contact person (Annex 3) before April 17, 2021.

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Evaluation Center Solicits Opinions: 22 second-class guiding principles for medical device registration technologies in 2020

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