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China: NMPA's 3 Important Announcements Regarding MDs Prohibited from Contract Manufacturing, Quality Agreements of Contract Manufacturing, and the Implementation of Measures for the Supervision of Production and Operation – June 2022

China: NMPA's 3 Important Announcements Regarding MDs Prohibited from Contract Manufacturing, Quality Agreements of Contract Manufacturing, and the Implementation of Measures for the Supervision of Production and Operation – June 2022

  • 2022-06-29 01:53:45

NMPA has made 3 important announcements on issuing the List of Medical Devices Prohibited from Contract Manufacturing (No. 17 of 2022), the Quality Agreements of Contract Manufacturing Medical Devices (No. 20, 2022), and on Matters Concerning the Implementation of the <Measures for the Supervision and Administration of the Production of Medical Devices> and the <Measures for the Supervision and Administration of the Operation of Medical Devices> (No. 18 of 2022), which have been summarized in our article below.

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China: Announcement on the Issuance of Guidelines for the Preparation of Annual Self-Inspection Reports of the Medical Device Quality Management System (No. 13 of 2022) – May, 2022

China: Announcement on the Issuance of Guidelines for the Preparation of Annual Self-Inspection Reports of the Medical Device Quality Management System (No. 13 of 2022) – May, 2022

  • 2022-05-26 13:11:53

NMPA has organized and revised the “Guidelines for the Compilation of the Annual Self-Inspection Report of Medical Device Quality Management System”, which has been promulgated and shall come into force on May 1, 2022. The Guidelines for the Compiling of the Annual Self-Inspection Report of Quality Management System of Medical Device Manufacturers issued by NMPA (No. 76 of 2016) previously shall be abolished at the same time.

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China: Guidelines for Medical Device Cybersecurity, Medical Device Software, and AI Medical Device Registration  (Revised Edition 2022)

China: Guidelines for Medical Device Cybersecurity, Medical Device Software, and AI Medical Device Registration (Revised Edition 2022)

  • 2022-04-27 11:16:17

NMPA has released a series of updated guidelines, which aim to guide registration applicants to prepare for medical device software and AI medical device registration in China. The 3 new guidelines regulate the technical reviewing requirements of medical device software and AI medical devices, while also elaborating on standardizing the cyber-security for medical devices.

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China: Two Guidelines for Registration and Review of Drug-Device Combination Products Mainly Functioning as Medical Devices – February, 2022

China: Two Guidelines for Registration and Review of Drug-Device Combination Products Mainly Functioning as Medical Devices – February, 2022

  • 2022-02-18 08:10:07

Drug-device combination products that mainly function as medical devices (referred to as drug-device combination medical devices in this guideline) are expected to make prevention and treatment of diseases more effective, but may also lead to new technical concerns. Therefore, NMPA formulated two guiding principles to further guide the applicant's preparation for the registration application for drug-device combination medical devices, and to encourage the innovative development of such products.

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