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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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CHINA: Medical Device Clinical Trial Data Submission Requirements for Registration Review Guidelines-No. 91 in 2021 – January, 2022

CHINA: Medical Device Clinical Trial Data Submission Requirements for Registration Review Guidelines-No. 91 in 2021 – January, 2022

  • 2022-01-26 08:31:11

Clinical trial data is one of the important supporting documents for evaluating the safety and effectiveness of medical devices. Standardizing the collection, sorting, analysis, and submission of medical device clinical trial data will not only improve the quality of clinical trial implementation and management but also assist the regulatory agency to understand and review the development of clinical trials quickly and efficiently.

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HONG KONG:  MDD Continues Trial to Accept Marketing Approval from NMPA China and MFDS Korea for Listing Application of Medical Devices in Hong Kong – August, 2021

HONG KONG: MDD Continues Trial to Accept Marketing Approval from NMPA China and MFDS Korea for Listing Application of Medical Devices in Hong Kong – August, 2021

  • 2021-08-30 01:11:33

The Medical Device Division (MDD) will continue the trial to study the feasibility for Local Responsible Persons (LRP) to prove their medical device conform the “Essential Principles of Safety and Performance of Medical Devices” by providing marketing approval from China's National Medical Products Administration (NMPA) and Korea's Ministry of Food and Drug Safety (MFDS).

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