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Provisions for Supervision and Administration of Medical Device Manufacturing
2022-09-30
Promulgated by Decree No. 53 of the State Administration for Market Regulation on March 10, 2022, these Provisions shall be effective as of May 1, 2022.
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Provisions for Supervision and Administration of Medical Device Distribution
2022-09-30
Promulgated by Decree No. 54 of the State Administration for Market Regulation on March 10, 2022, these Provisions shall be effective as of May 1, 2022.
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NMPA Announcement on Two Guidelines for Registration Review of Drug-Device Combination Products with Device Taking Primary Mode of Action
2022-01-17
National Medical Products Administration has set the technical evaluation of drug-device combination products as a research project in regulatory science, and organized to formulate the Guideline for Registration Review Drug-Device Combination Products with Device Taking Primary Mode of Action and the Guideline for Registration Review of Qualitative, Quantitative and In Vitro Release Studies of Drugs in Drug-Device Combination Products with Device Taking Primary Mode of Action.
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NMPA Announcement on the Emergency Approval Procedure for Medical Devices
2021-12-29
National Medical Products Administration organized to revise the Emergency Approval Procedure for Medical Devices, which is issued and take effect as of December 29, 2021.
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NMPA Notice on Matters Concerning the Registration of Drug-device Combination Products
2021-07-27
In accordance with relevant provisions for registration management of drugs and medical devices, matters concerning the registration of drug-device combination products are hereby announced on July 23 as follows.
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NMPA Announcement on Issuing 6 Guidance including the Guidance for Nomenclature of the Generic Names of Medical Rehabilitation Devices
2021-07-15
The NMPA has organized to formulate the 6 Guidance including the Guidance for Nomenclature of the Generic Names of Medical Rehabilitation Devices, which are issued on July 12.
