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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.
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NMPA Announcement on Issuing the Catalogue of Distribution of Class II Medical Devices Exempted from Filing
2021-06-30
In order to implement the Regulations on the Supervision and Administration of Medical Devices, the NMPA organized to formulate the Catalogue of Distribution of Class II Medical Devices Exempted from Filing, which was issued on June 28.
