-
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.
-
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.
-
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.
-
NMPA Announcement on Issuing 2 Guidance including the Technical Review Guidance for the Registration of Vision Screeners and Mammography Systems
2021-06-29
The NMPA organized to formulation of the Guidelines for Technical Review of Vision Screener Registration and the Guidelines for Technical Review of Mammography System Registration, which were published on June 24.
-
NMPA Announcement on Implementing Relevant Matters of the Regulations for the Supervision and Administration of Medical Devices
2021-05-31
The revised Regulations for the Supervision and Administration of Medical Devices will be implemented as of June 1, 2021.
-
NMPA Announcement on Approving the Registration of 139 Medical Devices
2021-05-24
In April 2021, NMPA approved the registration of a total of 139 medical devices. Among them, there are 100 domestic Class III medical devices, 19 imported Class III medical devices, 19 imported Class II medical devices, and 1 medical device from Hong Kong, Macao and Taiwan.
