Key Updates from NMPA

1. NMPA has revised the list of medical devices prohibited from contract manufacturing. This revision will take effect on May 1, 2022, and the previous CFDA announcement regarding the prohibited devices (no. 18 of 2014) will be repealed.

2. To strengthen the supervision of medical device production, ensure safety and effectiveness, and guide registrants and contract manufacturers in maintaining quality management, NMPA has issued guidelines for Quality Agreements in Contract Manufacturing of Medical Devices.

3.1 As of May 1, 2022, the Measures for the Supervision and Administration of the Operation of Medical Devices and the Measures for the Supervision and Administration of the Production of Medical Devices will come into force. Applications for licenses to produce and operate medical devices submitted before this date, which have not yet received approval, will be processed under the new measures.

3.2 From May 1, 2022, the previous CFDA announcements regarding the implementation of the Measures for the Supervision and Administration of the Medical Devices Production and the Measures for the Supervision and Administration of the Medical Devices Operation (No. 143[2014] of CFDA) will be repealed.

Regulatory Link Reference:

Regulatory Link - https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20220324101855146.html