On February 11, 2022, National Medical Products Administration (NMPA) released Notice on Issuing Inspection Work Procedure for Domestic Class III Medical Device Registration Quality Management System.
The Inspection Work Procedure for Domestic Class III Medical Device Registration Quality Management System (hereinafter referred to as the “Document”) is announced to be effective immediately. It mainly specifies:
- responsibilities of NMPA and provincial authorities
- inspection key points
- procedure and timelines
- personnel responsibilities
- inspection results
The Document is developed based on relevant regulations and laws mainly including:
- Regulation on the Supervision and Administration of Medical Devices (come into effect on June 1, 2021)
- Measures for the Administration of Registration and Recordation of Medical Devices (come into effect on October 1, 2021)
- Measures for the Administration of Registration and Recordation of In-Vitro Diagnostic Reagents (come into effect on October 1, 2021)
With the effectiveness of this updated version, the previous interim version of the Document will become invalid.
If you need more information on the topic, please contact: