National Medical Device Quality Audit Procedure (draft)

2020-10-19

On October 13, 2020, CMDE announced its preparation of National Medical Device Quality Audit Procedure (draft). This Procedure includes the following steps: protocol formulation, implementation and sampling, audit, re-audit, audit result release, objection and appeal, data analysis, and audit result processing. All kinds of opinions are welcome to be filled in the information collection form and submit it to CMDE before November 12, 2020 via email.

Link: https://www.nmpa.gov.cn/xxgk/zhqyj/zhqyjylqx/20201013161825188.html