In order to do well in the implementation of the new regulation, NMPA issues the Announcement on Matters Concerning the Implementation of the "Quality Management Practice for Clinical Trials of Medical Devices" (No. 21 of 2022).

1. Thus, from 1 May 2022, clinical trials of medical devices that have not yet passed the ethical review shall be conducted after adjustment in accordance with the Practice. While for those that have passed the first ethical review, the work may be carried out in accordance with the requirements of the original relevant documents.

2. Attachments:
- Medical Device Clinical Trial Protocol Template
- Medical Device Clinical Trial Report Template
- IVD Reagent Clinical Trial Protocol Template
- IVD Reagent Clinical Trial Report Template
- Medical Device/IVD Reagent Clinical Trial Serious Adverse Event Report Form Template
- Catalogue of Basic Documents for Clinical Trials of Medical Devices/IVD Reagents

 

 

Reference:
Announcement of NMPA and the National Health and Health Commission on Issuing the "Quality Management Practice for Clinical Trials of Medical Devices" (No. 28 of 2022)
Announcement of NMPA on Matters Concerning the Implementation of the "Quality Management Practice for Clinical Trials of Medical Devices" (No. 21 of 2022)

分享: