NMPA Publishes 6 Regulatory Drafts Concerning Clinical Trials for Medical Devices and IVDs

On May 10, 2021, the NMPA (National Medical Products Administration) published 6 regulatory draft documents concerning clinical trials for medical devices and IVDs:

• Medical device clinical trial protocol template (Draft)
• Medical device clinical trial report template (Draft)
• In vitro diagnostic reagent clinical trial protocol template (Draft)
• In vitro diagnostic reagent clinical trial report template (Draft)
• Sample report form for serious adverse events in clinical trials of medical devices/in vitro diagnostic reagents (Draft)
• Basic catalogue documents for clinical trials of medical devices (Draft)

The NMPA is currently soliciting public comments on the draft documents. The public consultation period is open until May 30, 2021.

Highlights

• Covers the unified clinical trial test protocols and report format of IVD reagents
• Heavily focuses on the procedures and requirements for reporting adverse events during clinical trials
• Formulate a standardized directory using the data traceability of clinical trials
• Identify items for improvements and blind spots from previous clinical trials, and propose actions to improve

By Jacky Li and Colleen Xu. Contact Cisema if you would like to learn more.