NMPA Strengthening The Supervision And Management Of Medical Device Registration

In 2021, NMPA continues to strengthen the supervision and management of medical device registration.

• Class I filing surveillance

NMPA focused on class I filing surveillance of medical cooling pad. NMPA and local NMPA assigned six teams to do audit in 11 provinces. NMPA will continue to do audit on post-market surveillance in 2022.

• Clinical trial management

NMPA strengthens the surveillance of clinical trial sites and projects. During an audit on an IVD clinical trial of a Guangzhou company, NMPA found the issue of clinical trial data unable to be traceable, resulting in punishment as pe regulations.

BradyKnows has experienced some clinical trial audit by NMPA and local NMPA. NMPA has a guideline to audit clinical trial, and the authenticity and traceability are the two key points. Please feel free to reach out to Brady team for any questions during NMPA audit at info@bradyknowsmedical.com