Strengthen Surveillance of Sterile and Implantable Medical Devices

On April 14, 2020, NMPA released a notice of strengthening surveillance of sterile and implantable medical devices from four aspects: inspection objects, inspection key points, inspection method and work requirements. Especially for the inspection key points of the manufacturing, circulation and application processes are clearly specified in this notice. Since China NMPA enhances the post-market surveillance, Bradynuoen can help manufacturers review the relevant process in compliance to China regulations.

Link: http://www.nmpa.gov.cn/WS04/CL2197/376486.html