NMPA Updated Medical Device Quality Audit Management Measures
On March 13, 2020, NMPA updated the new regulation: Measures for the Management of Medical Device Quality Audit. Meanwhile, the Administrative Regulations on Quality Supervision and Audit of Medical Devices (食药监械监[2013] No. 212) and the National Medical Device Audit Work Procedure (食药监械监[2014] No. 213) issued by NMPA shall be abolished. The new regulations include seven chapters: general rules, protocols, audit sampling, audit management and report delivery, re-inspection and disposal, surveillance and management, and supplementary provisions. China is enhancing the post-market surveillance since the latest two years. Bradynuoen as a qualified legal agent of overseas manufacturer can help the communication with NMPA, handle AE, recall, inspection etc.
