Monthly NMPA (CFDA) News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China.
China New GCP Announced
NMPA published “Medical Device Clinical Trial Quality Management Measures (draft)” on May 7. It has the major impacts on responsibilities of the relevant parties in clinical trials, safety information reporting process, optimization requirements as well as the IVD sector which was not covered in the previous version. To see the major differences to the previous GCP, released in 2016, please click HERE
Seven Clinical Guidelines Published:
The NMPA issued seven draft guidelines to regulate the clinical pathways in May. Feedback needs to be submitted to the NMPA by May 30, 2021. They provide guidance to a wide range of clinical ways, from clinical trial, clinical exemption, to evaluation report and same-variety comparison. For our comprehensive review please click HERE
Draft Guideline “Artificial Intelligence Medical Software Classification” Asks Feedback
The NMPA is now seeking comments to the draft guideline “Artificial Intelligence Medical Software Classification”. It classifies four applications in medical-related fields based on products’ intended use, which are decision support software, image/data processing software, analysis and mining products and medical assistant products. Click HERE for more information
NMPA Standards Revisions Plan: 77 Standards to be Issued 2021
NMPA published the “2021 Medical Device Industry Standards Revisions Plan (draft)” on May 26, in which 77 medical devices and IVDs are affected. The plan includes manufacturing methods, performance testing standards, biological evaluation, non-clinical standards and quality systems of the 77 medical devices and IVDs.
The plan lists 70 industry recommended standards and seven industry mandatory standards; five of the mandatory are related to the Covid prevention and treatment. For the full list please click HERE
Medtronic, along with Three Domestic Device Makers, Proceeds to Fast-track Review
CMDE granted innovation and priority review status to four manufacturers in May, by which they can begin the fast-track application process. Click HERE for the full list.