NMPA Updated Guidelines On Software, Cybersecurity And AI

On March 7, 2022, NMPA published the updated Registration Review Guidelines on Medical Device Cybersecurity (Revision 2022), Registration Review Guidelines on AI Medical Device (No. 8, 2022),and Registration Review Guidelines on Medical Device Software (Revision 2022).

As per BradyKnows experience, China is encouraging digital health, as medical devices are developing more mature and many manufacturers upgrading software function on the product for better performance. On March 13, Hainan local government also released a notice to collect the innovative digital therapy product information and encourage the entry of Hainan Lecheng Medical Pilot Zone first with real world study.

We have given a workshop on digital health several months ago, and will hold another webinar for software, cybersecurity and AI medical devices next month. Please feel free to let us know any questions about digital health via info@bradyknowsmedical.com