Regulatory Intelligence Portal

Resource Libraries

These Informative, complementary resource libraries are designed for medtech professionals to get unlimited access to China NMPA (CFDA) Monthly Newsletters, English translated NMPA (CFDA) Regulations, Webinars and other downloadable resources.

NMPA (CFDA) Newsletters

NMPA (CFDA) Regulations

Brochures & White Papers

Recorded Webinars

What's New

File #NamePhaseIssued ByIssued DateDownload
Current China NMPA Clinical Pathways for Medical Device RegistrationNovember 18, 2020Download
Overview of ART Products in ChinaSeptember 21, 2020Download
Drug-Medical Device Combination Products in ChinaSeptember 21, 2020Download
NMPA Medical Device Registration & Clinical Trial ProcessJuly 8, 2020Download
Notice No.7, CMDE, 2019Guideline on AI-Aided SoftwareImplementedCMDEJuly 3, 2019Download
Notice, CMDE-20190103Operation Specification for Record Filing of Medical Device Master FilesDraftCMDEJanuary 3, 2019Download