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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) Monthly Newsletters

NMPA (CFDA) English Regulations

Downloadable Resources

What's New

File #NamePhaseIssued ByIssued DateDownload
Decree 29, NMPA, 2018Measures for the Administration of Medical Device RecallImplementedCFDAMarch 26, 2020Download
Decree 1 Annex 9, NMPA, 2018Guidance on Inspecting Medical Device Adverse Event Monitoring ActivityDraftNMPAMarch 26, 2020Download
Decree 1 Annex 7, NMPA, 2018Guidance on Focus Points when Monitoring Medical Device Adverse EventsDraftNMPAMarch 26, 2020Download
Decree 1 Annex 5, NMPA, 2018Guidance for License Holder on Collecting and Reporting Individual Cases of Medical Device Adverse EventDraftNMPAMarch 26, 2020Download
Decree 1 Annex 3, NMPA, 2018Guidance on Medical Device Adverse Event Monitoring ScopeDraftNMPAMarch 26, 2020Download
Decree 1 Annex 1, NMPA, 2018Guidance on Medical Device Adverse Event MonitoringDraftNMPAMarch 26, 2020Download