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) Monthly Newsletters
NMPA (CFDA) English Regulations
Downloadable Resources
What's New
| File # | Name | Phase | Issued By | Issued Date | Download |
|---|
| Decree 29, NMPA, 2018 | Measures for the Administration of Medical Device Recall | Implemented | CFDA | March 26, 2020 | Download |
| Decree 1 Annex 9, NMPA, 2018 | Guidance on Inspecting Medical Device Adverse Event Monitoring Activity | Draft | NMPA | March 26, 2020 | Download |
| Decree 1 Annex 7, NMPA, 2018 | Guidance on Focus Points when Monitoring Medical Device Adverse Events | Draft | NMPA | March 26, 2020 | Download |
| Decree 1 Annex 5, NMPA, 2018 | Guidance for License Holder on Collecting and Reporting Individual Cases of Medical Device Adverse Event | Draft | NMPA | March 26, 2020 | Download |
| Decree 1 Annex 3, NMPA, 2018 | Guidance on Medical Device Adverse Event Monitoring Scope | Draft | NMPA | March 26, 2020 | Download |
| Decree 1 Annex 1, NMPA, 2018 | Guidance on Medical Device Adverse Event Monitoring | Draft | NMPA | March 26, 2020 | Download |