On 8 April 2026 China’s National Center for ADR Monitoring issued the revised Guideline on Adverse Event Risk Evaluation for Device Registrants, followed on 10 April 2026 by a trial Guideline on the Review of Periodic Risk Evaluation Reports.
The revision introduces a more structured benefit-risk framework: after evaluating an individual adverse event, the registrant must also assess what that event does to the product’s overall benefit-risk balance, rather than treating it in isolation.
Submission requirements for the Periodic Risk Evaluation Report are tiered. Class II and Class III devices must submit online through the NMPA adverse-event reporting system. Class I devices compile a report annually for the first five years but submit only when the regulator asks.
In the same period NMPA issued five trial documents on device vigilance, applied across 17 pilot regions including Beijing, Shanghai and Guangdong.
Who in this database it affects
The tiered submission rule means 21,908 Chinese companies in this database holding Class II or III registrations must file periodic risk evaluation reports online through the NMPA system, while Class I filers submit on request. Cross-read by market at the by-market page.
How our data is verified
Every market figure on this site is the result of **re-checking each manufacturer name record by record**, not a raw hit count from a registry search interface. Name search in these registries is generally a substring match: searching EUDAMED for "Edan" returns 1,933 records, of which 434 belong to HANEDAN in Turkey and 300 to TeDan Surgical in the United States — taking the raw count would overstate by more than 60 percent. We therefore require the distinctive token to appear as a whole word and demand a genuinely distinguishing shared token; generic words such as "medical" or "systems" never qualify on their own, and the similar names that were excluded are listed on each company page. Each market counts a different unit (the EU counts UDI-DI device records, the US counts listed device types, Canada and Brazil count valid registrations, Korea counts quality-system certifications), so figures cannot be summed or compared across markets. The full basis, official portals and query paths are at the methodology page.
Related
Related: The 14 registries side by side · Chinese companies · Methodology and query paths · Data sources and licences.
China’s National Center for ADR Monitoring, published 8 and 10 April 2026