On 2 February 2026 the FDA replaced the long-standing Quality System Regulation (QSR, 21 CFR 820) with the Quality Management System Regulation (QMSR), which incorporates ISO 13485:2016 by reference.

For Chinese exporters already running an ISO 13485 system this removes the cost of maintaining two parallel systems. But incorporation is not equivalence: 21 CFR 820 keeps FDA-specific record and labelling requirements, so an ISO 13485 certificate on its own does not demonstrate QMSR compliance.

In parallel, after 2 February 2026 the FDA no longer uses the Inspection of Medical Device Manufacturers (7382.845) and Medical Device PMA Pre-approval/Post-market Inspections (7383.001) programme documents.

What it actually means for Chinese exporters

Three distinctions matter. First, an ISO 13485 certificate is not by itself proof of QMSR compliance: while 21 CFR 820 now incorporates ISO 13485, it retains FDA-specific record, labelling and device master record requirements, so system documentation needs mapping rather than replacement. Second, the inspection approach changed — with the two former inspection programme documents retired, FDA uses a method closer to an ISO 13485 audit, and internal audit evidence should follow. Third, the date has passed: it took effect on 2 February 2026, so this is an execution period, not a preparation period.

Who in this database it affects

5,817 Chinese companies in this database have listed device types or 510(k)/PMA records with the US FDA; they are the ones directly affected by the QMSR transition. Full US picture: 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.

US FDA, amendment to 21 CFR 820, effective 2 February 2026