Two things were frequently conflated in the first half of 2026. What received a full overhaul was the Regulations for the Implementation of the Drug Administration Law — published 16 January 2026, effective 15 May 2026, nine chapters and 89 articles, the first comprehensive revision in twenty-three years.
There is no 2026 edition of the Regulations on the Supervision and Administration of Medical Devices. They remain State Council Decree No. 739 (2021). The most recent change came from the State Council decision of 22 November 2024 amending and repealing certain administrative regulations, effective 20 January 2025.
What actually landed on the device side in 2026 sits at the level of departmental rules and guidance: the revised GMP effective 1 November 2026, the two April 2026 post-market guidelines, the classification and naming guidance for brain-computer interface devices (Notice No. 24 of 2026), and the procedure for dynamic adjustment of the device classification catalogue (Announcement No. 53 of 2026).
Who in this database it affects
Distinguishing the tiers matters when verifying: the Regulations are administrative law, while GMP and guidance documents are departmental rules and technical documents, with different force and revision cadence. This database records data sources and query paths, not the legal text — official portals are at the methodology page, and Chinese companies at the China 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.
State Council decree: the Regulations for the Implementation of the Drug Administration Law were published 16 January 2026 and took effect 15 May 2026; the Regulations on the Supervision and Administration of Medical Devices remain State Council Decree No. 739