China's National Medical Products Administration (NMPA, 国家药品监督管理局) published Notice No. 16 of 2026 (国药监械管〔2026〕16号) on October 28, 2026. The notice, signed on October 23, 2026, issues four inspection guidelines under the revised Medical Device Good Manufacturing Practice (医疗器械生产质量管理规范) for sterile devices, implantable devices, in vitro diagnostic reagents and custom dentures, and states that those guidelines apply from November 1, 2026.
China registrants of sterile medical devices, China registrants of implantable medical devices, IVD reagent registrants supplying the China market, contract manufacturers of sterile, implantable and IVD devices produced for China, and custom denture manufacturers producing for the China market must map production and quality records to the new critical, major and general inspection items by November 1, 2026, or a production-licence verification or post-market supervision inspection that fails the new principles is judged non-conforming. On the same day the NMPA repeals the 2015 on-site guidelines for sterile, implantable and IVD devices (食药监械监〔2015〕218号) and the 2016 on-site guideline for custom dentures (食药监械监〔2016〕165号).
What do the four guidelines change on November 1, 2026?
From November 1, 2026, provincial medical products administrations judge production-licence verifications and post-market supervision inspections of these four categories against the new guidelines, not the 2015 and 2016 on-site texts. Each guideline converts the revised GMP and the matching appendix into scored inspection items at three levels: critical (***), major (**) and general (*). Result types and how a result is determined follow the separate Medical Device GMP Inspection Guidelines (医疗器械生产质量管理规范检查指导原则), which each category document names as the scoring rule.
| Guideline | Items | Critical | Major | General | Text |
|---|---|---|---|---|---|
| Sterile devices | 216 | 41 | 95 | 80 | Annex 1 |
| Implantable devices | 220 | 43 | 97 | 80 | Annex 2 |
| IVD reagents | 212 | 42 | 93 | 77 | Annex 3 |
| Custom dentures | 190 | 38 | 88 | 64 | Annex 4 |
The sterile, implant and denture texts address the registrant (注册人) and the entrusted manufacturer (受托生产企业). The IVD text also addresses the filer (备案人). Items run from the quality system and risk management through personnel, plant, equipment, design, purchasing, production, inspection, release, storage and contracted work, each tied to a clause of the GMP or of the category appendix.
Who is inspected under Notice No. 16 of 2026?
The exposed actors are the registrants and contract manufacturers whose sterile devices, implants, IVD reagents or custom dentures are produced for the China market, including foreign registrants that entrust production in China. The notice is addressed to the drug administrations of every province, autonomous region, municipality and the Xinjiang Production and Construction Corps: those authorities run the licence checks and the post-market inspections. A site that does not manufacture one of the four categories is outside these four checklists. The revised GMP itself still applies to device production more broadly from November 1, 2026. Notice No. 16 of 2026 is the category scoring layer for these four product families only.
What must the quality file show by November 1, 2026?
Before a licence verification or a post-market inspection on or after November 1, 2026, the quality file for each covered site should be mapped item by item to the annex that matches the product.
- Mark each critical, major and general item in the matching annex as met, gap or not applicable, with the record that shows it.
- Confirm that contracted design, production, outsourced processing and contracted testing sit inside the quality system, which the opening critical items of each annex require.
- For IVD reagents, include the filer as well as the registrant and the entrusted manufacturer, because Annex 3 names all three.
- Retire internal checklists copied from 食药监械监〔2015〕218号 and 食药监械监〔2016〕165号. Those texts are repealed on November 1, 2026.
- Align the way nonconformities are graded with the general Medical Device GMP Inspection Guidelines, which these four documents say govern result determination.
Continuous, per-jurisdiction monitoring is what surfaces a checklist of this kind on the day the NMPA publishes it, so a licence file is not still built on a repealed on-site text.
What is the result if an inspection fails the new items?
From November 1, 2026, a production-licence verification or a post-market supervision inspection that does not meet the new principles is judged non-conforming. The notice does not set a separate fine schedule. It states the judgment rule and the repeal of the earlier on-site guidelines. The enforcing bodies named in the notice are the drug regulatory departments that carry out those checks, under the NMPA. There is no extra transition date in Notice No. 16 of 2026: the guidelines, the judgment rule and the repeal take effect together on November 1, 2026.
Next, confirm which of the four annexes covers each China production site, finish the item map before November 1, 2026, and brief the quality and regulatory leads who host provincial inspectors. Obsidian tracks the NMPA device-GMP inspection texts as they are issued, so the next category checklist is visible when it is published.
