On September 15, 2026, China's National Medical Products Administration (NMPA) issued Notice No. 14 [2026] (国药监械管〔2026〕14号), publishing the Inspection Guidance Principles for the Medical Device Good Manufacturing Practice (医疗器械生产质量管理规范检查指导原则). The guidance operationalizes the newly revised Medical Device GMP, which takes effect on November 1, 2026, and supersedes the 2015 on-site inspection principles (食药监械监〔2015〕218号) that inspectors have applied for a decade.
For manufacturers selling into China, the consequence is direct: from November 1, 2026, drug supervision departments must run both production-license verification audits and post-market surveillance inspections strictly under the revised GMP, and judge and dispose of findings against the new Inspection Guidance Principles. The notice is published on the NMPA regulatory documents page for medical devices.
What changes for production-license and post-market inspections from November 1?
The revised GMP becomes the sole benchmark for two inspection streams. First, production-license verification (生产许可核查): applications for a new license, a license change, or a license renewal are assessed on-site against the revised GMP, with the Inspection Guidance Principles defining how deficiencies are classified and how disposal decisions are reached. Second, post-market supervision inspections (上市后监督检查): provincial drug administration bureaus must conduct these under the new GMP rather than the prior regime.
Until October 31, 2026, inspectors continue applying the current GMP for license verification, but they already reference the new Inspection Guidance Principles to assess how ready a manufacturer is for the revised standard and to issue rectification recommendations. This dual window lets firms surface gaps before the switchover, but it does not move the November 1 deadline.
Which applications flip to the revised GMP during the transition?
The notice draws a hard line at November 1, 2026 for in-flight applications. Three scenarios cross over automatically:
| Application state before November 1, 2026 | Treatment from November 1 |
|---|---|
| License, license change, or renewal accepted but not yet inspected on-site | Inspection runs under the revised GMP |
| Inspected, but no licensing decision because the firm has not finished rectification | Re-assessment and decision under the revised GMP |
| Class I device production filing (备案) not yet inspected on-site | On-site inspection under the revised GMP |
For Class I device filers, the supervision department must complete the on-site inspection within three months of receiving the filing materials, checking both the submitted documents and GMP compliance. Filings made before November 1 that have not yet been inspected will be inspected under the revised GMP from that date.
What must manufacturers of sterile, implantable, IVD and software devices do?
Five special product categories carry an additional obligation: sterile devices, implantable devices, in vitro diagnostic reagents, custom dentures, and standalone software medical devices. From November 1, 2026, their production quality management must satisfy both the revised GMP and the corresponding current GMP appendix for that product type.
NMPA will revise and publish the inspection guidance principles specific to these appendices separately, so manufacturers in these categories should track the appendix revisions closely and not assume the general principles alone cover their audit.
How should compliance leads prepare for risk-based full-coverage inspections?
Provincial drug administration bureaus are directed to build risk-based post-market inspection plans keyed to the risk level of both the product and the manufacturer, then roll out phased, full-coverage inspections against the revised GMP. Full coverage signals intent to reach every in-scope manufacturer over the plan's horizon, not a one-time sweep, so firms should expect recurring, risk-tiered audits rather than a single event.
Continuous, per-jurisdiction real-time monitoring surfaces a change like this the moment it publishes, which is why Obsidian tracks NMPA device notices as they land rather than at the next quarterly review.
Subscribe to the free newsletter
Before November 1, 2026, confirm whether your products fall in a special category that must also meet a GMP appendix, map your quality system gaps against the revised GMP, and brief your regulatory affairs and quality teams on the transition rules for any in-flight license application. For pending Class I filings, plan for an on-site inspection within three months.
