NMPA Issues Inspection Guidelines for Newly Revised Medical Device Production Quality Management Regulations
China's National Medical Products Administration (NMPA) has issued a notice to provincial-level drug regulatory authorities across the country, including those in autonomous regions, municipalities, and the Xinjiang Production and Construction Corps, announcing the release of the "Inspection Guiding Principles for Medical Device Production Quality Management Regulations" (hereinafter "Inspection Guidelines"). The move comes ahead of the implementation of the newly revised "Medical Device Production Quality Management Regulations" (GMP), which will take effect on November 1, 2026.
Background
To provide regulatory authorities at all levels with clearer direction for conducting medical device production inspections, NMPA organized a revision of the 2015 "On-site Inspection Guiding Principles for Medical Device Production Quality Management Regulations" (Document No. [2015] 218), resulting in the newly published Inspection Guidelines.
Key Provisions
The notice outlines five major implementation requirements:
1. Full Implementation from November 1, 2026
Starting on this date, drug regulatory authorities must strictly apply the newly revised GMP when conducting production license inspections and post-market supervisory checks, with judgments and enforcement actions determined according to the new Inspection Guidelines.
2. Transition Arrangements
Before November 1, 2026, authorities will continue inspections under the current GMP, while simultaneously referencing the new Inspection Guidelines to assess enterprises' readiness for the revised regulations and offer rectification recommendations. For production license applications, license modifications, or renewal requests accepted before November 1 but not yet inspected on-site—or inspected but pending a decision due to incomplete corrective actions—review will shift to the new GMP standard starting November 1.
3. Class I Device Filing Inspections
Following a Class I medical device production filing, regulatory authorities must conduct an on-site inspection of submitted materials and GMP compliance within three months. Filings made before November 1, 2026 that have not yet undergone inspection will also be evaluated under the new regulations from that date onward.
4. Risk-Based Post-Market Surveillance
Provincial drug regulatory authorities are required to develop post-market inspection plans based on the risk levels of products and enterprises, working toward phased, full-coverage inspections aligned with the new GMP. Authorities must take effective measures to ensure enterprises achieve compliance within the specified timeframe and maintain ongoing quality management system integrity.
5. Special Categories
From November 1, 2026, production quality management for sterile devices, implantable devices, in vitro diagnostic reagents, custom-made dentures, and standalone software medical devices must comply with both the newly revised GMP and the corresponding appendices of the current regulations. Inspection guidelines specific to these categories will be revised and issued separately.
Effective Date and Repeal
The new Inspection Guidelines will take effect on November 1, 2026, at which point the original 2015 guidelines issued by the former China Food and Drug Administration will be officially repealed.
The notice was signed by NMPA and dated September 14, 2026.