When do the new NMPA medical device GMP inspection rules take effect?
November 1, 2026. From that date, production-license verification and post-market inspections run under the revised GMP and the new Inspection Guidance Principles (Notice No. 14 [2026]), replacing the 2015 on-site inspection principles.
Which medical device applications switch to the revised GMP automatically on November 1, 2026?
License, license-change, and renewal applications accepted but not yet inspected on-site, applications inspected but pending rectification, and Class I production filings not yet inspected. Class I filings must be inspected within three months of filing.
Do sterile, implantable, IVD, custom denture, or standalone-software devices have extra requirements?
Yes. From November 1, 2026, these five categories must meet both the revised GMP and the corresponding current GMP appendix. NMPA will publish appendix-specific inspection guidance separately.
Who must comply with the revised NMPA medical device GMP?
All medical device manufacturers holding or seeking a production license in China, including foreign manufacturers selling into the mainland market, plus Class I device filers subject to post-filing on-site inspection.
