China’s National Medical Products Administration (NMPA) has issued new inspection guidelines for medical device manufacturers (Notice No. 14 of 2026, dated September 17). These guidelines come ahead of the revised Good Manufacturing Practice (GMP) for medical devices, which takes effect on November 1, 2026. On that date, the new guidelines replace the 2015 on-site inspection guidelines issued by the former China Food and Drug Administration (CFDA). From then on, provincial regulators will use the new guidelines for both manufacturing license inspections and post-market checks.
Until November 1, inspectors will keep applying the current GMP. In the meantime, they will use the new guidelines to gauge how prepared companies are and to recommend fixes. Any license application, amendment, or renewal that is still pending on that date will be reviewed under the revised GMP. This covers applications that have not had an on-site inspection yet, as well as those held up by unfinished corrective actions. The same applies to Class I manufacturing filings that have not been inspected. Regulators must inspect those within three months of filing
Provincial authorities must also draw up risk-based post-market inspection plans and work in phases toward inspecting every manufacturer against the revised GMP. Manufacturers of sterile devices, implantable devices, IVD reagents, custom-made dentures and standalone software devices must meet both the revised GMP and the existing category-specific annexes. The NMPA will issue updated inspection guidelines for those categories separately.