China NMPA: 2026 GMP Inspection Criteria

China's National Medical Products Administration (NMPA) has issued inspection guiding principles for its revised medical device Good Manufacturing Practice (GMP), effective 1 November 2026. The notice, Guo Yao Jian Xie Guan [2026] No. 14, is dated 14 September 2026; an official Shanghai regulator republication dated 16 September reproduces the notice and links to the NMPA original.

The final inspection guiding principles apply to production-licence inspections, including changes and renewals, and post-market supervision of medical device registrants, record-filing holders and contract manufacturers. They specify how inspectors classify findings and determine inspection outcomes under the revised GMP. They are an issued regulatory inspection framework, not a consultation draft or a new medical device product-registration pathway.

Which inspections switch on 1 November

The notice sets the following transition arrangements:

• Before 1 November: production-licence inspections use the current GMP, while regulators also assess readiness against the revised GMP and recommend corrections.
• Pending licence applications: applications accepted before 1 November switch to inspection under the revised GMP if they have not had an on-site inspection, or if an inspection has occurred but the licensing decision remains outstanding because the enterprise has not completed rectification. The second condition does not encompass every undecided application.
• Class I production filings: regulators must inspect the submitted materials and GMP implementation within three months after filing. Filings made before 1 November that have not yet been inspected are inspected under the revised GMP from that date.
• Post-market supervision: provincial regulators must arrange phased coverage based on product and enterprise risk to achieve continuing compliance with the revised GMP.

The earlier generic on-site inspection guiding principles, issued in the year 2015 under notice [2015] No. 218, are repealed on 1 November. For sterile devices, implantable devices, IVD reagents, custom-made dentures and standalone software, production quality management must meet both the revised GMP and the applicable existing GMP annexes. Corresponding specialised inspection guidance will be revised separately; the notice gives no publication date for it.

A 200-item checklist with three risk grades

Section II of the guiding principles classifies 200 inspection items: 39 critical, 88 major and 73 general. The grading reflects each item's effect on the quality management system and the risk caused by nonconformity. General findings can also create product quality and safety risk; they are not merely administrative defects.

The principal result thresholds in Section III are:

Each condition in the third row is an independent trigger. A failed licensing inspection is an inspection outcome; the guiding principles do not equate it with automatic revocation of an existing licence. Separate violations are handled under the applicable laws and regulations.

Where self-correction applies, the enterprise must correct the findings and explain them in its annual self-inspection report. For licensing cases requiring re-inspection, timely correction confirmed by a follow-up inspection leads to a pass. Failure to submit rectification materials within the specified time, or inadequate correction on follow-up, leads to a fail.

For post-market cases requiring correction by a deadline, the regulator must assess product risk where critical or major findings exist and may issue a risk-warning letter if necessary. Missing the submission deadline or inadequate correction on follow-up escalates the outcome to suspension. Production may resume only after all findings are corrected and the regulator's follow-up inspection is passed. A suspended registrant or record-filing holder must assess product quality and safety risk comprehensively and recall affected products if necessary.

Counts alone do not determine every risk judgment

Section IV requires a combined assessment of finding severity and product risk. Interrelated findings that may cause a systemic quality-management risk are treated as a critical finding in the quality-assurance chapter. A nonconformity repeated in the previous two inspections may be raised by one risk grade, depending on the circumstances.

Partial-scope post-market inspections use the same result rules as full-scope inspections. Their minimum chapter coverage varies by operating model: self-producing registrants, record-filing holders and contract manufacturers share one minimum set, while registrants and record-filing holders outsourcing production have another. The latter expressly includes organisation and personnel, and contracted production and outsourced processing. A shorter inspection does not create more lenient thresholds.

Preparation for the revised framework

Pure Global analysis: Quality teams should map the 200-item checklist to their operating model, gather evidence for corrective actions, and review recurring or interconnected findings before relying on a numerical pre-inspection assessment. Being below a suspension or failure threshold does not remove the duty to correct findings, prevent risk escalation or address separate legal violations.

For an application already in progress, record its acceptance date, whether an on-site inspection has occurred, and whether outstanding rectification is holding up the decision. These facts determine whether the notice's pending-application transition applies. Manufacturers in the five specialised categories should maintain their applicable annex controls while preparing for the revised general GMP; they should not wait for the forthcoming specialised inspection guidance to begin that work.

For background on the underlying GMP, see China's Revised Medical Device GMP Takes Effect on 1 November 2026, alongside the China market overview and NMPA glossary.