NMPA Releases the Guidance for Inspection of Medical Device Production Quality Management, Effective November 1, 2026

On September 15, 2026, the National Medical Products Administration issued the “Notice of the NMPA on Issuing the Guidance for Inspection of Medical Device Production Quality Management,” document No. Guo Yao Jian Xie Guan [2026] No. 14. The newly revised Medical Device Production Quality Management Specification (GMP) will take effect on November 1, 2026. The Guidance for Inspection of Medical Device Production Quality Management will take effect on the same date, and the former  “Guidance for On-site Inspection of Medical Device Production Quality Management Specification” (Shi Yao Jian Xie Jian [2015] No. 218) will be repealed simultaneously.

The notice clarifies that from November 1, 2026, drug regulatory authorities shall strictly follow the newly revised GMP to conduct medical device production license verification and post-market supervision inspections, and shall make determinations and take actions according to the Inspection Guidance. Before November 1, 2026, authorities shall conduct production license verification under the current GMP, and at the same time refer to the Inspection Guidance to assess enterprises’ implementation of the newly revised GMP and propose rectification suggestions. For applications already accepted but not yet inspected on site, or already inspected on site but no administrative licensing decision has been made because the enterprise has not completed rectification, inspections shall be conducted under the newly revised GMP from November 1, 2026. After Class I medical device production filing, the drug regulatory authority shall conduct an on-site inspection of the filed materials and GMP implementation within three months. Provincial drug regulatory authorities shall, in accordance with the new GMP, formulate post-market supervision inspection plans based on product and enterprise risks, and complete full-coverage inspections in phases. From November 1, 2026, the production quality management of sterile, implantable, in vitro diagnostic reagent, custom-made denture, and standalone software medical devices shall simultaneously comply with the newly revised GMP and the corresponding current GMP annexes.

The Inspection Guidance applies to medical device production license verification, including changes and renewals, and various post-market supervision inspections. There are 200 inspection items in total, including 39 critical items, 88 major items, and 73 general items. Critical items are marked with “***” major items with “**” and general items with “*”.

Production license verification conclusions are divided into “passed verification,” “failed verification,” and “re-inspection after rectification.” If no critical or major item nonconformity is found and the number of general item nonconformities is fewer than 5, the conclusion is “passed verification.” If there are false or deceptive acts, 3 or more critical item nonconformities, 10 or more total critical and major item nonconformities, or 20 or more total nonconformities, the conclusion is “failed verification.” Other circumstances are “re-inspection after rectification.” If follow-up inspection confirms compliance after rectification, the final conclusion is “passed verification”; if rectification materials are not submitted or rectification is incomplete, the final conclusion is “failed verification.”

Post-market supervision inspections are divided into full-item inspections and non-full-item inspections, with conclusions of “no nonconformities found,” “self-rectification,” “suspension of production for rectification,” and “rectification within a prescribed time limit.” If no nonconformities are found in a full-item inspection, the conclusion is “no nonconformities found.” If no critical or major item nonconformity is found but general item nonconformities are fewer than 5, the conclusion is “self-rectification.” If there are false or deceptive acts, 3 or more critical item nonconformities, 10 or more total critical and major item nonconformities, or 20 or more total nonconformities, the conclusion is “suspension of production for rectification.” Other circumstances are “rectification within a prescribed time limit.” If time-limited rectification involves critical or major nonconformities, the authority shall fully assess product quality risks and, when necessary, send a risk reminder letter; if rectification materials are not submitted or rectification is incomplete, the final conclusion shall be “suspension of production for rectification.” Non-full-item inspections shall cover at least key chapters such as quality assurance, procurement and raw material management, production management, quality control and product release, and analysis and improvement, and results shall be determined in accordance with full-item inspections.

Other requirements include: drug regulatory authorities shall comprehensively assess the severity of nonconformities and product risks; if multiple interrelated nonconformities may lead to systemic risks in the quality management system, they shall be deemed a critical nonconformity in the “Quality Assurance” chapter; if nonconformities recur in the previous two inspections, the risk level may be upgraded by one level. For “suspension of production for rectification,” the registrant or filing person shall comprehensively assess product quality and safety risks and, when necessary, recall relevant products. If laws, regulations, or rules are violated, actions shall be taken in accordance with the law.

The annex “Inspection Items of the GMP” contains 200 items and covers 14 chapters: General Provisions, Quality Assurance, Organization and Personnel, Premises and Facilities, Equipment, Document and Data Management, Design and Development, Procurement and Raw Material Management, Verification and Validation, Production Management, Quality Control and Product Release, Contract Manufacturing and Outsourcing, Sales and After-sales Service, and Analysis and Improvement. The numbering rule is X1.X2.X3, where X1 is the chapter sequence number, X2 is the clause sequence number within the same chapter, and X3 is the detailed inspection item sequence number within the same clause. Specific clauses shall be subject to the official annex.

For enterprises, the new rules directly link inspection conclusions to risk levels, the number of nonconformities, systemic risk, and closed-loop rectification. Companies should benchmark against the new GMP and the Inspection Guidance as soon as possible, conduct gap analyses, update quality management system documents, strengthen training, validation, audits, and rectification closure, and complete preparations before November 1, 2026.