China NMPA Issues New Medical Device GMP Inspection Guidelines

On September 15, 2026, China’s National Medical Products Administration (NMPA) issued the Guidelines for Inspection of Good Manufacturing Practice in Medical Devices (2026 No. 14).

Effective November 1, 2026, the new guidelines replace the 2015 medical device GMP inspection guidance. They introduce a revised checklist of 200 inspection items, classified by risk as critical, major, or general:

• 39 critical items
• 88 major items
• 73 general items

The guidelines establish a consistent framework for assessing manufacturing compliance and help manufacturers prepare for regulatory inspections. They complement the revised Good Manufacturing Practice for Medical Devices (2025 No. 107), issued on November 4, 2025. Both take effect on November 1, 2026.

Key Changes to China’s Medical Device GMP Inspection Framework

The updated checklist provides a practical basis for assessing existing quality management systems (QMS) against the revised requirements. Manufacturers can use it to identify compliance gaps, prioritize corrective actions, and prepare for inspections before the deadline.

The 200 items cover 14 chapters, spanning quality assurance, personnel, facilities, equipment, documentation and data management, design and development, supplier controls, verification and validation, production, product release, contract manufacturing, and post-market quality activities. Manufacturers should therefore assess their entire QMS, not just production procedures.

Inspection Outcomes and Compliance Thresholds

The guidelines distinguish between production license inspections and post-market supervision inspections, with outcomes determined by the severity and number of nonconforming inspection items.

Production license inspections cover applications for new licenses, changes, and renewals. Outcomes include “passed,” “not passed,” and “reinspection following rectification.”

Subject to the rule on false or deceptive conduct, a licensing inspection is classified as passed where there are no nonconforming critical or major items and fewer than five nonconforming general items. Any identified nonconformities must still be rectified by the enterprise and explained in its annual self-inspection report. An inspection is classified as not passed if any of the following applies:

• Fraudulent or deceptive conduct
• Three or more critical findings
• Ten or more combined critical and major findings
• Twenty or more findings overall

Cases falling between the pass and fail thresholds require corrective action and follow-up verification. A final pass requires rectification within the prescribed period and confirmation of compliance through a follow-up inspection. Failure to submit rectification materials within the prescribed period, or inadequate rectification identified during follow-up, results in a final conclusion of not passed. Production may resume only after all nonconforming items have been rectified and the drug regulatory authority has confirmed compliance through a follow-up inspection. The guidelines also provide for inspections covering selected chapters; their results are assessed using the full-scope inspection rules.

Post-market inspections may result in no deficiencies identified, self-correction, time-limited rectification, or suspension of production for corrective action. Under the full-scope inspection framework, the thresholds for production suspension include the same numerical criteria listed above.

Repeated findings from the previous two inspections may be assigned a higher risk classification. Multiple interconnected deficiencies indicating systemic weaknesses may also be treated as a critical deficiency in quality assurance.

Transitional Arrangements Before November 1, 2026

Manufacturers should not wait until the effective date to prepare. During the transition period, regulatory authorities will continue conducting production license inspections under the existing GMP requirements while using the new guidance to assess readiness and recommend corrective actions.

For Class I medical device manufacturing filings, authorities must conduct an on-site inspection of the submitted materials and GMP implementation within three months after filing. Where a manufacturing filing was made before November 1, 2026, but the on-site inspection has not yet occurred, inspections from that date must follow the revised GMP.

For Class II and Class III medical devices, inspections relating to manufacturing license applications—including applications for license changes and renewals—accepted before November 1, 2026, must follow the revised GMP from that date in either of the following circumstances:

• The on-site inspection has not yet taken place; or
• The on-site inspection has taken place, but no administrative licensing decision has been made because the enterprise has not completed rectification.

Provincial authorities must also plan post-market supervision inspections according to product and enterprise risks and achieve full inspection coverage in stages against the revised GMP.

Additional Requirements for Specific Medical Device Categories

In addition to the core GMP requirements, manufacturers of certain medical device categories must comply with the relevant appendix requirements.

These categories include:

• Sterile medical devices
• Implantable medical devices
• In vitro diagnostic (IVD) medical devices
• Custom-made dentures
• Standalone-software medical devices

Supplementary inspection guidance for these categories is being developed separately. Manufacturers should monitor NMPA announcements for the latest documents and distinguish between draft guidance released for public consultation and finalized requirements.

In the meantime, affected companies should evaluate their compliance with the revised core GMP requirements and identify any additional controls that may be necessary for their products and manufacturing processes.

How to Prepare Ahead of the November 1 Deadline

Foreign medical device manufacturers supplying the Chinese market should begin reviewing their existing compliance arrangements well ahead of the implementation date. A structured assessment against the revised GMP requirements and inspection checklist can help identify gaps early, clarify the scope of necessary changes, and support a more efficient transition.

Key preparation steps include:

Assess GMP Compliance and Inspection Readiness

Compare existing QMS processes, manufacturing operations, and supporting documentation against the revised GMP requirements and inspection checklist. Conduct internal GMP self-inspections, assess the severity of findings, and prioritize corrective and preventive actions (CAPA).

Ensure that deficiencies are properly investigated, documented, and verified after remediation. Serious or unresolved findings can lead to failed licensing assessments or production suspension.

Review and Update SOPs and Quality Management Systems

Evaluate standard operating procedures (SOPs), quality documentation, and QMS processes for necessary updates. Pay particular attention to:

• Document control and electronic data integrity
• Supplier qualification and raw material controls
• Verification, validation and production records
• Product release and traceability
• Complaints, adverse event monitoring, and recalls

Companies using contract manufacturers should also review quality agreements, supplier oversight, production transfer, and change-control procedures. Responsibilities for production release and market release should be clearly defined; the legal manufacturer retains responsibility for market release.

Assess Product Risks and Corrective Actions

Evaluate whether identified deficiencies could affect the safety, performance, or quality of products already on the market. Depending on the findings and associated risks, additional controls or product recalls may be necessary.

Corrective actions should address root causes, not just individual findings. Allow sufficient time to implement, document, and verify remediation before regulatory inspections.

Monitor Supplementary Inspection Guidance

Track the release of dedicated appendix inspection guidance for sterile, implantable, IVD, custom-made denture, and standalone software medical devices, as applicable, and assess any additional compliance implications for affected products.

Final Thoughts: Prepare Now for China’s Revised Medical Device GMP Requirements

As the effective date of November 1, 2026, approaches for both the revised GMP rules and the new inspection guidelines, medical device manufacturers should act swiftly to evaluate their current quality management systems. Identifying compliance gaps and preparing for audits under these updated criteria is critical for maintaining market access.

Successfully navigating these complex regulatory shifts requires careful preparation and expert insight. Cisema can help medical device manufacturers prepare for China’s revised GMP requirements through expert English translations of the new GMP and inspection guidelines, detailed change-comparison tables, and impact analyses for products and registrations in China.

To ensure a seamless transition and keep your compliance strategy on track, support is just a conversation away. Contact Cisema today to discuss how we can assist with your assessment and implementation planning.

Further Information

• Learn more about Cisema's services for China medical device GMP compliance.
• Explore Cisema’s services for medical device registration in China.
• Read more of Cisema’s coverage on China’s updated GMP requirements for medical devices:
  
  • China NMPA Issues New GMP (Good Manufacturing Practice) for Medical Devices
  • China Medical Device GMP Readiness: A Checklist for Overseas Manufacturers
  • China Medical Device GMP vs ISO 13485: Key Differences Explained

References

• Guidelines for Inspection of Good Manufacturing Practice in Medical Devices (2026 No. 14)