The NMPA issued the “Guideline for Inspection under the Medical Device Good Manufacturing Practices” on September 15, 2026, which will take effect on November 1, 2026. The final guideline follows the June 9, 2026 draft and marks a further step toward risk-based, lifecycle-oriented regulation of medical device manufacturing in China.
The document converts the China new GMP into 200 inspection items: 39 critical items (***), 88 major items (**), and 73 general items (*). Manufacturers should conduct gap analyses against the final requirements, update their quality management systems (QMS), and prepare for both manufacturing license inspections and post-market surveillance inspections.
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Scope of Application
The guideline applies to:
– Manufacturing license inspections, including changes and renewals; and
– All post-market surveillance inspections for registrants, filers, and contract manufacturers.
Inspection Items and Classification
Based on the importance of each clause in the quality management system and the risk posed by non-compliance, inspection items are divided into three levels:
– Critical items (***) – 39 items: Major impact on the quality management system; non-compliance may cause product safety risks.
– Major items (**) – 88 items: Significant impact; cumulative non-conformities may lead to quality safety risks.
– General items (*) – 73 items: Some impact; non-compliance may still affect product quality and safety.
Inspection Types and Decisions
1. Manufacturing License Inspections
Manufacturing license inspections have three possible outcomes: Pass, Fail, and Rectify and Re-inspect.
– Pass: No critical or major non-conformities, and fewer than 5 general non-conformities. The company should complete rectification and explain it in the annual self-inspection report.
– Fail: Fraud or deception; 3 or more critical non-conformities; 10 or more critical plus major non-conformities; or 20 or more total non-conformities.
– Rectify and Re-inspect: Any other case. If rectification is completed within the deadline and confirmed, the final conclusion is Pass. If not, the final conclusion is Fail.
2. Post-Market Surveillance Inspections
Post-market surveillance inspections are divided into full-scope and partial-scope inspections. Full-scope inspections have four outcomes:
– No non-conformities found: No non-conformities were identified.
– Self-rectification: No critical or major non-conformities, and fewer than 5 general non-conformities.
– Suspend production for rectification: Fraud or deception; 3 or more critical non-conformities; 10 or more critical plus major non-conformities; or 20 or more total non-conformities. The company must suspend production, complete all rectification, and pass a follow-up inspection before resuming production.
– Rectify within deadline: Any other case. If rectification is not submitted or not completed within the deadline, the final conclusion becomes Suspend production for rectification.
For partial-scope inspections, specific chapters must be covered. For self-manufacturing registrants or filers, the minimum coverage includes quality assurance, procurement and raw material management, production management, quality control and product release, and analysis and improvement. For contract manufacturing registrants or filers, the minimum coverage includes quality assurance, organization and personnel, quality control and product release, contract manufacturing and outsourcing, and analysis and improvement. For contract manufacturers, the minimum coverage includes quality assurance, procurement and raw material management, production management, quality control and product release, and analysis and improvement. Decision rules follow those for full-scope inspections.
Enhanced Risk Considerations
The final guideline emphasizes comprehensive risk assessment:
– Systemic risks: If multiple interrelated non-conformities may cause systemic risks in the quality management system, they shall be deemed as a critical non-conformity in the “Quality Assurance” chapter.
– Repeat non-conformities: If the same entity repeats non-conformities found in previous inspections, indicating ineffective correction or lack of preventive action, the risk level may be elevated by one level.
– Fraud or deception: This directly leads to Fail in manufacturing license inspections or Suspend production for rectification in post-market surveillance. Evidence should be collected and recorded, and suspected legal violations should be referred to enforcement authorities.
– Suspension consequences: When production is suspended for rectification, the registrant or filer must fully assess product safety risks and recall products if necessary.
Key Differences Between the Draft and Final Guideline
Compared with the June 2026 draft, the final guideline makes several key changes:
- Item counts and risk levels: Total remains 200 and critical remains 39, but major items rose from 86 to 88 and general fell from 75 to 73. Risk levels were rebalanced—e.g., product labels/instructions dropped from critical to major, quality control procedure rose to critical, clause 14.1.1 dropped to major, facility siting/design/layout and design input 7.4.1 rose to major, and legal representative duties were reorganized.
- Post-market outcomes: The draft had three outcomes (self-rectification, suspend production, rectify within deadline). The final restores four by adding “no non-conformities found.” License inspections remain three: pass, fail, rectify and re-inspect.
- Thresholds: Total non-conformities now trigger “fail” or “suspend production” at 20 or more; the draft used more than 20. Critical (3+) and critical plus major (10+) thresholds are unchanged.
- Fraud and systemic risk: Fraud directly leads to “fail” or “suspend production,” with evidence collection and possible enforcement referral. Systemic risk wording changed from “may be deemed” to “shall be deemed” a critical Quality Assurance issue.
- Repeat issues and recalls: Repeated non-conformities may raise the risk level by one. If production is suspended, the registrant or filer must assess safety risks and recall products if necessary.
These changes make the final guideline stricter on total non-conformities and clearer on fraud and systemic risk.
Key “Critical” Inspection Items
The final guideline identifies 39 critical items. These represent the highest-priority areas for compliance and inspection focus. They include, among others:
– Quality system covering commissioned R&D, production, outsourcing, and commissioned testing.
– Primary responsibility for quality safety and systematic implementation of quality objectives.
– Sufficient personnel, facilities, and equipment for quality objectives.
– Complete quality assurance system and documented QMS.
– Change control procedures evaluating impact on safety, efficacy, and quality.
– Production and quality department heads must not be mutually assigned.
– Establishment of a quality department suitable for the products.
– Independent QA/QC functions and product veto power.
– Independent performance of the management representative, quality head, and release approver.
– Legal representative/principal organizing production according to regulations and registered or filed product technical requirements.
– Appointment of a management representative.
– Facilities such as HVAC, process water, process gas, and anti-static systems.
– Production equipment, inspection instruments, and tooling matching product and scale.
– Record control ensuring traceability, authenticity, accuracy, completeness, and timeliness.
– Electronic records: user access, change and deletion logs, backup, and electronic signatures.
– Design output including procurement, production, and inspection information, validated and approved.
– Design transfer, with critical and special processes verified and validated.
– Design changes identified, evaluated, validated or verified, and approved before implementation.
– Procurement control procedures for materials and services.
– Suspension of purchasing when a supplier has major deficiencies, with product risk analysis.
– Incoming inspection before warehouse acceptance.
– Re-testing of materials exceeding storage period; expired materials treated as nonconforming.
– Confirmation of facilities and major equipment; use of validated processes.
– Special processes validated and critical processes verified.
– Changes to critical materials, environment, processes, equipment, or test methods validated.
– Production process control covering operators, equipment, materials, environment, and monitoring.
– Traceable production records for each batch or unit.
– Quality control procedures.
– Incoming, in-process, and finished product inspection procedures.
– Test methods appropriate for product performance indicators.
– Inspection performed according to procedures.
– Traceable inspection records for each batch or unit.
– Product release procedures covering process steps, records, QC results, special cases, and labeling/UDI.
– Contract manufacturing: production release by the contract manufacturer and market release by the registrant.
– Registrant’s QMS covering the full lifecycle; contract manufacturer’s QMS covering contracted activities.
– Quality agreement defining responsibilities; statutory duties cannot be transferred.
– Contract manufacturer conducting trial production and validation of transferred processes.
– Registrant establishing market release procedures.
– Contract manufacturer establishing production release procedures.