The NMPA released the Draft Guideline for Inspection under the Medical Device Good Manufacturing Practices on June 9, 2026. Feedbacks need to be submitted by June 24, 2026.
This draft represents a major step toward risk‑based, lifecycle‑oriented regulation of medical device manufacturing in China. It lists 39 critical check items that must be strictly controlled to maintain compliance. Manufacturers are advised to conduct gap analyses against these requirements before the final guideline takes effect.
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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.
The document translates the Medical Device GMP into 200 inspection items grouped by risks:
– 39 Critical items (***) – Major impact on quality system; may cause product safety risks.
– 86 Major items (**) – Significant impact; cumulative non‑conformities can lead to risks.
– 75 General items (*) – Lower impact but still affect system performance.
Inspection Decisions
1. Manufacturing License Inspections
Three outcomes: Pass, Fail, or Rectify and Re‑inspect.
– Pass – No critical/major non‑conformities, and general non‑conformities <5.
– Fail – Fraud/deception; critical >2; critical+major ≥10; total non‑conformities >20.
– Rectify – Any other case. If not corrected within deadline, the final conclusion is Fail.
2. Post‑Market Surveillance Inspections
Two types: full‑scope and partial‑scope inspections. Outcomes: Self‑rectification, Suspend production for rectification, or Rectify within deadline.
– Self‑rectification – No critical/major non‑conformities, general <5.
– Suspend production.0 – Fraud/deception; critical >2; critical+major ≥10; total non‑conformities >20.
– Rectify within deadline – All other cases. Failure to rectify leads to Suspend production.
For partial‑scope inspections, specific chapters must be covered (e.g., quality assurance, production management, quality control), and the same decision rules apply.
Enhanced Risk Considerations
– Systemic risks – Interrelated non‑conformities may be treated as a critical item in the “Quality Assurance” chapter.
– Repeat deviations – May elevate the risk level of an item.
– Fraud/deception – Directly leads to “Fail” (license inspection) or “Suspend production” (surveillance), with possible legal referral.
All industry stakeholders are encouraged to review the full draft and submit comments to NMPA before June 24, 2026.
List of Critical Inspection Items
The following 39 items are classified as critical (***) under the draft guideline. They represent the highest priority for compliance and inspection focus.
- Quality system covers commissioned R&D, production, and testing.
- Primary responsibility for quality safety; quality objectives systematically implemented.
- Sufficient resources (personnel, facilities, equipment) for quality objectives.
- Complete quality assurance system and documentation.
- Change control procedure evaluating impact on safety, efficacy, quality.
- Production and quality department heads shall not be mutually assigned.
- Establish a quality department suitable for the products.
- Quality department independently performs QA/QC and has product veto power.
- Legal representative/principal ensures production per regulations.
- Ensure management representative, quality head, release approver act independently.
- Facilities (HVAC, water, gas, antistatic) as required.
- Production equipment and inspection instruments matching product and scale.
- Record control: traceability, authenticity, accuracy, completeness, timeliness.
- Electronic records: user access, backup, change logs, e‑signatures.
- Design output includes procurement, production, inspection info; validated and approved.
- Design transfer; verify critical and special processes.
- Design changes: validate/verify as needed; approve before implementation.
- Procurement control procedure for materials/services.
- Suspend purchasing if supplier major deficiency; analyze product risk.
- Incoming inspection before warehouse acceptance.
- Expired materials: re‑test or treat as nonconforming.
- Facilities and equipment validated; use validated processes.
- Special processes validated; key processes verified.
- Changes to critical materials, environment, process, equipment, method require validation.
- Process control covering operators, materials, environment, monitoring.
- Each batch/unit has traceable production records.
- Labeling and instructions comply with regulations; effectively controlled.
- In‑process and final inspection procedures based on risk and specifications.
- Test methods appropriate for product performance indicators.
- Perform inspections per procedures.
- Each batch/unit has traceable inspection records.
- Product release procedure: process steps, records, QC, special cases resolved, labeling/UDI correct.
- Contract manufacturing: production release by contract manufacturer; market release by registrant.
- Registrant’s quality system covers lifecycle; contract manufacturer’s system covers contract activities.
- Quality agreement defines responsibilities; registrant cannot transfer statutory duties.
- Contract manufacturer performs trial production and validation of transferred processes.
- Registrant establishes market release procedure; reviews records before signing off.
- Contract manufacturer establishes production release procedure.
- Monitoring, analysis, improvement to ensure safety and system effectiveness.