NMPA issued the “Good Manufacturing Practice for Medical Devices: Inspection Guidelines for In Vitro Diagnostic Reagents (Draft)” on September 29, 2026. The document combines the China new GMP with its IVD-specific Appendix, and converts both into a checklist of 212 inspection items:
- 42 critical items (***)
- 93 major items (**)
- 77 general items (*)
Inspection types and result determination follow the existing general GMP inspection guideline. Every item cites its source clause in the GMP or the IVD Appendix, so inspectors and companies can trace requirements back to the regulation.
11 Class III devices and 66 IVDs are to be exempted from clinical trial. Click HERE for more info
Click HERE for “Clinical Evaluation Guideline for Cancer Screening IVDs”
Click HERE for 268 items of IVD classifications
Key Points from the Draft Guideline
1. General provisions and quality assurance. Companies must build a quality management system that fits their products and runs effectively. It must cover contracted development, contract manufacturing, outsourced processing and contracted testing. Risk management must run through the whole system. Management must set quality objectives, provide enough people, premises and equipment, and take responsibility for product safety. The critical items are:
- a documented quality assurance system
- batch release only after review and approval
- a change control procedure that assesses risk before implementation
Continuous improvement relies on data monitoring, adverse event monitoring, CAPA, internal audit and management review.
2. Organization and personnel. Key positions include:
- the legal representative
- the person in charge
- the management representative
- the heads of production and quality
- the release reviewer
The main rules are:
- Production and quality heads may not hold both roles.
- The quality department must act independently and has veto power over product quality.
- Management must let the management representative, quality head and release reviewer work free of internal interference.
- The management representative, quality head and release reviewer must be full-time staff.
- Qualification requirements are set for these roles: a bachelor’s degree or intermediate title for Class II/III companies, and at least three years of relevant experience.
- Technical and quality staff need relevant backgrounds such as medicine, laboratory science, biology, immunology or pharmacy.
- All staff need role-specific training, and cleanroom and biosafety training for IVD work.
- Health management is required. Staff in direct contact with materials or products get an annual medical examination, and people with infectious diseases are barred from such work.
3. Premises and facilities. This chapter has the most IVD-specific content.
- Layout must prevent contamination, cross-contamination and mix-ups. Personnel and material flows must be sensible, and animal rooms must be separate.
- Cleanroom grades depend on the product. ELISA, immunofluorescence, chemiluminescence, PCR, colloidal gold and dry-chemistry reagents, along with cell culture media, calibrators, controls, enzymes, antigens and antibodies, require at least Class 100,000 for formulation, dispensing, coating and packaging. Handling of positive or negative sera, plasmids or blood products requires at least Class 10,000 with relative negative pressure. Aseptic dispensing needs local Class 100.
- Typical cleanroom conditions are 18–28 °C and 45–65% relative humidity, with pressure differentials above 10 Pa between clean and non-clean areas and above 5 Pa between grades.
- Air purification systems must be qualified, run continuously and be re-verified, including after any shutdown.
- Process water is a critical item. Quality must meet pharmacopoeia or national standards, and storage tanks and pipelines need regular cleaning and disinfection.
- PCR reagent production is critical. Production and testing must be in separate buildings or spaces with no direct air connection, and tools must not be shared, to prevent aerosol contamination.
- Infectious, highly pathogenic or biologically active materials need controlled handling, biosafety cabinets and filtered exhaust.
4. Equipment. Equipment must match product and scale, and have files, maintenance procedures, identification and status labels. Calibration ranges must cover actual use. Equipment that has been modified or heavily repaired must be requalified.
5. Documents and data. The system needs a quality manual, procedures, technical documents and records, with controlled revision and distribution. Records must be true, accurate, complete, timely and traceable, with no unexplained alterations. They must be kept for at least the product’s lifetime and no less than two years after release. Electronic records, a critical item, require access control, audit trails of changes and deletions, backups and compliant e-signatures.
6. Design and development. Companies must define development stages, plans, inputs, outputs, transfer to production, review, verification, validation and change control. Transfer to production and design changes are critical items. IVD-specific development records must cover:
- equipment and reagents used
- sources and quantities of key materials
- sample quantities, storage, retention and disposal across process, analytical performance, stability, clinical and reference-range studies
Outsourced development requires capability assessment and a written agreement, and the commissioning company stays responsible.
7. Purchasing and raw materials. Suppliers must be classified, audited, re-evaluated and covered by quality agreements. Critical items include:
- stopping purchases from suppliers with major defects
- incoming inspection, including traceability of standards, calibrators, controls and blood sources, with records of origin, assigned values, inactivation status and quantities
- re-testing of expired or changed-condition materials, with expired materials treated as nonconforming
8. Verification and validation. The scope of validation should follow risk assessment. Critical items are:
- qualification of facilities and major equipment
- validation of key processes and confirmation of special processes
- re-validation when key materials, environment, processes, equipment or test methods change
Cleaning methods and quality-relevant software must also be validated.
9. Production management. Key rules:
- Batch numbering and records must support full traceability. Where kit components have different batch numbers, the kit expiry follows the earliest-expiring component.
- Cleanroom hygiene, gowning and disinfection must be controlled, and disinfectants rotated.
- Material balance, labelling, line clearance, deviation handling and nonconforming product control are required.
- Unique Device Identification (UDI) coding and data upload are required.
- Shared lines need risk-based segregation.
- Re-validation is required after production stops, for a stoppage of more than one year in particular.
- Inactivated serum or plasma must be clearly distinguished, and waste must be made harmless.
10. Quality control and release. Inspection procedures must cover all performance specifications. Calibrators and reference materials need value assignment and traceability. Strains and cell lines need a seed-lot or cell-bank system. The critical items are:
- inspection per procedure
- batch inspection records
- written release procedures that check complete production and QC records, handling of special cases and correct labelling
- a split in contract manufacturing: the manufacturer handles production release and the registrant handles market release
- routine testing items generally may not be outsourced
11. Contract manufacturing and outsourced processing. The commissioning party’s system must cover the full product lifecycle. The two parties need a quality agreement, and the commissioning party cannot transfer its legal responsibilities to the contractor. The commissioning party must assess the contractor on site before and during contracting. The contractor must run trial production covering the full transferred process. Market release cannot be outsourced. Outsourced processors are managed as suppliers.
12. Sales, after-sales, analysis and improvement. Companies must keep sales records, validate cold-chain transport, and maintain after-sales service. Complaint handling, adverse event monitoring, data analysis, CAPA, recall, advisory notices, internal audit and management review must all operate and be documented.
Takeaways from the Draft Guideline
- Failure on critical items is most dangerous. These cover independence of the quality function, process water, PCR separation, traceability, electronic data integrity, process validation, change control and release.
- IVD companies face tighter controls than general device makers. The extra requirements cover cleanroom grades by reagent type, biosafety, calibrator and reference-material traceability, and cell-bank management.
- Contract manufacturing responsibility is not transferable. The registrant retains quality accountability and market release.
- Records are the main evidence of compliance. Inspectors will check traceability from raw materials through release and sales.