NMPA Solicits Public Comments on Inspection Guidelines for Sterile and Implantable Medical Devices

Release date: September 24, 2026

Issuing authority: General Office of the National Medical Products Administration

Comment deadline: October 8, 2026

Feedback email: mdgmp@cfdi.org.cn

Attachment 1, the Inspection Guidelines for Sterile Medical Devices under the Medical Device GMP (Draft for Comments), states that based on the importance of each provision of the Medical Device GMP and the Appendix for Sterile Medical Devices in the quality management system, as well as the degree of quality and safety risk caused by non-compliance, the appendix content is integrated with the GMP and transformed into inspection items for sterile medical devices. The items are divided into three levels: critical items (), major items (), and general items (). There are 216 inspection items in total, including 41 critical items, 95 major items, and 80 general items. Inspection types and result determination follow the Inspection Guidelines for the Medical Device GMP. The attached inspection items are organized into 14 chapters: Chapter 1 General Provisions, emphasizing that enterprises should establish and maintain a quality management system suitable for the medical devices they produce, covering contracted research and development, contracted manufacturing, outsourced processing, and contracted testing, and should apply risk management throughout the operation of the quality management system; Chapter 2 Quality Assurance, covering quality and safety responsibility, quality objectives, resource allocation, the quality assurance system, change control, continuous improvement, quality risk management, and lifecycle quality risk review; Chapter 3 Organization and Personnel, covering organizational structure, separation of production and quality management heads, independent quality assurance and quality control functions with veto power over product quality, key positions and full-time requirements, management representative, quality management department head, production management department head, release reviewer, training, cleanroom hygiene and microbiology training, and health management; Chapter 4 Premises and Facilities, covering site selection, design, layout, construction, renovation and maintenance, cleanroom layout and personnel/material flows, temperature and humidity, dust and pest prevention, static pressure differential, process water, process gas, testing premises, and hardware and software environment for information systems; Chapter 5 Equipment, covering production equipment, testing instruments and equipment, fixtures, equipment files, operation and maintenance procedures, numbering and identification, calibration or verification, measuring instruments, and re-qualification after modification or major repair; Chapter 6 Documentation and Data Management, covering quality policy and objectives, quality manual, procedure documents, technical documents, document control, record control, authenticity, accuracy, completeness, timeliness and clarity of records, retention periods, electronic records, and electronic signatures; Chapter 7 Design and Development, covering design and development control procedures, risk management, planning, inputs, outputs, transfer, review, verification, validation, changes, design and development documentation, and contracted design and development; Chapter 8 Purchasing and Raw Material Management, covering purchasing control procedures, supplier classification, supplier audits, on-site audits, periodic evaluation, quality agreements, key supplier quality files, purchasing information, purchasing records, incoming inspection, primary packaging materials, warehousing, first-in-first-out, re-inspection after storage expiry, and supplier change notification; Chapter 9 Verification and Validation, covering risk-based determination of verification or validation scope, qualification of premises, facilities and equipment, process validation, special process validation, critical process verification, sterilization or aseptic processing validation, cleaning validation, change validation, revalidation, retrospective validation, validation protocols and reports, and computer software validation; Chapter 10 Production Management, covering production process control procedures, cleanroom hygiene management, personnel cleaning requirements, clothing requirements, control of raw materials and intermediate products, bioburden and particulate contamination control, workstation utensils, environmental monitoring, batch numbering, production records, sterilization process records, traceability, material balance, product identification, instructions and labels, product protection, line clearance, deviation handling, nonconforming product control, rework, product traceability, UDI, shared workshops and production lines, continuous production, and resumption after shutdown; Chapter 11 Quality Control and Product Release, covering quality control procedures, inspectors, incoming, in-process and finished product inspection procedures, bioburden and particulate testing, test methods, reference standards, strains, culture media and other auxiliary materials, inspection sample management, inspection records, inspection equipment management, inspection environment, nonconformity investigation, product release conditions, certificates of conformity, contract manufacturing release, retained samples, and contracted testing; Chapter 12 Contract Manufacturing and Outsourced Processing, covering the contract giver’s quality management system covering the full lifecycle, communication mechanism, quality agreement, on-site assessment of the contract manufacturer, key personnel of the contract manufacturer, production transfer, trial production and verification/validation, change management, market release and production release, outsourced processing control procedures, evaluation of outsourced processors, and outsourced processing quality agreements; Chapter 13 Sales and After-Sales Service, covering product sales and after-sales service, sales records, transport conditions and tools, transport process monitoring, after-sales service capability, after-sales service records, and installation and acceptance records; Chapter 14 Analysis and Improvement, covering monitoring, analysis and improvement of products and the quality management system, complaints and customer feedback, adverse event monitoring, data analysis, corrective and preventive actions, recall management, product information notification, internal audits, and management review.

Attachment 2, the Inspection Guidelines for Implantable Medical Devices under the Medical Device GMP (Draft for Comments), states that based on the GMP and the Appendix for Implantable Medical Devices, the appendix content is integrated with the GMP and transformed into inspection items for implantable medical devices, also divided into critical items (), major items (), and general items (). There are 220 inspection items in total, including 42 critical items, 98 major items, and 80 general items. Inspection types and result determination follow the Inspection Guidelines for the Medical Device GMP. The attached inspection items are also organized into 14 chapters, broadly corresponding to the sterile device guidelines, while highlighting special requirements for implantable medical devices: in organization and personnel, production, technical and quality management personnel for implantable animal-derived and allogeneic medical devices should have relevant knowledge and practical experience in biology, biochemistry, microbiology, medicine, immunology, etc.; in purchasing and raw material management, supplier management for animal-derived and allogeneic raw materials and donors should be strengthened, long-term supply agreements should be signed with designated animal suppliers, and qualification certificates, animal quarantine certificates, animal epidemic prevention certificates and applicable quarantine standards should be retained, while for allogeneic raw materials, proof of legality or ethics committee confirmation from cooperating medical institutions should be retained, donor voluntary donation forms should be kept, donor screening technical requirements should be established, and donor pathogen and necessary serological test reports should be retained; in design and development, for implantable medical devices containing allogeneic materials, animal-derived materials or bioactive substances with biosafety risks, biosafety validation of relevant materials and bioactive substances should be conducted and documented, and the use of additives and control of impurities (such as residual monomers and small molecule residues) in manufacturing processes should be validated and documented, while active implantable medical devices should minimize risks related to energy use, especially insulation, leakage and overheating; in verification and validation, effective methods should be used to inactivate and remove viruses and other infectious pathogens related to biosafety, and the effectiveness of the process should be confirmed; in production management, implantable medical devices should be marked with the manufacturer’s name or trademark, batch code (batch number) or serial number to ensure traceability, and manufacturers of animal-derived and allogeneic implantable medical devices should provide effective safeguards for donor control, protection, testing and processing, develop process documents for virus and other infectious pathogen inactivation or removal, and establish procedures and records for disposal of waste animal and human tissues; in sales and after-sales service, enterprises should retain product sales records and require agents or distributors to retain medical device distribution records; in analysis and improvement, enterprises should establish documented provisions for analyzing and studying retrieved implantable medical devices, and after obtaining retrieved implantable medical devices, analyze and study them to understand information on effectiveness and safety and use it to improve product quality and safety.

Public comments are now invited. Relevant organizations and individuals are requested to send the comment feedback forms (Attachments 3 and 4) to mdgmp@cfdi.org.cn. Please indicate “Feedback on the Inspection Guidelines for Sterile Medical Devices under the Medical Device GMP” or “Feedback on the Inspection Guidelines for Implantable Medical Devices under the Medical Device GMP” in the email subject line. The deadline for comments is October 8, 2026.