Guidelines for Inspection of Good Manufacturing Practice for Medical Devices
To strengthen the supervision and management of medical device production, guide drug regulatory authorities in conducting medical device production inspections for medical device registrants, record-holders, and contract manufacturers (hereinafter referred to as "enterprises"), these guidelines are formulated in accordance with the Good Manufacturing Practice for Medical Devices (hereinafter referred to as the "GMP").
I. Scope of Application
These guidelines apply to manufacturing license verification (including changes and renewals) and all types of post-market supervisory inspections conducted on enterprises.
II. Inspection Items and Classification
Based on the importance of each GMP clause in the quality management system and the degree of quality and safety risk posed by non-conformities, clauses are classified into three levels: Critical Items (***), Major Items (**), and General Items (*). There are 200 inspection items in total, including 39 critical items, 88 major items, and 73 general items.
- Critical Items are items that have a significant impact on the operation of the product quality management system, and whose non-conformity will lead to product quality and safety risks.
- Major Items are items that have a considerable impact on the operation of the product quality management system, and whose multiple non-conformities combined will lead to product quality and safety risks.
- General Items are items that have a certain impact on the operation of the product quality management system, and whose non-conformity may lead to product quality and safety risks.
III. Inspection Types and Result Determination
(1) Manufacturing License Verification
Manufacturing license verification is the examination conducted by drug regulatory authorities during the review of medical device manufacturing license applications (including changes and renewals) to determine whether applicants possess the conditions for engaging in medical device production activities. Verification conclusions are categorized as "Passed Verification," "Failed Verification," or "Rectification and Re-inspection."
Determination principles for manufacturing license verification:
Where no critical or major non-conformities are found, and the number of general non-conformities is fewer than 5, the verification conclusion shall be "Passed Verification." Non-conformities found during verification shall be self-rectified by the enterprise and explained in the annual self-inspection report.
Where any of the following circumstances exist, the verification conclusion shall be "Failed Verification":
- Fraudulent or deceptive practices;
- 3 or more critical non-conformities;
- Combined total of 10 or more critical and major non-conformities;
- Total of 20 or more non-conformities.
Situations not classified as "Passed" or "Failed" shall be determined as "Rectification and Re-inspection." If the enterprise completes rectification within the prescribed time limit and follow-up inspection confirms compliance, the final conclusion shall be "Passed Verification"; if rectification materials are not submitted within the prescribed time or follow-up inspection finds inadequate rectification, the final conclusion shall be "Failed Verification."
(2) Post-Market Supervisory Inspection
Post-market supervisory inspections are divided into full-scope inspections and partial-scope inspections based on coverage. Inspection conclusions are categorized as "No Non-conformities Found," "Self-Rectification," "Production Suspension for Rectification," or "Rectification within Time Limit."
1. Full-Scope Inspection
A full-scope inspection covers all applicable GMP items.
Determination principles:
(1) No non-conformities found: conclusion is "No Non-conformities Found."
(2) No critical or major non-conformities found, with fewer than 5 general non-conformities: conclusion is "Self-Rectification."
(3) Where any of the following exist, the conclusion is "Production Suspension for Rectification":
- Fraudulent or deceptive practices;
- 3 or more critical non-conformities;
- Combined total of 10 or more critical and major non-conformities;
- Total of 20 or more non-conformities.
The enterprise shall be required to suspend production until all non-conformities are rectified and verified through follow-up inspection.
(4) Situations not falling under the above categories: conclusion is "Rectification within Time Limit."
2. Partial-Scope Inspection
A partial-scope inspection covers selected GMP chapters based on inspection plans or work programs.
- For self-manufacturing registrants/record-holders: shall cover at least Quality Assurance, Procurement and Raw Material Management, Production Management, Quality Control and Product Release, and Analysis and Improvement.
- For entrusting registrants/record-holders: shall cover at least Quality Assurance, Organization and Personnel, Quality Control and Product Release, Contract Manufacturing and Outsourcing, and Analysis and Improvement.
- For contract manufacturers: shall cover at least Quality Assurance, Procurement and Raw Material Management, Production Management, Quality Control and Product Release, and Analysis and Improvement.
Inspection Result Determination Table
| Non-conformities | License Verification | Post-Market Inspection | |||
|---|---|---|---|---|---|
| Total | Critical | Major | General | ||
| 0 | 0 | 0 | 0 | Passed | No Non-conformities |
| <5 | 0 | 0 | <5 | Passed | Self-Rectification |
| <20 | <=2 | <8 | -- | Rectification & Re-inspection | Time-Limited Rectification |
| <20 | 1 | <9 | -- | Rectification & Re-inspection | Time-Limited Rectification |
| <20 | 0 | <10 | -- | Rectification & Re-inspection | Time-Limited Rectification |
| -- | >=3 | -- | -- | Failed | Suspension |
| -- | -- | >=10 | -- | Failed | Suspension |
| >=20 | -- | -- | -- | Failed | Suspension |
IV. Other Requirements
(1) Drug regulatory authorities shall conduct comprehensive assessment based on the severity of non-conformities and product risks. Where multiple non-conformities are interrelated and may indicate systemic risks in the quality management system, it shall be treated as a critical non-conformity in the "Quality Assurance" chapter. For non-conformities that appear repeatedly in the previous two inspections, the risk level may be elevated by one grade based on specific circumstances.
(2) Where the inspection conclusion is "Production Suspension for Rectification," the medical device registrant or record-holder shall comprehensively assess product quality and safety risks and, if necessary, recall the relevant products.
(3) Matters involving violations of the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Supervision and Administration of Medical Device Production, and other relevant laws, regulations, and rules shall be handled in accordance with the law.
Appendix: GMP Inspection Items
Chapter 1: General Provisions
| No. | Clause | Content | Risk Level | GMP Article |
|---|---|---|---|---|
| 1 | 1.1.1 | The enterprise shall establish and maintain a quality management system appropriate to the medical devices it produces, in accordance with the requirements of this GMP, and ensure its effective operation. The QMS shall cover entrusted R&D, contract manufacturing, outsourced processing, and entrusted testing. | *** | Art. 3 |
| 2 | 1.2.1 | The enterprise shall integrate risk management principles throughout the entire QMS operation process. Control measures adopted shall be commensurate with the risks associated with the products. | ** | Art. 4 |
Chapter 2: Quality Assurance
| No. | Clause | Content | Risk Level | GMP Article |
|---|---|---|---|---|
| 3 | 2.1.1 | The enterprise shall fulfill its primary responsibility for medical device quality and safety, establish quality objectives meeting QMS requirements, systematically implement all requirements for product safety, efficacy, and quality controllability throughout the QMS operation process. | *** | Art. 7 |
| 4 | 2.2.1 | The enterprise shall provide sufficient and qualified personnel, premises, facilities, and equipment to achieve quality objectives. | *** | Art. 8 |
| 5 | 2.2.2 | Personnel at all levels shall participate in activities to achieve quality objectives and bear corresponding responsibilities. | ** | Art. 8 |
| 6 | 2.3.1 | The enterprise shall establish a quality assurance system with complete QMS documentation. | *** | Art. 9 |
| 7 | 2.4.1 | The enterprise shall establish change control procedures, determining the type of change management based on risk assessment and regulatory requirements. | *** | Art. 10 |
| 8 | 2.5.1 | The enterprise shall achieve continuous improvement through quality data monitoring, change management, adverse event monitoring, quality risk management reviews, CAPA, internal audits, and management reviews. | ** | Art. 11 |
| 9 | 2.6.1 | The enterprise shall establish a quality risk management system, assessing quality risks throughout the entire product realization process. | ** | Art. 12 |
| 10 | 2.7.1 | The enterprise shall collect quality risk information throughout the product lifecycle and periodically conduct quality risk management reviews. | * | Art. 13 |
Chapter 3: Organization and Personnel
| No. | Clause | Content | Risk Level | GMP Article |
|---|---|---|---|---|
| 11 | 3.1.1 | The enterprise shall establish an organizational structure appropriate to medical device production, with clear departmental responsibilities and quality management functions. | ** | Art. 14 |
| 12 | 3.1.2 | The heads of production management and quality management departments shall not serve concurrently in each other's roles. | *** | Art. 14 |
| 13-34 | 3.2.1-3.11.1 | Personnel qualification, management representative duties, training requirements, and health management. | *-*** | Art. 15-24 |
Chapter 4: Premises and Facilities
| No. | Clause | Content | Risk Level | GMP Article |
|---|---|---|---|---|
| 35-51 | 4.1.1-4.11.1 | Premises design, layout, environmental controls, cleanroom requirements, storage areas, and facility documentation. | *-*** | Art. 25-35 |
Chapter 5: Equipment
| No. | Clause | Content | Risk Level | GMP Article |
|---|---|---|---|---|
| 52-60 | 5.1.1-5.6.1 | Equipment qualification, maintenance, calibration, records, and re-qualification after major repairs. | *-*** | Art. 36-41 |
Chapter 6: Document and Data Management
| No. | Clause | Content | Risk Level | GMP Article |
|---|---|---|---|---|
| 61-68 | 6.1.1-6.5.1 | QMS documentation, document control procedures, record control, and electronic records/data integrity requirements. | *-*** | Art. 42-46 |
Chapter 7: Design and Development
| No. | Clause | Content | Risk Level | GMP Article |
|---|---|---|---|---|
| 69-87 | 7.1.1-7.12.3 | Design control procedures, risk management, design planning, input/output, transfer, review, verification, validation, change control, documentation, and entrusted design. | *-*** | Art. 47-58 |
Chapter 8: Procurement and Raw Material Management
| No. | Clause | Content | Risk Level | GMP Article |
|---|---|---|---|---|
| 88-105 | 8.1.1-8.10.2 | Procurement control, supplier management, incoming inspection, storage management, and supplier change notification. | *-*** | Art. 59-68 |
Chapter 9: Verification and Validation
| No. | Clause | Content | Risk Level | GMP Article |
|---|---|---|---|---|
| 106-117 | 9.1.1-9.9.1 | Risk-based verification scope, facility/equipment qualification, process validation, special process validation, cleaning validation, revalidation, and computer software validation. | *-*** | Art. 69-77 |
Chapter 10: Production Management
| No. | Clause | Content | Risk Level | GMP Article |
|---|---|---|---|---|
| 118-138 | 10.1.1-10.17.1 | Production process control, batch records, material balance, product identification, labeling, product protection, line clearance, deviation handling, non-conforming product control, traceability, UDI implementation, shared production lines, continuous production, and resumption after shutdown. | *-*** | Art. 78-94 |
Chapter 11: Quality Control and Product Release
| No. | Clause | Content | Risk Level | GMP Article |
|---|---|---|---|---|
| 139-162 | 11.1.1-11.12.4 | Quality control procedures, inspector qualifications, inspection specifications, test methods, sample management, inspection records, equipment management, laboratory environment, investigation of failures, product release procedures, retention samples, and entrusted testing. | *-*** | Art. 95-106 |
Chapter 12: Contract Manufacturing and Outsourcing
| No. | Clause | Content | Risk Level | GMP Article |
|---|---|---|---|---|
| 163-179 | 12.1.1-12.10.2 | QMS coverage for full lifecycle, quality agreements, capability assessment, personnel requirements, production transfer, change management, release procedures for both parties, and outsourcing controls. | *-*** | Art. 107-116 |
Chapter 13: Sales and After-Sales Service
| No. | Clause | Content | Risk Level | GMP Article |
|---|---|---|---|---|
| 180-188 | 13.1.1-13.4.2 | Sales compliance, sales records with traceability, transportation validation, after-sales service, and installation requirements. | *-** | Art. 117-120 |
Chapter 14: Analysis and Improvement
| No. | Clause | Content | Risk Level | GMP Article |
|---|---|---|---|---|
| 189-200 | 14.1.1-14.9.2 | Monitoring and analysis activities, complaint handling, adverse event monitoring, data analysis, CAPA, product recall, information notification, internal audits, and management review. | *-** | Art. 121-129 |
Note
The clause numbering format is X1.X2.X3, where X1 is the chapter number (e.g., 2.1.1 indicates the "Quality Assurance" chapter), X2 is the sequential clause number within the chapter, and X3 is the sequential inspection item number within the clause.