The last time the China GMP were completely overhauled was in 2014. NMPA published the new draft “Medical Device Manufacturing Quality Management Standards” on January 15, 2025, for feedback. Feedback needs to be submitted by February 14, 2025.
The proposed revision aligns more closely with the internationally recognized ISO 13485 standard, establishing risk-based GMP principles. With more detailed regulations, the document expands from 82 provisions in 2014 to 131 provisions and incorporates nearly a decade of NMPA experience in medical device GMP inspection. Also, it defines various terms more precisely, making it more practical for implementation.
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Summary of the New GMP
The draft sets comprehensive requirements for medical device manufacturers, emphasizing quality, risk management, and compliance across all lifecycle stages. By establishing rigorous systems for personnel, facilities, production, and post-market management, it aims to foster industry accountability and continuous improvement. Below is a summary of the document’s key provisions, organized by chapter:
Chapter 1: General Provisions
- Purpose and Basis: The document is based on regulations such as the Regulations on the Supervision and Administration of Medical Devices, to ensure the safety and effectiveness of medical devices.
- Scope of Application: The guidelines apply to registrants, filers, and contracted manufacturers throughout the product lifecycle, including design, production, sales, and after-sales.
- Quality Management System (QMS): Companies must establish and maintain a QMS suitable for their products, covering outsourced production and inspections.
- Risk Management: Risk management should span the entire lifecycle, with control measures proportionate to the associated risks.
- Integrity and Honesty: Enterprises must operate truthfully, avoiding deceptive practices.
Chapter 2: Quality Assurance and Risk Management
- Quality Objectives: Companies must set clear objectives to ensure product safety, efficacy, and quality control across all stages, from design to use.
- Resource Allocation: Sufficient resources, including skilled personnel, facilities, and equipment, must be provided.
- Quality Assurance: A robust quality assurance system should ensure:
- Compliance with regulations during design, production, and quality control.
- Clear management responsibilities.
- Proper use of raw materials and controls for intermediate products.
- Validation and verification of processes.
- Controlled release of each product batch after review.
- Monitoring of outsourced activities.
- Change Control: Changes impacting product safety, efficacy, or quality must undergo risk-based evaluation and approval.
- Continuous Improvement: Measures such as corrective actions, risk reviews, and management assessments should promote continuous quality improvement.
- Quality Risk Management: A risk management framework must assess and mitigate risks throughout the product lifecycle.
Chapter 3: Organization and Personnel
- Organizational Structure: Enterprises must have an organization aligned with production needs, with clearly defined roles and responsibilities. Quality and production management leaders cannot hold overlapping roles.
- Quality Management Department: This department must operate independently, have veto power over product quality, and participate in activities affecting quality.
- Key Personnel:
- Enterprise Leader: Bears ultimate responsibility for product safety and quality.
- Management Representative: Must have relevant qualifications and experience, ensuring compliance with regulations and QMS operation.
- Quality Management Leader: Must have a medical device-related background and oversee quality assurance, investigations, and post-market quality management.
- Production Management Leader: Oversees adherence to production processes, record accuracy, and employee training.
- Release Auditor: Reviews and approves product batches for release.
- Training: Employees must undergo training suited to their roles, and training effectiveness should be evaluated.
- Health Management: Companies should manage the health of personnel involved in activities affecting product quality.
Chapter 4: Facilities and Premises
- Design and Layout: Facilities must be designed to minimize contamination, confusion, and errors while allowing ease of cleaning and maintenance.
- Production and Storage Areas:
- Production areas should be spacious and, when necessary, segregated to prevent cross-contamination.
- Storage areas must accommodate materials and products under appropriate conditions and comply with safety regulations for hazardous materials.
- Clean Production Environment: Areas requiring cleanliness should maintain proper air pressure differentials to prevent contamination.
- Documentation: Detailed documentation, such as facility blueprints and maintenance records, must be maintained.
Chapter 5: Equipment
- General Requirements: Equipment and instruments must match production needs and remain in good working condition. Their design should facilitate operation, cleaning, and maintenance.
- Equipment Documentation: Companies must maintain records for procurement, installation, validation, and maintenance.
- Operating Procedures: Instructions and records for key equipment must ensure proper use, maintenance, and traceability.
Chapter 6: Materials Management
- Procurement Control: Companies must evaluate and approve suppliers to ensure raw material quality.
- Acceptance and Storage: Materials should be inspected upon receipt and stored under conditions preventing deterioration.
- Material Identification and Traceability: Distinct labels must identify materials at all stages, ensuring traceability.
Chapter 7: Production Management
- Process Controls: Production must follow validated processes and approved procedures to ensure consistent quality.
- Record-Keeping: Complete and accurate production records are essential for traceability.
- Contamination Prevention: Measures must prevent contamination during production, particularly for sterile products.
- Product Inspection: Final products must undergo inspection, with non-conforming products appropriately handled.
Chapter 8: Quality Control
- Testing and Inspection: Testing must follow approved methods, with records documenting results.
- Laboratory Requirements: Quality control laboratories should have appropriate equipment, facilities, and trained personnel.
- Dealing with Non-Conformance: Non-conforming products must be segregated, investigated, and appropriately addressed.
Chapter 9: Product Release
- Release Process: Products can only be released after thorough review and approval by designated personnel.
- Batch Records: Detailed batch records should confirm compliance with specifications.
Chapter 10: Post-Market Management
- Adverse Event Monitoring: Companies must collect, monitor, and report adverse events associated with their products.
- Recall and Corrective Actions: Effective procedures should address defective products and implement corrective actions.
- Customer Feedback: Systems for handling complaints and feedback must be in place to improve product quality.
Chapter 11: Outsourced Activities
- Supplier and Contractor Oversight: Companies remain responsible for ensuring that outsourced activities comply with quality requirements.
Chapter 12: Documentation Management
- Documentation System: A comprehensive documentation system must support all aspects of production and quality management.
- Record Retention: Records must be retained for specified durations, ensuring traceability and compliance.
Chapter 13: Supervision and Inspection
- Internal Audits: Regular internal audits should evaluate QMS effectiveness.
- Regulatory Inspections: Companies must cooperate with inspections by regulatory authorities and implement corrective measures as required.