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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Why It Matters
The proposed regulations apply to medical device registrants, record holders, and contract manufacturers in all lifecycle activities, including design and development, production, sales, and after-sales services. It emphasizes that enterprises must assume primary responsibility for the quality and safety of medical devices. Companies are required to establish quality objectives that comply with medical device quality management requirements. These objectives must systematically integrate all safety, efficacy, and quality control requirements into the entire process of product design and development, production, quality control and product release, storage and transportation, and usage to ensure quality goals are understood and achieved.
The draft also introduces specific provisions for enterprise digitalization systems to meet regulatory requirements for digitalized production management. For example, in the chapter on documentation and data management, the draft requires that when using digital systems to generate electronic records or data, enterprises must ensure the authenticity, accuracy, completeness, timeliness, and traceability of such records, in compliance with relevant requirements.
Additionally, the draft mandates that enterprises determine the scope and extent of validation or verification based on risk assessment to demonstrate that critical elements of facilities, equipment, operations, and product realization processes are effectively controlled. It includes detailed provisions on facility and equipment qualification, process validation, cleaning validation, and change validation. Enterprises must establish a master validation plan and develop specific validation or verification protocols based on the targeted validation subject.
Furthermore, the draft refines regulations on contract manufacturing. It stipulates that the quality management system of the contracting party must cover the entire lifecycle of the medical device. Meanwhile, the contract manufacturer’s quality management system must include all aspects related to the entrusted production activities. Both parties must establish an effective communication mechanism to ensure the seamless integration and effective operation of their respective quality management systems.
Key Revisions
Structural Changes
- Expanded from 13 chapters (84 articles) to 15 chapters (131 articles).
- Added three new chapters: Quality Assurance and Risk Management, Validation and Verification, and Contract Manufacturing & Outsourcing.
- Removed the chapter on Nonconforming Product Control, either merging it with other sections or eliminating redundant provisions.
- Modified, refined, and supplemented existing chapters.
Content Modifications
Although the revision significantly expands the document’s scope, most updates align with current regulatory practices rather than introducing entirely new requirements. The revised regulations are scheduled for implementation in 2025.
Chapter 1: General Provisions (Minor Revisions)
- Removed regulatory numbering to prevent frequent updates due to future numbering changes.
- Broadened the scope from “manufacturers” to “registrants, record holders, and manufacturers”, emphasizing their responsibility throughout the product lifecycle.
- Included regulations on contract manufacturing, outsourcing, and entrusted inspections.
- Introduced the requirement for corporate integrity and credibility.
Chapter 2: Quality Assurance and Risk Management (New Chapter)
- Mandates enterprises to establish quality objectives and allocate sufficient resources.
- Requires the development of a quality assurance system and change control mechanisms.
- Emphasizes continuous improvement, quality risk management, and periodic reviews.
Chapter 3: Organization and Personnel (Major Revision)
- Removed the requirement for an organizational structure chart.
- Requires enterprises to establish a quality department and appoint key personnel:
- Company leader
- Management representative
- Production manager
- Quality manager
- Product release auditor
- Defined their responsibilities clearly.
- Added requirements for training and health management.
- Ensures production adheres to mandatory standards and technical specifications.
Chapter 4: Facilities and Premises (Minor Revision)
- Strengthened production line separation requirements.
- Added provisions on facility maintenance, cleanroom standards, digital systems, access control, and documentation of premises.
Chapter 5: Equipment (Minor Revision)
- Expanded requirements for equipment documentation, labeling, and requalification of instruments.
Chapter 6: Documentation and Data Management (Minor Revision)
- Enterprises must identify and update regulations in their quality management system.
- Enhanced requirements for electronic record-keeping and data management.
Chapter 7: Design and Development (Minor Revision)
- Clarifies development phases and requires a design development plan.
- Stresses identification and validation of critical processes.
- Establishes a design and development documentation system.
Chapter 8: Procurement and Material Management (Major Revision)
- Requires supplier classification and approval processes.
- Introduces regular supplier evaluations and the establishment of supplier quality records.
- Strengthens controls on raw materials, intermediates, and finished products.
- Requires reinspection and change management for suppliers.
Chapter 9: Validation and Verification (New Chapter)
- Expands requirements for:
- Facility and equipment qualification
- Process validation
- Cleaning validation
- Change validation
- Revalidation and requalification
- Validation implementation processes
- Software validation
Chapter 10: Production Management (Minor Revision)
- Strengthens packaging material control.
- Batch production records must reflect material balance or usage tracking.
- Introduces line clearance management, deviation handling, and Unique Device Identification (UDI) requirements.
- Defines standards for co-line production, continuous production, and production resumption.
Chapter 11: Quality Control and Product Release (Major Revision)
- Adds new requirements for:
- Inspector qualifications
- Sample management
- Environmental monitoring
- Nonconforming product handling
- Enhances testing procedures, methods, and documentation.
- Introduces product release and entrusted inspection requirements.
Chapter 12: Contract Manufacturing & Outsourcing (New Chapter)
- Requires the contract giver’s quality management system to cover the entire lifecycle of the medical device.
- The contract manufacturer must ensure its quality management system aligns with production responsibilities.
- Mandates a communication mechanism between contracting parties to ensure an integrated and functional quality system.
- Includes provisions for contract research and development as well as outsourcing capability assessment.
Chapter 13: Sales and After-Sales Services (Minor Revision)
- Reduced from five to three articles.
- Emphasizes compliance with laws, regulations, and standards.
- Introduces requirements for product serial numbers and UDI tracking.
Chapter 14: Analysis and Improvement (Minor Revision)
- Details analysis and improvement measures based on existing regulatory requirements.
Chapter 15: Supplementary Provisions (Major Revision)
- Expanded terminology definitions from 4 to 35 terms, including:
- Validation
- Verification
- Critical processes
- Special procedures
- Official implementation date set for 2025.