Implementation Date: November 1, 2026
Core Changes: Expanded from 10 chapters to 15 chapters, and the number of clauses increased from about 80 to 132.
On November 4, 2025, the National Medical Products Administration (NMPA) issued the new version of the Medical Device Production Quality Management Specification (hereinafter referred to as the "New Specification"), which will be officially implemented on November 1, 2026. This marks a major revision since the release of the 2014 old version. Yinso organized a study of the New Specification at the first time, and now sorts out its core changes for the reference of colleagues in the industry.
I. Overall Framework: Expanded Chapters with a More Comprehensive System
| Comparison Dimension | 2014 Version | 2026 Version |
|---|
| Total Number of Chapters | 10 | 15 |
| Total Number of Clauses | About 80 | 132 |
| Newly Added Chapters | — | Quality Assurance, Validation and Verification, Contract Manufacturing and Outsourced Processing |
On the basis of retaining the core chapters including Organization and Personnel, Premises and Facilities, Equipment, Document Control, Design and Development, Procurement, Production Management, Quality Control, Sales and After-sales Service, and Non-conforming Product Control, the New Specification adds three independent chapters, enabling the quality management system to cover the entire product life cycle.
II. Interpretation of the Three Newly Added Chapters
1. Quality Assurance
Core Requirements: Establish a quality assurance system covering the entire product life cycle; Standardize management review and internal audit; Integrate adverse event monitoring, data analysis and continuous improvement into the closed-loop system.
Interpretation: Shifting from "quality control" to "quality assurance", the New Specification emphasizes proactive prevention and continuous improvement. Yinso has established a sound quality assurance system and obtained the ISO 13485:2016 certification, laying a solid foundation for sustained compliance.
2. Validation and Verification
Core Requirements: Clarify key processes such as process validation, sterilization validation and packaging validation; Emphasize the continuous maintenance of validation status and re-validation; Establish the management of master validation plans and validation protocols.
Interpretation: Validation and verification have been upgraded from a "supplementary requirement" to an "independent chapter", reflecting the high importance attached to process effectiveness. As a medical blister packaging enterprise, Yinso has sustained investment in seal performance validation, sterilization compatibility validation and other aspects to ensure that the packaging system meets the requirements of sterile barrier systems.
3. Contract Manufacturing and Outsourced Processing
Core Requirements: Integrate contract manufacturing and outsourced processing into the quality management system; Clarify the primary responsibilities of registrants and the division of duties of contract manufacturers; Establish a dynamic supplier management mechanism.
Interpretation: In combination with the medical device registrant system, the New Specification further consolidates the quality responsibilities in contract manufacturing. As a supporting supplier, Yinso will continuously optimize the supplier management system and safeguard quality and safety together with customers.
III. Key Revision Points of Major Clauses
1. Design and Development
Main Changes: Risk management runs through the entire process of design and development; Refine the requirements for design transfer, design verification and design change; Emphasize the connection between design and production.
2. Procurement and Material Management
Main Changes: Strengthen the classified management and dynamic evaluation of suppliers; Clarify the traceability requirements for critical materials; Add quality control requirements for outsourced processing.
3. Production Management
Main Changes: Refine the requirements for environmental control and cleanroom management; Strengthen the completeness and traceability of batch production records; Clarify the management of process control and process parameters.
4. Quality Control
Main Changes: Standardize the release review procedures and responsibilities; Refine the management requirements for inspection records; Emphasize the control of non-conforming products and corrective and preventive actions.
IV. Core Orientation: Three Transformations
From “quality control” to “quality assurance” (proactive prevention)
From “partial coverage” to “full product life-cycle management”
From “compliance-driven” to “risk-based performance & quality governance”
V. Recommendations for Industry Colleagues
There is a transition period before the implementation on November 1, 2026. Relevant enterprises are recommended to:
Conduct gap analysis — Evaluate the compliance of the existing system item by item against the 132 requirements of the New Specification.
Improve the three newly added sections — Focus on the implementation of requirements in the three newly added chapters of Quality Assurance, Validation and Verification, and Contract Manufacturing and Outsourced Processing.
Strengthen training for key positions — Organize systematic training for personnel in key positions such as quality managers, production managers and management representatives.
Conduct self-inspection and rectification in advance — Optimize the system during the transition period to ensure compliance with the New Specification on schedule.
Conclusion
The implementation of the New Specification is an important measure to promote the high-quality development of the medical device industry. Adhering to the corporate philosophy of "Quality and Service as the Soul", Yinso is equipped with a Class 10,000 cleanroom and holds the ISO 13485:2016 certification. We are committed to providing safe and reliable blister packaging solutions for the medical device industry. We will continue to follow the regulatory dynamics and work with colleagues in the industry to jointly safeguard the quality and safety line of medical devices.
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