Analysis of Medical Device Production Quality Management Practice(Part 7)-Industry dynamics-Anji Wande Medical Products Co., Ltd.

Analysis of Medical Device Production Quality Management Practice(Part 7)

Release time：2025-10-16

Design transfer requirements significantly strengthened; risk management integrated throughout the design and development process

Chapter 7 "Design and Development" has undergone systematic optimization. This chapter expanded from 10 articles in the original version to 11 articles, significantly refining and strengthening the management requirements for the entire medical device design and development process.

I. Structural Optimization and Deepened Requirements

Article reorganization and expansion: Increased from 10 to 11 articles, making the structure more systematic and complete.

Specification of requirements: Requirements for each stage of design and development are more explicit and specific.

Strengthened risk management: Emphasizes that risk management runs through the entire design and development process.

II. In-Depth Analysis of New Key Requirements

1.Systematic Requirements for Design and Development Control Procedures (Article 46)

Clear phase division: Requires clear division of design and development stages.

Whole-process control: Stipulates requirements for the entire process including planning, input, output, verification, validation, transfer, change, and review.

Strengthened document control: Emphasizes requirements for controlling related documents.

2.Independent Article for Design and Development Risk Management (Article 47)

Integration throughout the process: Requires integrating risk management from design and development through to product realization.

Method and tool requirements: Requires using risk management methods and tools to carry out activities.

Record retention: Emphasizes retaining relevant records.

3.Specification of Design and Development Planning Requirements (Article 48)

Detailed planning requirements: Requires specifying the specific activities needed at each stage.

Interface management: Determines the activities and interfaces of different departments at various stages.

Dynamic management: Requires regular review and updating.

4.Significant Strengthening of Design Transfer Requirements (Article 51)

Commercial production orientation: Ensures design output is suitable for commercial production.

Focus on key processes: Focuses on the identification and validation of key processes and special processes.

Comprehensive requirements: Covers production environment, raw material control, production processes, and quality control.

III. Comparative Analysis of Management Requirements

Management Dimension	2014 Version Requirement	2025 Revised Draft Requirement	Significance of Change
Risk Management	General Requirement	Independent clause, whole-process requirement	More systematic risk control
Design & Dev. Plan	Basic Requirement	Specific activities & outputs for each stage	More refined plan management
Design Transfer	Principle Requirement	Specific commercial production requirements	Emphasizes industrial implementation
Document Management	Maintain Records	Establish complete design & development documents	Enhanced traceability requirements
Change Management	Identify & Record	Assess impact, verify & validate	Stricter change control

IV. Impact on Enterprises and Implementation Suggestions

Immediate Action Items:

1.Restructure Design and Development Processes

Re-evaluate the completeness of existing design and development processes.

Define stage divisions and output requirements.

Establish a design and development plan management system.

2.Strengthen the Risk Management System

Deeply integrate risk management into each stage of design and development.

Establish a library of risk management tools and methods.

Improve the risk management record system.

3.Build Design Transfer Capability

Establish a design transfer assessment mechanism.

Strengthen the identification of key processes and special processes.

Improve verification of suitability for commercial production.

Medium to Long-Term Construction Focus:

1.Design and Development Platform Construction

Establish a unified design and development management platform.

Realize whole-process management of design data.

Strengthen inter-departmental collaboration and interface management.

2.Risk Management Culture Development

Enhance company-wide risk management awareness.

Establish a risk knowledge base and case library.

Conduct regular risk management training.

3.Design Quality Improvement

Establish a design quality evaluation system.

Strengthen design verification and validation capabilities.

Optimize the design change management process.

The revision of Chapter 7 reflects a significant upgrade in the philosophy of design and development management: shifting from focusing on project delivery to emphasizing whole-process control, from technical realization to risk management, and from laboratory research to industrial implementation. Enterprises need to establish a more systematic and refined design and development management system to ensure design quality while also guaranteeing product manufacturability and commercial feasibility. It is recommended that enterprises initiate the assessment and upgrade of their design and development management systems as soon as possible to be fully prepared for the implementation of the new regulation.

Attached at the end is a comparison of Chapter 7 content between the old and new versions of the "Medical Device Production Quality Management Guifan".

Medical Device Production Quality Management Guifan (Revised Draft for Comments)	Medical Device Production Quality Management Guifan (2014 No. 64)
Chapter 7: Design and Development	Chapter 6: Design and Development
Article 46 [General Requirements] Enterprises shall establish design and development control procedures, divide the design and development stages, specify activities such as design and development planning, input, output, verification, validation, transfer, change, and review, and related document control requirements, and implement planning and control for the entire process of medical device design and development.	Article 28 Enterprises shall establish design control procedures and document them, and implement planning and control for the medical device design and development process.
Article 47 [Design and Development Risk Management Requirements] Enterprises shall integrate risk management throughout the entire process from design and development to product realization, establish relevant requirements and document them, use risk management methods and tools to carry out risk management activities, and retain relevant records.	Article 38 Enterprises shall, throughout the product realization process including design and development, establish risk management requirements and document them, and maintain relevant records.
Article 48 [Design and Development Plan] Enterprises shall plan the design and development according to product characteristics, specifying the specific activities required for stages such as design input, design output, design transfer, design verification, and validation. A design and development plan shall be formulated, specifying the verification, validation, transfer, change, and review activities and output requirements applicable to each stage, determining the activities and interfaces of various departments at different stages, and clarifying responsibilities and division of labor. The design and development plan shall be reviewed and approved, and regularly reviewed during implementation.	Article 39 When conducting design and development planning, the stages of design and development and the activities such as review, verification, validation, and design transfer for each stage shall be determined. The design and development activities and interfaces of various departments shall be identified and determined, clarifying responsibilities and division of labor.
Article 49 [Design and Development Input] Design and development input shall at least include requirements determined based on user needs and intended use, such as function, performance, safety, as well as regulations, standards, risk control measures, etc. Design and development input shall be clear, complete, and undergo review and approval.	Article 30 Design and development input shall include the function, performance, and safety requirements specified by the intended use, regulatory requirements, risk management control measures, and other requirements. Design and development input shall be reviewed and approved, and relevant records maintained.
Article 50 [Design and Development Output] Design and development output shall satisfy the input requirements for each stage. Design and development output shall at least include relevant information required for procurement, production, inspection, use, and service, as well as product technical requirements, etc. Design and development output shall be verified and approved.	Article 31 Design and development output shall satisfy the input requirements, including relevant information required for procurement, production, and service, product technical requirements, etc. Design and development output shall be approved, and relevant records maintained.
Article 51 [Design and Development Transfer] Enterprises shall, considering product characteristics, carry out transfer activities from design and development to production, ensuring that the production environment, raw material control, production process, and quality control-related procedures derived from the design output are verified and suitable for commercial production. Design and development transfer shall focus on the identification, verification, and validation of key processes and special processes.	Article 32 Enterprises shall carry out design and development transfer activities during the design and development process, so that the design and development output can be verified before becoming the final product specification, ensuring the design and development output is suitable for production.
Article 52 [Design and Development Review] Enterprises shall conduct reviews at appropriate stages of design and development, continuously evaluate the ability of the design and development output to meet input requirements, identify problems, and propose necessary improvement measures.	Article 33 Enterprises shall arrange reviews at appropriate stages of design and development, and maintain records of the review results and any necessary actions.
Article 53 [Design and Development Verification] Enterprises shall perform design and development verification to ensure that the design and development output meets the input requirements. Relevant documents shall be retained, including at least the verification protocol, verification report, verification results and conclusions, and verification process records.	Article 34 Enterprises shall perform design and development verification to ensure that the design and development output meets the input requirements, and maintain records of the verification results and any necessary actions.
Article 54 [Design and Development Validation] Enterprises shall perform design and development validation to ensure the product meets the specified use requirements or intended use requirements. Validation may use clinical evaluation or performance evaluation. When conducting clinical trials, the requirements of medical device clinical trial regulations shall be met.	Article 35 Enterprises shall perform design and development validation to ensure the product meets the specified use or intended use requirements, and maintain records of the validation results and any necessary actions. Article 36 Validation may use clinical evaluation or performance evaluation. When conducting clinical trials, the requirements of medical device clinical trial regulations shall be met.
Article 55 [Design and Development Change] Enterprises shall identify design and development changes and assess the impact of the changes. When necessary, design and development changes shall be verified and validated, and approved before implementation.	Article 37 Enterprises shall identify design and development changes and maintain records. When necessary, design and development changes shall be reviewed, verified, and validated, and approved before implementation. When changes in selected materials, components, or product functions may affect the safety and effectiveness of the medical device product, the risks potentially arising from the changes shall be assessed, and measures shall be taken to reduce the risks to an acceptable level when necessary, while also complying with relevant regulatory requirements.
Article 56 [Design and Development Documentation] Enterprises shall establish product design and development documentation, including records created or referenced during the design and development process, to demonstrate compliance with design and development requirements and ensure the traceability of the final output process of successive design and development cycles and its related activities.

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