18069717650
0572-5528222 0572-5528378
18069717650
0572-5528222 0572-5528378
Release time：2025-10-22
Supplier classification management requirements clarified; whole lifecycle material control becomes a new focus.Chapter 8 "Purchasing and Material Management" has undergone significant expansion and deepening. This chapter increased from 6 articles in the original version to 10 articles, putting forward more systematic and detailed requirements for medical device purchasing and material management.
I. Structural Optimization and Scope Expansion
Chapter expansion: Increased from 6 to 10 articles, adding 4 new clauses.
Refined requirements: Put forward specific operational requirements for supplier management and material control.
Expanded scope: Extended from purchasing management to the whole lifecycle management of materials.
II. In-Depth Analysis of New Key Requirements
1.Clarified Supplier Classification Management Requirements (Article 58)
Diversified classification basis: Requires classification management based on factors such as the degree of impact on the product, process complexity, and impact on quality and safety.
Dynamic management: Considers different situations such as first-time supply and continuous supply.
Differentiated control: Provides a basis for implementing differentiated management.
2.Institutionalized Regular Supplier Evaluation (Article 60)
Comprehensive evaluation dimensions: Include quality, technical level, delivery capability, etc.
Risk response mechanism: Requires suspending procurement from suppliers with major deficiencies and analyzing the risks.
Continuous monitoring: Establishes a mechanism for continuous evaluation of supplier performance.
3.Systematic Material Management System (Articles 64, 65)
Whole-process control: Ensures materials are correctly stored, issued, used, and shipped.
FIFO principle: Clarifies the principle for issuing and using raw materials.
Re-inspection requirement: Raw materials exceeding the storage period must undergo re-inspection and be deemed qualified before use.
4.Preemptive Supplier Change Management (Article 66)
Advance notification requirement: Major changes require advance notification.
Impact assessment: Requires assessing the impact of changes on product quality.
On-site audit: Requires on-site audits when necessary.
III. Comparative Analysis of Management Requirements
Management Dimension | 2014 Version Requirement | 2025 Revised Draft Requirement | Significance of Change |
Supplier Management | Basic audit requirements | Classification management, regular evaluation, change management | More systematic management |
Quality Agreement | Major raw material suppliers | Major raw material and service suppliers | Expanded scope |
Material Management | Not explicitly required | Whole lifecycle management, FIFO, re-inspection | More specific requirements |
Purchase Acceptance | Inspection or verification | Specified acceptance environment, sampling rules, acceptance criteria | Stricter requirements |
File Management | Basic requirements | Establish complete quality files, including multiple document types | Enhanced traceability requirements |
IV. Impact on Enterprises and Implementation Suggestions
Immediate Action Items:
1.Restructure Supplier Management System
Establish supplier classification standards and a tiered management system.
Develop supplier audit and evaluation criteria.
Improve the management of the Approved Supplier List.
2.Improve Quality Agreement System
Sign quality agreements with major suppliers.
Clarify technical requirements, acceptance criteria, and quality responsibilities.
Establish supplier quality files.
3.Optimize Material Management Processes
Establish a whole lifecycle management system for materials.
Implement FIFO management.
Develop procedures for re-inspecting overdue materials.
Medium to Long-Term Construction Focus:
1.Digital Supply Chain Management
Establish a Supplier Relationship Management (SRM) system.
Realize informatization of purchasing and material management.
Develop supplier performance evaluation tools.
2.Risk Early Warning Mechanism Construction
Establish a supplier risk monitoring and early warning mechanism.
Develop contingency plans for abnormal supplier situations.
Improve supply chain continuity assurance measures.
3.Extension of Quality Management System
Incorporate suppliers into the quality management system.
Establish a supplier quality improvement mechanism.
Implement supplier quality capability enhancement programs.
The revision of Chapter 8 reflects a significant upgrade in the philosophy of purchasing and material management: shifting from simple purchasing operations to comprehensive supply chain management, from price orientation to quality orientation, and from single transactions to long-term cooperation.
Enterprises need to establish a more systematic and refined purchasing and material management system to ensure the quality and stability of the supply chain. It is recommended that enterprises initiate the assessment and upgrade of their purchasing and material 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 8 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 8: Purchasing and Material Management | Chapter 7: Purchasing |
Article 57 [General Purchasing Requirements] Enterprises shall establish purchasing management procedures to ensure that purchased raw materials or services comply with specified requirements and are not lower than the relevant requirements of laws, regulations, and mandatory standards. | Article 39 Enterprises shall establish purchasing control procedures to ensure that purchased items comply with specified requirements and are not lower than the relevant provisions of laws and regulations and relevant national mandatory standards. |
Article 58 [Supplier Classification Management] Enterprises shall classify and manage purchased raw materials or services and their suppliers based on the degree of impact of the purchased raw materials or services on the product. Supplier management shall consider factors such as the complexity of the production process for the purchased raw materials or services, the degree of impact on product quality and safety, and whether it is a first-time supply or continuous supply. | Article 40 Enterprises shall determine the method and extent of control applied to purchased items based on their impact on the product. |
Article 59 [Supplier Qualification Audit] Enterprises shall establish a supplier audit system, define the criteria and methods for supplier selection, evaluation, and re-evaluation, and establish an Approved Supplier List based on the audit evaluation results. Considering product quality risk, raw material usage, and the degree of impact on product quality, conduct on-site audits of raw material and service suppliers when necessary. | Article 41 Enterprises shall establish a supplier audit system and shall conduct audit evaluations of suppliers. Conduct on-site audits when necessary |
Article 60 [Regular Supplier Evaluation] Enterprises shall conduct regular comprehensive evaluations of suppliers, reviewing and analyzing the quality, technical level, delivery capability, etc., of the supplied materials or services. If an evaluation identifies major deficiencies in a supplier, procurement shall be suspended, the risk posed by the relevant deficiencies to the product shall be promptly analyzed, and corresponding measures shall be taken when necessary. | |
Article 61 [Purchasing Quality Agreement and Quality File] Enterprises shall sign quality agreements with major raw material and service suppliers, clarifying the technical requirements, acceptance criteria for the purchased raw materials or services, and the quality responsibilities of both parties. Enterprises shall establish quality files for major raw material or service suppliers. The file content shall include: purchase contracts or quality agreements, list of purchased items, supplier qualification documents, product technical requirements or quality standards, acceptance criteria, regular supplier audit reports, as well as the results of evaluations, selection, monitoring, and re-evaluation of supplier capability or performance, and records of any necessary actions arising from these activities. | Article 42 Enterprises shall sign quality agreements with major raw material suppliers, clarifying the quality responsibilities borne by both parties. |
Article 62 [Purchasing Information] Enterprises shall define purchasing information and purchasing requirements, including the category, acceptance criteria, specification/model, procedures, drawings, etc., of the purchased raw materials or services. Shall retain purchasing records, including purchase contracts, material or service lists, inspection reports, etc. Purchasing records shall be authentic, accurate, complete, and traceable. | Article 43 When purchasing, shall clearly define purchasing information, clearly stating purchasing requirements, including the category, acceptance criteria, specification/model, procedures, drawings, etc., of the purchased items. Shall establish purchasing records, including purchase contracts, raw material lists, supplier qualification documents, quality standards, inspection reports, and acceptance criteria, etc. Purchasing records shall meet traceability requirements. |
Article 63 [Purchase Acceptance] Enterprises shall establish a raw material incoming acceptance system, and inspect, test, or verify purchased raw materials to ensure requirements are met. Raw material incoming acceptance shall follow sampling rules in the appropriate environment and comply with acceptance criteria requirements. | Article 44 Enterprises shall inspect or verify purchased items to ensure they meet production requirements. |
Article 64 [Material and Finished Product Management] Enterprises shall establish corresponding management systems to ensure that raw materials, intermediate products, and finished products, etc., can be correctly stored, issued, used, and shipped, preventing contamination, cross-contamination, mix-ups, and errors. Related activities shall have records. | |
Article 65 [Material Re-inspection] The issuance and use of enterprise raw materials shall generally follow the first-in, first-out principle. Raw materials exceeding the storage period shall be re-inspected and can only be used after being assessed as conforming to specifications. | |
Article 66 [Supplier System Change Management] When changes in the production conditions, specifications/models, drawings, production processes, quality standards, inspection methods, etc., of major raw materials may affect product quality, the enterprise shall require the supplier to notify it in advance of such changes, assess the scope and degree of the change's impact on product quality, take corresponding measures to avoid product quality risks caused by the change when necessary, and conduct on-site audits of the supplier. |
