18069717650
0572-5528222 0572-5528378
18069717650
0572-5528222 0572-5528378
Release time：2025-10-14
Equipment management requirements shift from "presence/absence" to "quality/performance," newly added re-confirmation requirements strengthen ongoing compliance. Chapter 5 "Equipment" has undergone systematic changes. This chapter expanded from 5 articles in the original version to 6 articles, putting forward more refined and whole lifecycle requirements for the management of production equipment, inspection instruments, and tooling & fixtures.
I. Structural Optimization and Scope Expansion
Structural reorganization: Integrates equipment management requirements from previously dispersed articles into a systematic chapter structure.
Scope expansion: Explicitly includes tooling and fixtures within the management scope, reflecting control over all elements of production.
Elevated requirements: Upgrades from simple "equipping with devices" requirements to comprehensive requirements for "effective operation" and "conformity with intended use."
II. In-Depth Analysis of New Key Requirements
1.Independent Article on Equipment Files (Article 41)
Specification of file content: Requires documents and records covering the entire process including procurement, installation, and validation.
Strengthened traceability: Provides complete documentation support for the whole lifecycle management of equipment.
2.New Requirement for Equipment/Instrument Re-confirmation (Article 40)
Clear trigger conditions: Re-confirmation is mandatory after modification or major repair.
Preemptive requirement: Must conform to requirements before use, reflecting the principle of risk prevention.
3.Refined Calibration Requirements (Article 69)
Range requirement: The calibrated range should cover the actual usage range.
Validity period management: Requires indicating the calibration or verification validity period to ensure the continuity of measurement traceability.
III. Comparative Analysis of Management Requirements
Management Dimension | 2014 Version Requirement | 2025 Revised Draft Requirement | Significance of Change |
Equipment Scope | Production equipment and process machinery | Production equipment, inspection instruments, tooling fixtures | Management scope expanded, covering more comprehensively |
File Management Requirement | Not explicitly required | Establish complete equipment files, including procurement traceability installation, validation records | Enhanced whole lifecycle |
Re-confirmation Requirement | Not explicitly required | Re-confirmation required after modification or major repair | Ensures ongoing compliance of equipment status |
Calibration Requirement | Periodic calibration, indicate validity period | Calibration range covers usage range, maintain complete records | More precise requirements |
Identification Management | Status labels to prevent unintended use | Added requirement for abnormal status labeling | More detailed risk management |
IV. Impact on Enterprises and Implementation Suggestions
Immediate Action Items:
1.Equipment File Review
Establish complete equipment files, including procurement records, installation reports, validation documents, etc.
Develop procedures for file updates and maintenance.
2.Establishment of Re-confirmation Procedures
Develop re-confirmation procedures following equipment modification and major repair.
Define standards and methods for re-confirmation.
3.Calibration System Optimization
Evaluate existing calibration plans to ensure the range covers the actual usage range.
Establish an early warning mechanism for calibration validity periods.
Medium to Long-Term Construction Focus:
1.Preventive Maintenance System
Develop preventive maintenance plans for key equipment.
Establish a mechanism for analyzing equipment performance trends.
2.Informatization Management
Consider introducing an Enterprise Asset Management (EAM) system.
Realize electronic management of equipment files, maintenance records, and calibration plans.
3.Personnel Capability Enhancement
Strengthen training for equipment operators and maintenance personnel.
Build a professional team for equipment management.
The revision of Chapter 5 reflects a significant upgrade in the philosophy of equipment management: from focusing on the mere presence of equipment to emphasizing its condition, from single-use management to whole lifecycle control, and from compliance requirements to performance optimization.
Enterprises need to establish a more systematic and refined equipment management system to ensure equipment remains in a controlled state continuously, providing reliable assurance for product quality. It is recommended that enterprises initiate the assessment and upgrade of their equipment 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 5 content between the old and new versions of the "Medical Device Production Quality Management Guīfàn".
Medical Device Production Quality Management Guīfàn (Revised Draft for Comments) | Medical Device Production Quality Management Guīfàn (2014 No. 64)
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Chapter 5: Equipment | Chapter 4: Equipment |
Article 35 [General Requirements] Enterprises shall be equipped with production equipment, inspection instruments and equipment, and tooling & fixtures, etc., suitable for the products produced and the scale, and ensure effective operation. Equipment and instruments shall be designed, selected, installed, maintained, and repaired to conform to the intended use, facilitating operation, cleaning, and maintenance.
| Article 19 Enterprises shall be equipped with production equipment and process equipment, etc., suitable for the products produced and the scale, and ensure effective operation. Article 20 The design, selection, installation, repair, and maintenance of production equipment must conform to the intended use, facilitating operation, cleaning, and maintenance. Production equipment shall have clear status identification to prevent unintended use. Enterprises shall establish operating procedures for the use, cleaning, maintenance, and repair of production equipment and maintain corresponding operation records. |
Article 36 [Equipment Files] Enterprises shall establish equipment and instrument files, including but not limited to documents and records related to the procurement, installation, and validation of the equipment and instruments. | |
Article 37 [Operating Procedures and Records] Enterprises shall establish operating procedures for the use, maintenance, and repair of major equipment and instruments and maintain relevant records to ensure the traceability of related activities. | Article 21 Enterprises shall be equipped with inspection instruments and equipment suitable for product inspection requirements. Major inspection instruments and equipment shall have clear operating procedures. Article 22 Enterprises shall establish usage records for inspection instruments and equipment; the record content includes usage, calibration, maintenance, and repair status, etc. |
Article 38 [Equipment Identification] Major equipment and instruments of the enterprise shall be marked with identification numbers and names. When abnormal conditions occur, abnormal status identification shall be provided to prevent unintended use. | |
Article 39 [Calibration and Verification] Enterprises shall regularly calibrate and verify major equipment and instruments according to operating procedures and calibration or verification plans; the calibrated range shall cover the actual usage range. Enterprises shall be equipped with appropriate measuring instruments. The range and accuracy of the measuring instruments shall meet the usage requirements and indicate the calibration or verification validity period. Corresponding records of calibration and verification shall be maintained. | Article 23 Enterprises shall be equipped with appropriate measuring instruments. The range and accuracy of the measuring instruments shall meet the usage requirements, indicate their calibration validity period, and maintain corresponding records. |
Article 40 [Equipment and Instrument Re-confirmation] Enterprises shall perform re-confirmation on equipment and instruments that have undergone modification or major repair; they can only be used after conforming to requirements. |
