18069717650
0572-5528222 0572-5528378
18069717650
0572-5528222 0572-5528378
Release time：2025-11-01
The new regulation exhibits clear systematic characteristics in its general quality control requirements. Building upon the original quality control procedures, it further specifies detailed requirements for the quality management organizational structure, inspection personnel, inspection operating procedures, sampling, inspection equipment, and product release. This change compels enterprises to establish a more comprehensive quality control system, ensuring effective control over every step from materials to finished products. The specification of qualification requirements for inspection personnel is a highlight of this revision, clearly stipulating that their educational background, technical capability, and numbers must match the inspection tasks, and they must undergo practical training and assessment before assuming their posts. This requirement will effectively enhance the professionalism of the inspection team.
Regarding the formulation of inspection procedures, new requirements based on risk management principles have been introduced. Enterprises need to develop comprehensive inspection procedures covering incoming inspection, in-process inspection, and finished product inspection, based on regulations and product technical requirements. It is particularly noteworthy that the new regulation requires inspection procedures to cover all performance indicators specified in the registered or filed product technical requirements. If coverage is not possible, an explanation must be provided along with a validated alternative solution. The requirements for establishing test methods are further clarified; test methods should be suitable for the corresponding product performance indicators and should be verified or validated when necessary. Concurrently, specific management requirements for testing aids such as reference standards, microbial strains, culture media, and others are introduced, reflecting a new approach to comprehensive control of the testing process.
The newly added sample management requirements mark a step towards refinement in quality control. Enterprises should establish and maintain sound sample management procedures, clearly defining requirements for sampling methods, sample size, identification, and storage conditions to ensure samples remain controlled throughout the entire inspection process. Requirements for inspection record management have also become stricter. Article 98, while retaining the original traceability requirement, further details the specific content of inspection records, requiring complete information including product information, test items, inspection equipment, test results, etc. These requirements will help achieve end-to-end traceability of the inspection process.
The requirements for inspection equipment management show a greater focus on practical effectiveness. In addition to the original calibration and verification requirements, the new regulation adds a requirement for confirming calibration results and emphasizes that when equipment is found not to meet requirements, previous inspection results must be evaluated. This change reflects a shift in management philosophy from formal compliance to substantive effectiveness. Requirements for inspection environment control are also further strengthened, requiring enterprises to define, monitor, and control the inspection environment based on product testing needs, and to stipulate environmental conditions meeting specific professional requirements for specialized testing laboratories.
The stricter product release requirements are one of the core changes in this revision. The new regulation specifies six detailed conditions for product release, covering multiple dimensions such as completion of all specified process flows, completeness of batch production records, and completeness of quality control records. These clear standards provide specific basis for enterprises to establish standardized release procedures. Regarding entrusted testing management, while maintaining the basic principle that routine test items generally cannot be outsourced, the new regulation imposes stricter management requirements for items that genuinely require outsourcing. Enterprises need to sign quality agreements and evaluate the testing capabilities of the entrusted testing organization to ensure the accuracy and reliability of the entrusted test results.
The revision of the Quality Control chapter reflects an important shift in medical device regulation from focusing on test results to paying attention to the entire process of quality control. By constructing a more systematic and stringent quality control system, it will effectively enhance the quality level of medical device products and lay a solid foundation for high-quality development in the industry. Enterprises should seize this opportunity and focus on promoting the following tasks: systematically review the existing quality control system and improve inspection procedures and operational documents against the new regulation requirements; strengthen the construction of the inspection personnel team and enhance inspection capabilities through systematic training and strict assessment; improve the inspection equipment management and environmental control system to ensure the conformity of testing conditions; establish and improve the product release review mechanism to strictly guard the final quality gate. Through these measures, enterprises will be better able to adapt to the new regulation requirements, enhance market competitiveness, and provide higher quality medical device products for patients.
Attached at the end is a comparison of Chapter 11 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 11: Quality Control and Product Release | Chapter 9: Quality Control |
Article 93 [General Quality Control Requirements] Enterprises shall establish quality control procedures, specifying requirements for the product quality management organizational structure, inspection personnel, inspection operating procedures and sampling, inspection equipment, product release, and retention samples, etc., to ensure that necessary inspections are completed and quality conforms to requirements before the release of materials or products. | Article 56 Enterprises shall establish quality control procedures, specifying requirements for the product inspection department, personnel, operations, etc., and shall specify requirements for the use and calibration of inspection instruments and equipment, as well as the procedures for product release. |
Article 94 [Inspection Personnel] The educational background, technical capability, and number of inspection personnel shall match the product inspection and testing work, and they shall undergo practical training and assessment related to the inspection and testing operations they perform before assuming their posts. | |
Article 95 [Inspection Operating Procedures] Enterprises shall formulate documents such as incoming inspection procedures, in-process inspection procedures, and finished product inspection procedures based on regulations, product technical requirements, risk management principles, and product quality assurance capabilities, etc. The inspection procedures shall cover the performance indicators specified in the registered or filed product technical requirements; if coverage is not possible, an explanation shall be provided, and a validated alternative solution shall be given when necessary. | Article 58 Enterprises shall formulate product inspection procedures according to mandatory standards and the registered or filed product technical requirements, and issue corresponding inspection reports or certificates. Routine incoming inspection, in-process inspection, and finished product inspection items shall, in principle, not be entrusted for testing. For items with high testing condition and equipment requirements that genuinely require entrustment, testing may be entrusted to a qualified organization to prove the product conforms to mandatory standards and the registered or filed product technical requirements. |
Article 96 [Test Methods] The establishment of test methods shall be suitable for the performance indicators of the corresponding product, and verification or validation shall be carried out when necessary. Management documents shall be established for reference standards (reference materials), microbial strains, culture media, and other auxiliary supplies required for conducting inspection work, based on their control characteristics, to ensure they meet inspection requirements. | |
Article 97 [Inspection Sample Management] Enterprises shall establish an inspection sample management process, defining requirements for sampling methods, sample size, identification, storage conditions, etc., according to product characteristics, to ensure samples are controlled during sampling, distribution, receipt, storage, return, or disposal. | |
Article 98 [Inspection Activities and Records] Enterprises shall carry out inspection and testing activities in accordance with the inspection procedures. Each batch (unit) of product shall have inspection records meeting traceability requirements, the content including at least product or material information, test items, inspection equipment, test results, inspection date, inspection personnel, reviewing personnel, etc. | Article 59 Each batch (unit) of product shall have inspection records meeting traceability requirements. Inspection records shall include records for incoming inspection, in-process inspection, and finished product inspection, inspection reports, or certificates, etc. |
Article 99 [Inspection Equipment] The management and use of inspection equipment shall comply with the following requirements: (1) Regularly calibrate or verify inspection equipment and confirm the results; (2) Specify protection requirements for inspection equipment during handling, maintenance, and storage to prevent inaccurate inspection results; (3) When inspection equipment is found not to meet requirements, previous inspection results shall be evaluated, and appropriate measures taken when necessary.
| Article 57 The management and use of inspection equipment shall comply with the following requirements: (1) Regularly calibrate or verify inspection equipment and label them accordingly; (2) Specify protection requirements for inspection equipment during handling, maintenance, and storage to prevent inaccurate inspection results; (3) When inspection equipment is found not to meet requirements, previous inspection results shall be evaluated, and verification records shall be maintained; (4) Computer software used for inspection shall be validated. |
Article 100 [Environmental Monitoring and Control] Enterprises shall define, monitor, and control the inspection environment according to product inspection requirements, and maintain corresponding records. Laboratories conducting special professional inspections shall have environmental facility conditions conforming to their specific professional requirements. | |
Article 101 [Nonconformity Handling] Enterprises shall establish procedures for the investigation and handling of nonconforming inspection results according to product characteristics. Any nonconforming inspection or test result must be investigated and handled according to the procedure, and records retained. For nonconformities caused by deviations in the inspection process, re-inspection may be performed. | |
Article 102 [Release Requirements] Enterprises shall establish a product release procedure, clarifying product release conditions, review, and approval requirements, etc. Before product release, at least the following conditions shall be met: (1) All specified process flows are completed; (2) The specified batch production records are complete; (3) All specified quality control records are complete, results conform to specified requirements, and records have been signed off as specified; (4) The entire product realization process has been completed as specified; (5) The product instructions, labels, and their versions conform to specified requirements; (6) The authorized release personnel have signed the product release document as specified. | Article 60 Enterprises shall define product release procedures, conditions, and release approval requirements. Released products shall be accompanied by a certificate of conformity. |
Article 103 [Product Retention Samples] Enterprises shall establish retention sample management procedures according to product and process characteristics, conduct retention sampling as specified, and maintain retention sample observation records. | Article 61 Enterprises shall establish retention sample management regulations according to product and process characteristics, conduct retention sampling as specified, and maintain retention sample observation records. |
Article 104 [Entrusted Testing] Routine incoming inspection, in-process inspection, and finished product inspection items shall not be entrusted for testing. For items with high testing condition and equipment requirements that genuinely require entrustment, testing may be entrusted to a qualified organization. For entrusted testing, the enterprise shall sign a quality agreement, clearly defining the responsibilities of both parties and the entrusted testing requirements. The entrusting party shall evaluate the testing capabilities of the entrusted testing organization to ensure the entrusted test results are accurate and reliable. |
