Analysis of Medical Device Production Quality Management Practice(Part 15)-Industry dynamics-Anji Wande Medical Products Co., Ltd.

Analysis of Medical Device Production Quality Management Practice(Part 15)

Release time：2025-11-22

Chapter 15, "Supplementary Provisions," has been significantly expanded and refined compared to the original version. Notably, the number of defined terms has increased from none to a comprehensive set of 35. This major change provides a clearer and more unified terminological foundation for the implementation of the entire Guifan.

I.Clarification and Improvement of Guifan Applicability

The new Article 128, while building upon the original requirements, further clarifies the positioning of this Guifan as the fundamental requirement for medical device production. It also states that specific requirements for different categories of medical devices should refer to the detailed provisions issued by the National Medical Products Administration (NMPA). This formulation maintains the universality of the Guifan while allowing flexibility for the management of various specialized medical devices, reflecting a management approach that combines principle with flexibility.

The provision allowing enterprises to determine clauses not applicable based on the characteristics of the medical devices they produce is retained, but it requires justification for such non-applicability. This mechanism respects the diverse nature of medical devices while requiring enterprises to provide sufficient technical justification and quality risk assessment for any exempted clauses, preventing quality risks that might arise from arbitrarily excluding Guifan requirements.

II. Systematic Construction of the Terminology System

The most significant change in the new regulation is the establishment of a complete terminology definition system. The definitions of the 35 terms not only cover basic quality management concepts but also include specific definitions tailored to the characteristics of the medical device industry. These definitions demonstrate clear systematic structure and hierarchy, providing a solid foundation for understanding and implementing the Guifan.

Regarding basic concepts, the new Guifan provides clear definitions for fundamental terms such as "Finished Product," "Intermediate Product," and "Nonconforming Product," establishing a clear product status classification system. Particularly, the definition of "Product Characteristics" explicitly includes aspects like intended use, function, performance, structural composition, and validity period, offering clear guidance for enterprises to comprehensively understand product quality requirements.

III. Deepening of Core Quality Management Concepts

The new Guifan provides more precise definitions for key roles and core concepts within the quality management system. The definition of "Management Representative" clarifies their core position and specific responsibilities within the quality management system, emphasizing their key role in its establishment, implementation, maintenance, and improvement. The expanded concept of "Materials" reflects comprehensive control over production inputs, explicitly incorporating new production factors like information systems into the management scope.

In terms of process management, the new Guifan provides clear distinctions between the important concepts of "Verification" and "Validation." "Verification" emphasizes meeting specified requirements, while "Validation" focuses on fulfilling specific intended uses. This distinction helps enterprises carry out related activities more precisely. The clear definitions of "Critical Process" and "Special Process" provide clear standards for enterprises to identify and control key quality links.

IV. Definition of Emerging Business Models

Addressing trends in the medical device industry, the new Guifan clearly defines emerging business models such as entrusted production and outsourced processing. "Entrusted Production" is defined as the scenario where a medical device registrant or filing person entrusts all processes of the finished medical device to an enterprise with corresponding conditions. "Outsourced Processing" refers to entrusting part of the processes to another enterprise for production. This distinction clarifies the management requirements for different entrustment models, providing institutional assurance for the standardized development of the industry.

It is particularly noteworthy that the new Guifan clarifies the conceptual differences between "Production Release," "Market Release," and "Product Release," establishing a comprehensive release management system. This distinction not only clarifies the responsibilities of various parties in entrusted production but also provides clear guidance for release activities for different types of enterprises.

V. Terminology Support for Digital Management

To adapt to the trend of digital transformation in the medical device industry, the new Guifan adds definitions for terms related to digital management, such as "Electronic Record," "Information System," and "Data." The clarification of these terms provides an institutional foundation for enterprises to advance quality management digitalization and also offers a basis for regulatory authorities to conduct digital supervision.

The definition of "Electronic Record" emphasizes its digital format characteristics and dependence on information systems. The concept of "Data" covers various forms such as text, numerical values, symbols, images, and audio. These definitions reflect a proactive response to quality management requirements in the new context.

VI. Implementation Key Points and Transition Arrangements

According to the new Article 131, the Guifan will officially take effect in 2025, simultaneously repealing the original Guifan issued in 2014. This transition period provides enterprises with sufficient preparation time. It is recommended that enterprises prioritize the following tasks: First, organize company-wide study of the new Guifan's terminology system to ensure accurate and consistent understanding of key concepts. Second, revise internal quality management documents against the new term definitions to ensure normative use of terminology. Third, establish corresponding management procedures for newly introduced concepts such as "Production Release" and "Market Release." Finally, conduct terminology communication with relevant parties in the supply chain to ensure consistency in understanding throughout the entire supply chain system.

During the transition period, enterprises should create a terminology comparison table to clarify the correspondence between old and new terms, preventing quality management loopholes caused by misunderstandings of terminology. Simultaneously, special attention should be paid to the management requirements corresponding to the newly added terms, promptly improving relevant management systems and processes.

A comparison of the content of Chapter 15 between the old and new versions of the "Medical Device Production Quality Management Guifan" is appended below.

Medical Device Production Quality Management Guifan (Revised Draft for Comments)	Medical Device Production Quality Management Guifan (2014 No. 64)
Chapter 15: Supplementary Provisions	Chapter 13: Supplementary Provisions
	Article 79 Medical device registration applicants or filing persons shall also comply with the relevant requirements of this Guifan during product development.
Article 128 This Guifan specifies the fundamental requirements for medical device production. Specific requirements for different categories of medical devices shall refer to the detailed provisions issued by the National Medical Products Administration. An enterprise may determine clauses of this Guifan that are not applicable based on the characteristics of the medical devices it produces, and shall justify the non-applicability.	Article 80 The former China Food and Drug Administration shall formulate detailed specific provisions for the special requirements of production for different categories of medical devices. Article 81 An enterprise may determine clauses of this Guifan that are not applicable based on the characteristics of the medical devices it produces, and shall justify the non-applicability.
Article 129 The meanings of the following terms used in this Guifan are:	Article 82 The meanings of the following terms used in this Guifan are:
1.Finished Product: A product that has completed all production processes and final packaging and bears a label.
2.Intermediate Product: A product that has completed part of the processing steps and requires further processing.
3.Nonconforming Product: Materials, intermediate products, bulk products, or finished products that do not conform to requirements.
4.Product Characteristics: The unique attributes and features possessed by a product during design, development, and production, including aspects such as the product's intended use function, performance, structural composition, and validity period.
5.Management Representative: A member of senior management appointed by the enterprise's responsible person, responsible for establishing, implementing, and maintaining the quality management system, reporting on the operation of the quality management system and improvement needs, and enhancing employees' awareness of meeting legal, regulatory, rule, and customer requirements.
6.Materials: All materials and tools used in product production, including raw materials, intermediates, auxiliary materials, instructions and labels, packaging materials, reagents, consumables, and information systems, etc.
7.Raw Materials: Components such as ingredients, purchased parts, and software that constitute the product.
8.Critical Materials: Materials that have a significant impact on critical processes or product quality.
9.Supplier: A provider of materials, equipment, instruments, reagents, software, services, etc., such as a manufacturer or distributor.
10.Quality Assurance: The totality of the organized and planned activities implemented within an enterprise's quality management system to ensure that products meet requirements.
11.Quality Risk Management: Activities to identify, assess, control, communicate, and review quality risks throughout the product lifecycle, using prospective or retrospective approaches.
12.Medical Device Production: Activities involving design, processing, manufacturing, assembly, etc., and the provision of the final medical device product. Suppliers performing production service activities such as sterilization, installation, surface coating, anodizing, etc., for medical device registrants, filing persons, or entrusted manufacturers shall comply with the relevant requirements of this Guifan.
13.Entrusted Production: The scenario where a medical device registrant or filing person entrusts all processes of the finished medical device to an enterprise with corresponding conditions for production.
14.Outsourced Processing: The scenario where a medical device manufacturer, due to limitations in production capacity, equipment, or technology, entrusts part of the production processes to another enterprise.
15.Outsourced Processor: The recipient party in outsourced processing.
16.Validation: The process of obtaining objective evidence that specific intended uses or application requirements have been fulfilled, e.g., a series of activities proving that premises, facilities, and equipment operate correctly and achieve expected results.	Validation: The process of obtaining objective evidence that specific intended uses or application requirements have been fulfilled.
17.Verification: The process of obtaining objective evidence that specified requirements have been fulfilled, e.g., a series of activities proving that any operational procedure or method, production process, or system can achieve expected results.	Verification: The process of obtaining objective evidence that specified requirements have been fulfilled.
18.Critical Process: A process that plays a decisive role in product quality.	Critical Process: A process that plays a decisive role in product quality.
19.Special Process: A process whose quality is difficult to accurately assess through inspection and testing.	Special Process: A process whose quality is difficult to accurately assess through inspection and testing.
20.Batch: A defined quantity of raw materials, packaging materials, or finished products produced in one or a series of processes, possessing intended uniform quality and characteristics. To perform certain production operations, it may be necessary to divide a batch into several sub-batches, which are later combined to form a uniform batch. In the case of continuous production, a batch must correspond to a defined quantity of product with intended uniform characteristics; the batch size can be a fixed quantity or the product quantity produced within a fixed time period.
21.Batch Number: Any unique combination of numbers and/or letters used to identify a specific batch.
22.Deviation: Any departure from approved procedures (instructional documents) or established standards, such as any departure from production processes, material balance limits, quality standards, testing methods, operating procedures, etc., all fall within the category of deviation.
23.Corrective Action: Action taken to eliminate the cause of a detected nonconformity. Preventive Action: Action taken to eliminate the cause of a potential nonconformity or other potential undesirable situation.
24.Management Review: The evaluation activity conducted by the enterprise's responsible person to ensure the continuing suitability, adequacy, and effectiveness of the quality management system.
25.Record: A document generated through the recording of one or more pieces of data during activities such as medical device design and development, production, sales, and after-sales service, which states the results achieved or provides evidence of the activities performed.
26.Electronic Record: A document/record in a digital format, composed of text, graphics, data, sound, diagrams, or other digital information. Its creation, modification, maintenance, archiving, retrieval, distribution, and use are all realized through an information system.
27.Information System: An integrated system used for reporting or automatic control, including data input, electronic processing, and information output.
28.Data: Information generated during activities such as medical device design and development, production, sales, and after-sales service that reflects the execution of activities, including: text, numerical values, symbols, images, audio, pictures, spectra, barcodes, etc.
29.Clean Area: An area (room) where the number of airborne particles and microorganisms in the environment needs to be controlled, and whose construction, equipment, and use should minimize the introduction, generation, and retention of contaminants within the area.
30.Contamination: The process where raw materials, primary packaging materials, intermediate products, bulk products, etc., are adversely affected by chemical, microbial, particulate, foreign matter, or other external factors during production, sampling, packaging, or storage and transportation.
31.Line Clearance: A series of activities performed to clean the work area and production equipment when changing production batches or products, to prevent mix-ups and errors between different varieties, specifications, or batches during medical device production, and to prevent confusion of materials, documents, records, etc.
32.Rework: The activity of returning a part or all of a nonconforming product before release to previous process steps for reprocessing, to make it conform to requirements.
33.Production Release: In entrusted production activities, the activity where the entrusted party, through reviewing the production process records and quality inspection records of a medical device production batch, confirms that all stipulated activities and arrangements have been completed according to the document requirements agreed upon by both parties, allowing the medical device to be delivered to the medical device registrant or filing person.
34.Market Release: In entrusted production activities, the activity where the registrant or filing person, through reviewing the production process records and quality inspection records of a medical device production batch, confirms that all stipulated activities and arrangements have been completed according to regulatory and system requirements and meet the release criteria, allowing the medical device to be released to the market.
35.Product Release: The activity where the registrant or filing person, through reviewing the production process records and quality inspection records of a medical device production batch, confirms that all stipulated activities and arrangements have been completed according to regulatory and system requirements and meet the release criteria, allowing the medical device to be delivered to the customer. The conformity certificate provided by some enterprises upon product release refers to the relevant documents or labels proving that the medical device has passed inspection before leaving the factory, which may include the medical device inspection report, certificate of conformity, etc.
Article 130 This Guifan shall be interpreted by the National Medical Products Administration.	Article 83 This Guifan shall be interpreted by the former China Food and Drug Administration.
Article 131 This Guifan shall take effect on X month X day, 2025. The "Medical Device Production Quality Management Guifan (2014 No. 64)" issued by the former China Food and Drug Administration on December 29, 2014, is simultaneously repealed.	Article 84 This Guifan shall take effect on March 1, 2015. The "Medical Device Production Quality Management Guifan (Trial)" (Former SFDA Device [2009] No. 833) issued by the former China Food and Drug Administration on December 16, 2009, is simultaneously repealed.

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