Analysis of Medical Device Production Quality Management Practice(Part 10)-Industry dynamics-Anji Wande Medical Products Co., Ltd.

Analysis of Medical Device Production Quality Management Practice(Part 10)

Release time：2025-10-31

Chapter 10 "Production Management" of the new regulation demonstrates a significant shift from single-link control to whole-process systematic management. This revision expands from the original 13 articles to 17, not only improving existing requirements but also introducing several innovative management concepts.

The most notable change in the new regulation is the construction of a more systematic production control system. The introduction of material balance management requirements marks a shift in production process control from traditional result-oriented approaches to refined process management. Enterprises need to establish a balance monitoring mechanism for key materials, achieving real-time control of the production process by setting reasonable limits. This requirement not only helps prevent material mix-ups and cross-contamination but also provides a basis for process optimization through data trend analysis.

The clarification of the clearance management system further reflects the deepening of the preventive quality control philosophy. The new regulation requires enterprises to establish comprehensive clearance procedures covering material cleaning, document management, and environmental confirmation, and to incorporate clearance records into the batch production record system. This system design ensures effective isolation between production stages, eliminating the risk of material mixing and cross-contamination at the source.

The systematic establishment of a deviation handling procedure is another highlight of this revision. The new regulation requires enterprises to build a deviation management system covering the entire production and inspection process, including deviation identification, reporting, investigation, handling, and prevention. This requirement pushes enterprises from passive deviation handling to active risk prevention, achieving continuous improvement of the quality system through systematic root cause analysis and corrective/preventive actions.

The clarification of Unique Device Identification (UDI) requirements reflects the regulatory authorities' emphasis on the entire product lifecycle. Enterprises need to establish a complete management system from identifier creation, code application, to data upload. This requirement not only meets regulatory compliance needs but also provides enterprises with robust product traceability means.

Regarding production environment control, the new regulation achieves an upgrade from monitoring to control. Enterprises need to establish a complete environmental control system including monitoring, analysis, and intervention based on product characteristics and process requirements. This shift requires enterprises not only to collect environmental data but also to establish data analysis and trend judgment mechanisms to achieve active regulation of environmental parameters.

The expansion of product protection requirements is also noteworthy. The newly added cybersecurity protection requirement reflects the regulatory authorities' forward-looking consideration of quality risks for intelligent medical devices. Enterprises need to establish a multi-layered protection system covering physical security, data security, and network security to ensure product safety and reliability throughout its entire lifecycle.

Facing the new regulation requirements, enterprises should adopt a phased and systematic implementation strategy. First, a comprehensive gap analysis needs to be conducted, focusing on assessing the compliance of the existing management system in areas such as material balance, clearance management, deviation handling, and UDI implementation. Based on this, a detailed system upgrade plan should be developed, specifying timelines and responsible persons for each task.

Regarding system construction, it is recommended that enterprises prioritize the establishment of the UDI system and the deviation management system. The implementation of the UDI system requires coordinated advancement of hardware investment, software development, and process optimization, while the effective operation of the deviation management system relies on a sound quality culture and scientific analysis methods. The establishment of these systems can not only meet regulatory requirements but also bring substantial improvement to the enterprise's quality management level.

Attached at the end is a comparison of Chapter 10 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 10: Production Management	Chapter 8: Production Management
Article 76 [General Requirements] Enterprises shall establish production process control procedures, specifying requirements for operators, production equipment, raw materials and intermediate products, production processes and operating procedures, production environment, in-process inspection or monitoring, etc., and organize production according to the requirements.	Article 45 Enterprises shall conduct production in accordance with the established quality management system to ensure products comply with mandatory standards and registered or filed product technical requirements. Article 46 Enterprises shall prepare production process procedures, work instructions, etc., specifying key processes and special processes.
Article 77 [Raw Material Management] Enterprises shall effectively control raw materials, packaging materials, intermediate products, etc., during the production process. If cleaning is required, the enterprise shall define the cleaning method and requirements, and verify the cleaning effectiveness.	Article 47 If raw materials or intermediate products require cleaning during the production process, the cleaning method and requirements shall be defined, and the cleaning effectiveness shall be verified.
Article 78 [Environmental Monitoring and Control] Enterprises shall monitor and control the environment according to the characteristics of the production process and maintain records.	Article 48 Enterprises shall monitor the environment according to the characteristics of the production process and maintain records.
Article 79 [Batch Production Record] Each batch (unit) of product shall have production records meeting traceability requirements. Production records shall include at least the product name, specification/model, raw material batch number, production batch number or product serial number, production date, quantity, main equipment, process parameters, operators, etc., and reflect material balance or record material usage.	Article 50 Each batch (unit) of product shall have production records meeting traceability requirements. Production records include the product name, specification/model, raw material batch number, production batch number or product serial number, production date, quantity, main equipment, process parameters, operators, etc.
Article 80 [Material Balance] Enterprises shall check the yield and material balance of key materials according to product characteristics, ensuring the material balance meets the set limit requirements. If discrepancies occur, the enterprise shall investigate the cause and may only process the product as normal after confirming no potential risk.
Article 81 [Identification Control] Enterprises shall establish a product identification control procedure, using appropriate methods to identify products to prevent mix-ups, errors, and non-conforming intermediate products from flowing into the next process.	Article 51 Enterprises shall establish a product identification control procedure, using appropriate methods to identify products for easy identification and to prevent misuse and incorrect use. Article 52 Enterprises shall identify the inspection status of products during the production process to prevent non-conforming intermediate products from flowing into the next process.
Article 82 [Product Protection] Enterprises shall establish a product protection procedure specifying protection requirements for the product and its components, including contamination protection, electrostatic protection, network security protection, dust protection, corrosion protection, and transport protection, etc. Protection measures shall include identification, handling, packaging, storage, and safeguarding.	Article 54 Product instructions and labels shall comply with relevant laws, regulations, and standard requirements.
Article 83 [Product Protection] Enterprises shall establish a product protection procedure specifying protection requirements for the product and its components, including contamination protection, electrostatic protection, network security protection, dust protection, corrosion protection, and transport protection, etc. Protection measures shall include identification, handling, packaging, storage, and safeguarding.	Article 55 Enterprises shall establish a product protection procedure specifying protection requirements for the product and its components, including contamination protection, electrostatic protection, dust protection, corrosion protection, and transport protection requirements. Protection shall include identification, handling, packaging, storage, and safeguarding.
Article 84 [Clearance Management] Enterprises shall establish a clearance management system based on product characteristics and production reality to prevent contamination and mix-ups of materials and products involved in production, and misuse of related documents. Before starting the next production run, the enterprise shall confirm the clearance status of the previous run. Clearance records and confirmation shall be included in the batch production record.
Article 85 [Deviation Management] Enterprises shall establish a deviation handling procedure based on product production process characteristics, specifying deviation identification, reporting, recording, evaluation, investigation, handling, and corrective/preventive actions taken, and maintain corresponding records. Deviation handling shall cover the entire medical device production and inspection process.
Article 86 [Nonconforming Product Control] Enterprises shall establish a nonconforming product control procedure for the timely and effective identification, recording, isolation, and review of nonconforming materials, intermediate products, and finished products during production. If rework, downgrading, etc., are involved, the enterprise shall comply with relevant regulations and customer requirements.	Article 67 Enterprises shall establish a nonconforming product control procedure, defining the responsibilities and authorities of the departments and personnel controlling nonconforming products. Article 68 Enterprises shall identify, record, isolate, and review nonconforming products, and take corresponding disposal measures based on the review results.
Article 87 [Rework Management] If nonconforming products are reworked, the enterprise shall establish a rework control procedure, including operating instructions, re-inspection, and re-verification. The risks associated with rework shall be fully assessed.	Article 70 If nonconforming products can be reworked, the enterprise shall prepare rework control documents. Rework control documents include work instructions, re-inspection, and re-verification. If rework is not possible, relevant disposal procedures shall be established.
Article 88 [Product Traceability] Enterprises shall establish a product traceability procedure, specifying the scope, extent, identification, and necessary records for product traceability, including material numbers, batch or serial number management, and Unique Device Identification (if applicable).	Article 53 Enterprises shall establish a product traceability procedure, specifying the scope, extent, identification, and necessary records for product traceability.
Article 89 [Unique Device Identification] Enterprises shall establish requirements for the creation, coding, and data carrier of the Unique Device Identification according to the product type. The UDI database shall complete data upload according to relevant regulatory requirements.
Article 90 [Shared Production] For shared production workshops, production lines, or production equipment, enterprises shall establish corresponding management systems based on the principle of product quality risk control management to prevent potential risks such as material or product mix-ups, cross-contamination, and misuse of process parameters.
Article 91 [Continuous Production] For continuous production, enterprises shall define the maximum batch quantity or the longest production time and verify the impact of continuous production on the environment and equipment, etc. After reaching the maximum batch quantity or the longest production time, corresponding cleaning and maintenance shall be performed.
Article 92 [Production Resumption] For resuming production after a shutdown, enterprises shall formulate corresponding procedures specifying the assessment requirements for the production environment, production equipment, suppliers, raw materials, intermediate products, process water, and air conditioning systems, etc., and perform verification or validation when necessary.

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