In-Depth Interpretation Series Of The Revised Draft 《Medical Device Production Quality Management Guīfàn》 (Part 3)
Sep 08, 2025
Qualification requirements comprehensively elevated, quality veto power and independence become regulatory core.The content of Chapter 3 of the new regulation has expanded from 7 articles in the original version to 11 articles, putting forward more specific and stringent requirements for enterprises' organizational structure, key personnel qualifications, and responsibilities, reflecting the regulatory emphasis on the "human" factor in quality management.
I. Optimized Chapter Structure, Highlighting the Independence of the Quality Management Department
Main Changes:
New independent article: Specifically establishes Article 14 [Quality Management Department], emphasizing that the quality management department must "independently perform quality assurance and quality control duties, and have the right of veto over product quality."
Clarified responsibilities: Clarifies that the quality department needs to "participate in all activities related to product quality, and be responsible for reviewing documents related to this Guīfàn."
Regulatory intent: To ensure the independence and authority of quality management, preventing the quality department from being unduly influenced by production, marketing, and other departments.
II. Comprehensive Detailing of Requirements for Key Position Personnel
The new regulation provides more specific requirements for the qualifications and responsibilities of key personnel, mainly reflected in the following aspects:
1.Significantly Elevated Requirements for the Management Representative
Educational requirements: Management Representatives for Class II and III medical device enterprises must have an undergraduate degree or higher in a medical device-related major; for Class I medical device enterprises, an associate degree or higher in a related major is required.
Experience requirements: Clearly requires more than 3 years of experience in medical device quality management or production and technical management.
Expanded responsibilities: Expanded from 4 responsibilities in the original version to 5 specific duties, adding content such as "ensuring products meet release requirements" and "cooperating with medical device regulatory authorities for supervision and inspection."
2.New Full-Time Requirement for the Person in Charge of Quality Management
Qualification requirements: Must have an undergraduate degree or higher in a medical device-related major or an intermediate professional technical title, along with more than three years of experience in medical device production or quality management.
Clarified responsibilities: Clearly lists seven specific duties, including product release review, deviation investigation, and post-market quality management.
3.Specified Requirements for the Person in Charge of Production Management
Educational requirements: Associate degree or higher.
Clarified responsibilities: Clearly defines five production management duties to ensure production process compliance.
4.New Qualification Requirements for Release Reviewers
Independence requirement: Clearly states that release reviewers should be personnel from the quality management department or other higher-level management personnel.
Capability requirement: Requires specialized training and the ability to independently undertake product release review responsibilities.
III. Strengthened Personnel Management and Training Requirements
Standardized training management: Requires enterprises to establish a training system, develop training plans, maintain training records, and evaluate training effectiveness.
Detailed health management: Manage employee health based on the characteristics of the produced products and establish sound health records.
Clear job responsibilities: Requires that job responsibilities must not be omitted, overlapping responsibilities must be clearly defined, and no individual should bear too many responsibilities.
IV. Impact on Enterprises and Implementation Suggestions
Immediate Action Items:
1.Organizational Structure Assessment and Adjustment
Ensure the independence and authority of the quality management department.
Clarify the responsibilities and authorities of each department to avoid overlap or omission.
2.Key Personnel Qualification Verification
Verify whether the education and experience of the Management Representative, Person in Charge of Quality, and Person in Charge of Production meet the new regulation requirements.
Develop recruitment or training plans for key position personnel.
3.Document System Update
Update job responsibility descriptions.
Revise training management systems and health management plans.
Medium to Long-Term Construction Focus:
1.Talent Pipeline Construction
Establish a talent reserve mechanism for key positions.
Develop continuous professional development plans.
2.Quality Culture Cultivation
Strengthen company-wide quality awareness training.
Establish a mechanism linking quality performance to personal development.
3.Management System Optimization
Establish a comprehensive job qualification system.
Optimize the training effectiveness evaluation mechanism.
The requirements for key personnel in the new regulation align with those of the EU MDR/IVDR and the US FDA, which is beneficial for enterprises to establish a quality management system that meets global market requirements and reduces compliance costs. The revision of Chapter 3 reflects an important shift in regulatory thinking: from simply "setting up positions" to emphasizing "personnel capability," and from "formal compliance" to "substantive effectiveness." Enterprises need to re-examine their organizational structure and personnel allocation to ensure that key personnel are not only "in position" but also "effective." It is recommended that enterprises initiate human resources assessment and planning as soon as possible to ensure the optimization of the organizational structure and the improvement of personnel capabilities during the transition period, laying the foundation for sustainable development under the new regulatory environment.
Attached at the end is a comparison of Chapter 3 content between the old and new versions of the "Medical Device Production Quality Management Guīfàn".
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Medical Device Production Quality Management Guīfàn (Revised Draft for Comments) |
Medical Device Production Quality Management Guīfàn (2014 No. 64) |
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Chapter 3: Organization and Personnel |
Chapter 3: Organization and Personnel |
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Article 13 [General Requirements] Enterprises shall establish an organizational structure suitable for medical device production, define the responsibilities and authorities of each department, and clarify quality management functions. The persons in charge of the production management department and the quality management department shall not hold concurrent positions. |
Article 5 Enterprises shall establish a management structure suitable for medical device production, ~~and have an organizational chart~~, define the responsibilities and authorities of each department, and clarify quality management functions. The persons in charge of the production management department and the quality management department shall not hold concurrent positions. |
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Article 14 [Quality Management Department] Enterprises shall establish a quality management department suitable for product production requirements, participate in all activities related to product quality, and be responsible for reviewing documents related to this Guīfàn The quality management department shall independently perform quality assurance and quality control duties and have the right of veto over product quality |
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Article 15 [Staffing and Job Responsibilities] Enterprises shall be equipped with a sufficient number of professional technical personnel, management personnel, production operators, and full-time inspection personnel with corresponding qualifications (including education, training, and practical experience)**. The responsibilities of each position shall be clearly defined; position responsibilities shall not be omitted, and overlapping responsibilities shall be clearly defined. The number of responsibilities borne by each person should not be excessive. |
Article 9 Enterprises shall be equipped with professional technical personnel, management personnel, and operators suitable for the products being produced, and have a corresponding quality inspection agency or full-time inspection personnel. |
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Article 16 [Key Personnel] Enterprises shall be equipped with key personnel suitable for the products being produced. Key personnel shall be full-time personnel of the enterprise and shall at least include the enterprise responsible person, management representative, production management responsible person, quality management responsible person, and product release reviewer, etc. Key personnel shall be familiar with relevant medical device laws and regulations, have practical experience in quality management, and have the ability to make correct judgments and handle practical problems in production management and quality management. |
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Article 17 [Enterprise Responsible Person] The enterprise responsible person is the main person responsible for the quality and safety of medical device products and shall perform the following duties: 1.Organize the formulation of the enterprise's quality policy and quality objectives; 2.Ensure the human resources, infrastructure, and working environment required for the effective operation of the quality management system; 3.Organize the implementation of manageme- nt reviews, regularly evaluate the operation of the quality management system, and pursue continuous improvement; 4. Ensure that the Management Representative, the Person in Charge of Quality Management, and the Product Release Reviewer perform their duties independently, free from interference from internal factors within the enterprise; 5. Organize production in accordance with relevant laws, regulations, rules, mandatory standards, and product technical requirements. |
Article 6 The enterprise responsible person is the main person responsible for the quality of medical device products and shall perform the following duties: 1.Organize the formulation of the enterprise's quality policy and quality objectives; 2.Ensure the human resources, infrastructure, and working environment required for the effective operation of the quality management system; 3.Organize the implementation of manageme- nt reviews, regularly evaluate the operation of the quality management system, and pursue continuous improvement; 4. Organize production in accordance with the requirements of laws, regulations, and rules. |
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Article 18 [Management Representative] The enterprise responsible person shall appoint a Management Representative from among the senior management personnel of the enterprise. The Management Representative of a Class II or III medical device manufacturing enterprise shall have an undergraduate degree or higher in a medical device-related major; the Management Representative of a Class I medical device manufacturing enterprise shall have an associate degree or higher in a medical device-related major. In principle, the Management Representative should have three years or more of experience in medical device quality management or production and technology management (or an intermediate or higher technical title), be familiar with product production and quality management, and have good performance ability. The Management Representative shall perform duties including but not limited to the following: 1.Organize the implementation of relevant laws, regulations, rules, mandatory standards, and registered or filed product technical requirements; 2.Establish a quality management system suitable for the products being produced and maintain its effective operation; 3.Ensure that products meet release requirements, and organize the collection of information on post-market product quality; 4. Organize self-inspections of the quality management system, adverse event monitoring and reporting, medical device recalls, etc. Regularly report the operation of the quality management system and improvement needs to the enterprise responsible person; 5. Cooperate with the drug supervision and administration department in carrying out supervision and inspection. For identified problems, organize relevant departments of the enterprise to make timely corrections as required. |
Article 7 The enterprise responsible person shall designate a Management Representative. The Management Representative is responsible for establishing, implementing, and maintaining the quality management system, reporting the operation of the quality management system and improvement needs, and enhancing employees' awareness of meeting regulatory, rule, and customer requirements. |
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Article 19 [Person in Charge of Quality Management] The Person in Charge of Quality Management shall have an undergraduate degree or higher in a medical device-related major or an intermediate professional technical title, and simultaneously possess more than three years of experience in medical device production or quality management. The Person in Charge of Quality Management shall perform at least the following duties: 1.Ensure that the production and inspection of materials and products comply with relevant laws, regulations, rules, mandatory standards, and registered or filed product technical requirements; 2. Organize product release review; 3.Ensure that all major deviations and non-conformities in the production process have been investigated and dealt with promptly; 4.Organize post-market product quality management activities, ensuring that all returns, complaints, and adverse events related to product quality have been investigated and handled promptly and correctly; 5.Ensure the completion of the annual product quality review analysis; 6.Ensure that personnel in this department have received relevant training and mastered relevant regulations, theoretical knowledge, and practical operation skills; 7.Be responsible for other activities related to product quality. |
Article 8 The persons in charge of the technology, production, and quality management departments shall be familiar with relevant medical device laws and regulations, have practical experience in quality management, and have the ability to make correct judgments and handle practical problems in production management and quality management. |
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Article 20 [Person in Charge of Production Management] The Person in Charge of Production Management shall have an associate degree or higher in a medical device-related major and possess more than three years of experience in medical device production or quality management. The Person in Charge of Production Management shall perform duties including but not limited to the following: 1.Ensure that product production is organized according to process procedures, work instructions, etc.; 2.Ensure that production records are authentic, accurate, complete, timely, and traceable; 3.Organize the maintenance of plant facilities and equipment to ensure they remain in good operating condition; 4.Ensure that employees in this department are trained and possess knowledge and practical operation skills suitable for their job requirements; 5.Be responsible for other activities related to product production. |
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Article 21 [Release Reviewer] The Release Reviewer shall be personnel from the quality management department or other higher-level management personnel, shall have received training related to product release, possess the ability to review product releases, and be able to independently undertake the responsibility of product release review. |
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Article 22 [Training Management] Enterprises shall designate a department or a person responsible for training management, establish a training system, develop training plans, and maintain training records. All personnel engaged in work affecting product quality shall receive training suitable for their job requirements in regulations, job responsibilities, and practical operation skills, to ensure that the relevant personnel clearly understand their responsibilities, are familiar with the requirements related to their responsibilities, and possess relevant theoretical knowledge and practical operation skills. The actual effectiveness of training shall be evaluated |
Article 10 Personnel engaged in work affecting product quality shall receive training suitable for their job requirements and possess relevant theoretical knowledge and practical operation skills. |
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Article 23 [Health Management] For personnel engaged in work affecting product quality, enterprises shall manage their health according to the characteristics of the products being produced and establish sound health records. |
Article 11 For personnel engaged in work affecting product quality, enterprises shall manage their health and establish sound health records. |
