To the Drug Administration of all provinces, autonomous regions, municipalities directly under the Central Government and the Xinjiang Production and Construction Corps, and all relevant units:
Classification management is an important foundational system for medical device supervision. In recent years, the reform of medical device classification management in China has been continuously promoted, the management system and operating mechanism have been continuously improved, the classification rules and catalog have been revised in a timely manner, and regulatory efficiency and industrial development have been effectively improved. With the rapid development of medical device related technology and industry, the supervision of medical devices is facing new situations, new tasks, and new requirements. The workflow of classification management needs to be further optimized, the supporting capacity needs to be further improved, and the implementation of classification management system needs to be further strict. In order to implement the Implementation Opinions of the General Office of the State Council on Comprehensively Strengthening the Construction of Drug Regulatory Capacity (Guo Ban Fa [2021] No. 16) and implement the relevant requirements for deepening the reform of the medical device evaluation and approval system, the following opinions are proposed to further strengthen and improve the classification management of medical devices:
1、 Overall requirements
Guided by the thought of Socialism with Chinese characteristics for a new era, implement the Regulations on the Supervision and Administration of Medical Devices, implement the "four strictest" requirements, base on China's reality, learn from international experience, optimize the management system, improve the management system, strengthen the support ability, improve quality efficiency, further improve the scientific, legal, international and modern level of medical device classification management, and help promote high-quality industrial development, Better protection and promotion of public health.
2、 Key Tasks
（1） Optimize the classification management organizational system
1. Clarify the job responsibilities of all parties. The National Medical Products Administration is responsible for formulating classification rules and catalogs for medical devices. Based on the production, operation, and use of medical devices, it timely analyzes and evaluates the risk changes of medical devices, dynamically adjusts the classification rules and catalogs, and supervises their implementation. The provincial drug supervision and management department is responsible for supervising the implementation of the medical device classification management system. The Medical Device Classification Technical Committee, under the leadership of the National Drug Administration, conducts research on medical device classification and related technologies, providing technical support for medical device classification management.
2. Strengthen the management of the Classification Technical Committee. Clarify the responsibilities and requirements of the Executive Committee, Professional Group, and Secretariat of the Medical Device Classification Technical Committee, improve the operational mechanism, strengthen the management of committee members, improve the assessment and evaluation mechanism of committee members and professional groups, explore the establishment of incentive and constraint mechanisms, continuously increase the training of committee members, strengthen the technical support role of the Classification Technical Committee, and promote the effective service and supervision of classification management.
（2） Improve the classification management system
3. Refine the classification principles and requirements. Improve the classification management system consisting of classification rules, guiding principles for classification definition, and classification catalogs. Research and revise the "Classification Rules for Medical Devices" to lay the foundation for orderly adjustment of product categories. Focusing on regulatory hotspots, common issues, and urgent issues in areas such as new materials and high-tech, we will study and refine the guiding principles for classification and definition within the framework of classification rules, unify the principles and scales for product classification and definition in relevant fields, and serve the high-quality development of the industry.
4. Revise and improve the classification catalog. According to the "In Vitro Diagnostic Reagent Classification Rules", revise the in vitro diagnostic reagent classification catalog, improve the classification framework, refine the classification hierarchy, standardize the expected use, expand representative products, and expand the coverage of the catalog. Improve the Classification Catalog of Medical Devices and the Category I Product Catalog of Medical Devices, strengthen the organic connection between product classification and generic name naming, establish the classification and naming database of medical devices, and ensure the effective implementation of classification and Naming convention.
（3） Improve classification management efficiency
5. Optimize the classification and definition work procedures. Standardize the classification and definition of medical device products, refine the division of responsibilities, and further optimize work processes. Improve the classification and definition of application data requirements and review points, smooth communication channels for applicants, and clarify work time requirements. Quickly research and define product attributes and management categories for related products that are urgently needed for public health emergencies and regulatory needs. Set up special procedures for classifying and defining situations such as inspection and handling cases, petition reporting, etc.
6. Implement a dynamic adjustment system for classification catalogs. Encourage medical device registrants/recorders, operating and using units, regulatory authorities, associations and societies, etc. to propose suggestions for dynamic adjustment of classification catalogs in accordance with the "Work Procedure for Dynamic Adjustment of Medical Device Classification Catalogues". Taking into account the changes in product risk, the ability to review and approve, and the needs of post market supervision throughout the entire lifecycle, we will scientifically, reasonably, and orderly adjust the management categories of medical device products, optimize the allocation of regulatory resources, unleash industry vitality, and effectively control product risks.
（4） Improve classification management capabilities
7. Strengthen research on classification technology. Focusing on the development of international cutting-edge technologies, focusing on the "choke point" problem of industrial innovation and development, strengthening the Prospective cohort study of classification management policies in emerging technology fields, carrying out targeted research on related topics of classification management, timely studying and releasing interpretations on hot spots, difficult problems and common problems involved in classification management, and further strengthening the guidance of medical device classification in related fields.
8. Strengthen research on classification work. Strengthen research on classification related work, promptly study and develop scientific and reasonable solutions to the problems found in the research, and improve the efficiency of classification management work. Fully leverage the role of associations and societies, timely collect industry attention, analyze, evaluate, organize research, clarify opinions, and improve the initiative of classification work.
9. Increase the promotion and implementation of classified training. Fully leverage the professional advantages of the Classification Technical Committee, regularly carry out publicity and implementation training on classification rules, guiding principles for classification definition, classification directories, and other relevant systems, policies, and documents, enrich training forms, expand training channels, highlight the pertinence and practicality of training, and further enhance the cognitive ability and level of various relevant parties on classification work.
（5） Improve the level of classification management services
10. Strengthen the construction of information technology for classification and definition. Further strengthen the functional construction of the medical device classification and definition information system, optimize the workflow of online application and information query methods for medical device classification and definition, continuously improve the standardization and convenience level of online application work, establish a coordination mechanism for medical device classification data sharing, and promote the sharing of classification information resources.
11. Strengthen the disclosure of classified and defined information. Strictly implement the classification and definition information disclosure mechanism, actively disclose classification related policy documents, classification directories, and dynamically adjust information, interpret classification related policy documents, timely disclose classification and definition information, and ensure the fairness and transparency of classification and definition work.
（6） Strengthen supervision of classification implementation
12. Implement the main responsibility. According to the needs of product registration and filing, applicants can apply for classification and definition according to the procedures. Applicants should fulfill their main responsibilities, standardize the submission of classified and defined application materials, and ensure the legality, authenticity, accuracy, completeness, and traceability of the materials. In principle, the content of product registration application/filing materials should be consistent with the content of classification and definition application materials. Registrants, registrants, and related enterprises should strengthen their learning of classification related knowledge, closely monitor the adjustment of product management categories, and ensure that registration, filing, production, and operation comply with the relevant requirements of medical device classification and supervision.
13. Strengthen regulatory responsibilities. Strictly implement product registration or filing in accordance with classification management requirements. If it is found during the supervision and inspection that the registrant/registrant has failed to comply with the classification management requirements, or if the actual production of the product is inconsistent with the registration/filing management category, it shall be dealt with in accordance with the law and regulations. Strengthen the supervision and guidance of lower level drug supervision and management departments, timely carry out retrospective inspections of registered and registered products, correct behaviors such as high class, low batch/standby, and non medical devices being registered/registered as medical devices, and effectively maintain the unity and authority of medical device product classification management.
3、 Safeguard measures
（1） Strengthen organizational leadership
Provincial drug regulatory departments and relevant units should attach great importance to the classification management of medical devices, further unify their thinking, fully recognize that classification management is the technical foundation for implementing medical device risk management, an important prerequisite for achieving scientific supervision, an effective means of optimizing regulatory resource allocation, releasing industrial vitality, and an important support for strictly adhering to the safety bottom line and promoting development high line. Effectively strengthen the organizational leadership of classification management, and do a solid job in all aspects of classification management in accordance with the deployment requirements of the National Drug Administration.
（2） Improve the working mechanism
Each provincial-level drug regulatory department and relevant units should further strengthen the classification management of medical devices, closely connect with reality, establish a scientific and smooth internal working mechanism and coordination mechanism, form a working force, and effectively improve the quality and efficiency of medical device classification management. We need to improve the consultation mechanism for classification management experts, actively leverage the advantages of the classification technical committee experts, enrich the expert consultation force of provincial drug supervision and management departments through various methods such as classification training, practical guidance, and experience exchange, strengthen the communication and exchange mechanism for provincial and national classification management experts, and promote the nationwide "one game" of classification work.
（3） Strengthen publicity and guidance
All provincial drug regulatory departments and relevant units should vigorously expand publicity channels, innovate publicity methods, fully leverage the professional expertise of classification management experts, further increase the popularization of knowledge related to medical device classification, and fully support and guide medical device registrants, registrants, and related enterprises to strictly implement the requirements of classification management through policy guidance, scientific supervision, and optimization of services. We should actively carry out the interpretation of hot and difficult issues that involve a wide range of topics and receive high social attention, respond to social concerns, focus on creating a unified and transparent policy environment for the classification management of medical devices, and create a scientific and standardized working atmosphere.
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