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Analysis of "Working Procedures for Dynamic Adjustment of Medical Device Classification Catalogue"

Issuing time:2021-06-28 13:47

●?Recently, the National Medical Products Administration issued the "Working Procedures for Dynamic Adjustment of the Medical Device Classification Catalogue", laying a foundation for standardizing the dynamic adjustment of the medical device classification catalog and guiding the work of medical device classification.



  ●?The working procedures clarify the content of the dynamic adjustment of the classification catalog, adjust the core content such as the suggested submission path, material requirements, processing flow, and adjustment frequency.



  ●? The dynamic adjustment of the classification catalog will become a normal work. To do this well requires the active participation of all sectors of the society, teamwork, and helpful suggestions from different angles.



In order to strengthen the classification management of medical devices, standardize the dynamic adjustment of the "Medical Device Classification Catalogue" (hereinafter referred to as the "Classification Catalogue"), according to the newly revised "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the newly revised "Regulations") "Medical Device Classification Rules" According to relevant requirements, the State Drug Administration recently released the "Working Procedures for the Dynamic Adjustment of the Medical Device Classification Catalogue" (hereinafter referred to as the "Working Procedures") to lay a foundation for standardizing the dynamic adjustment of the "Classification Catalogue" and guiding the classification of medical devices.



   Adapt to the needs of supervision and industrial development



   In 2017, the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council issued the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices", requesting to speed up the market review of urgently needed drugs and medical devices. Scientifically classified management of medical devices and reasonable allocation of regulatory resources are not only effective measures to vigorously improve the ability and level of decentralization, management and service, but also the basis and guarantee for promoting the rapid listing of clinically urgently needed medical devices. In recent years, the State Food and Drug Administration has successively issued regulatory documents and policy measures to effectively implement the reform requirements of the medical device review and approval system.



  According to the relevant provisions of the newly revised "Regulations", medical devices of different management categories have different registration or filing systems, and the departments responsible for registration or filing review are different, and the corresponding regulatory policies are also different. Regarding the supervision of medical devices, my country implements a classification catalog system under the guidance of classification rules. The "Classification Catalog" is the regulation of medical device management categories and is an important basis for medical device supervision. The "Category Catalogue" is formulated based on the regulatory practice and the status quo of industrial development in a certain period of time. The medical device industry is in a dynamic change of continuous innovation and development, and the "Category Catalog" should meet the needs of supervision and industrial development in a timely manner. According to the current status of medical device technology and industry development, combined with regulatory requirements, the "Classification Catalog" is dynamically adjusted in a timely manner according to procedures. The efficiency and significance are much higher than the previous revision of the "Classification Catalog" once more than 10 years ago. This is also a further deepening of medical treatment. One of the important measures for the reform of the device review and approval system.



Article 6 of the newly revised "Regulations" stipulates that "The State Council’s drug regulatory authority is responsible for formulating the classification rules and classification catalogs of medical devices, and according to the production, operation and use of medical devices, timely analysis and evaluation of the risk changes of medical devices, and Classification rules and classification catalogues are adjusted." In addition, the "Notice on Regulating the Work Related to the Classification of Medical Device Products" (hereinafter referred to as the "Notice") also provides for the dynamic adjustment of the "Category Catalog". In December 2020, the State Food and Drug Administration issued the "Announcement on Adjusting Part of the <Medical Device Classification Catalog>" and the "Announcement on Adjusting Part of the <6840 In Vitro Diagnostic Reagent Classification Sub-Catalogue (2013 Edition)>", with regard to 28 categories The management categories of medical devices and 29 types of in vitro diagnostic reagents have been adjusted. This is the first attempt to dynamically adjust the "Classification Catalog", and the industry has received strong responses. In order to carry out the dynamic adjustment of the "Classification Catalog" more scientifically and standardizedly, the "Working Procedures" came into being.



  Clarify multiple core content



The dynamic adjustment of the "Category Catalogue" should be based on changes in medical device risks, refer to international experience, and follow the principles of conforming to the latest scientific knowledge, based on regulatory reality, encouraging innovation, and promoting the high-quality development of the industry. Its core content includes dynamic adjustments and adjustments. Suggested submission channels, material requirements, processing procedures, and adjustment frequency, etc.



   The dynamically adjusted content of the "Category Catalog" basically includes the content related to the product management categories and attributes in the "Category Catalog". According to the problems found in the implementation of the "Classification Catalog", the changes in the degree of risk of medical device products and the needs of supervision work, the sub-category framework, the content of primary and secondary products, and the management categories in the "Classification Catalog" can be based on actual conditions. Adjustments can either add representative innovative medical device products, or delete products that are no longer managed as medical devices from the catalog. Among them, "adding representative innovative medical device products" is a prominent manifestation of encouraging technological innovation of medical devices.



   The dynamic adjustment suggestions of the "Classification Catalog" are submitted from the classification and definition information system of the Medical Device Standards Management Center of the State Drug Administration (hereinafter referred to as the Standard Management Center), which can be divided into two ways. First, domestic medical device registrants and recorders, production and operation enterprises, and users, as well as overseas medical device registrants and recorders, can directly and through domestic agents make adjustment suggestions to the drug regulatory authority of the province (region, city) where they are located. , The provincial (regional, municipal) drug regulatory department is responsible for the preliminary review of the adjustment proposal, and if it thinks that it is necessary to adjust, it will report the adjustment proposal to the standard management center. Second, the relevant departments of the State Drug Administration, provincial (regional, municipal) drug regulatory authorities, medical device-related social organizations, and members of the Medical Device Classification Technical Committee can directly submit suggestions for adjustments to the "Classification Catalog" to the Standards Management Center.



The "Working Procedures" clearly stipulates the supporting materials that should be submitted when making adjustment suggestions, including the content to be adjusted and the reasons for the adjustment, the domestic and foreign management attributes, categories and industry status of the proposed adjustment of the product, the main risk points and risk changes of the proposed adjustment of the product, etc. , It is proposed to adjust the technical characteristics of the product, the comparison with the similar products already on the market, and the clinical use, etc., and it is planned to adjust the adverse events of the product and the relevant situation of post-marketing supervision (if applicable), etc. These requirements help to ensure that the follow-up process of adjustment suggestions is based on evidence, and helps to improve the scientific and reasonable handling of adjustment suggestions. At the same time, it should be noted that the "product description" and "intended use" in the "Classification Catalog" are general descriptions of one or a class of products, and the "examples of product names" are not exhaustive methods, but only for representative product specifications. Examples of names may not cover all related product names. In specific practice, the description information of a specific medical device product does not need to be completely consistent with the content in the "Category Catalog", as long as the key technical information related to the product classification is not essentially different from the content in the "Category Catalog", that is It can be considered that the product is already within the scope of the "Category Catalog", and there is no need to "add first/second product categories" and "add examples of product names".



   The "Working Procedures" clearly stipulates the processing procedures and adjustment cycles for the dynamic adjustment recommendations of the "Category Catalog". The preliminary adjustment opinions of the "Classification Catalog" will be publicly solicited from the public on the website of the Standard Management Center for one month. The proposed adjustments of the "Classification Catalog" reviewed by the Executive Committee of the Classification Technical Committee will be published on the website of the State Food and Drug Administration for 7 days. Such an adjustment procedure highlights openness, fairness, transparency, and authority, and helps ensure the scientific nature of the dynamic adjustment of the "Category Catalog".



   In addition, the "Working Procedures" also made provisions for the adjustment of the "Classification Catalog" database and registered/recorded products, which effectively ensured the smooth connection of dynamic adjustments and registration approval. Regarding the frequency of dynamic adjustments, the "Working Procedures" is clear, and the "Category Catalog" is adjusted no less than once a year. The dynamic adjustment of the "6840 In Vitro Diagnostic Reagent Classification Sub-Catalogue" is also implemented with reference to the "Working Procedures".



  Multi-party participation in implementation



At present, the "Working Procedures", the newly revised "Regulations", "Notices" and the "Working Rules of the Medical Device Classification Technical Committee of the State Food and Drug Administration" constitute a relatively complete "Classification Catalog" dynamic adjustment of the regulatory system. The competent authorities, There are detailed regulations on work responsibilities, work content, and work procedures, which effectively ensure the smooth development of the dynamic adjustment of the "Category Catalog" at the system level. On the basis of certain results obtained in the early stage, according to the needs of industrial development and supervision, the dynamic adjustment of the "Category Catalog" will become a normal work. To do a good job in the dynamic adjustment of the "Category Catalog" requires the active participation of all sectors of society, teamwork, and helpful suggestions from different angles.



I believe that with the release and implementation of the "Working Procedures" as an opportunity, under the strong leadership of the State Drug Administration, with the cooperation of relevant departments and the strong support of the industry, the dynamic adjustment of the "Category Catalog" will advance the classification of medical devices in my country in an orderly manner. The management is in line with international standards to effectively guarantee the healthy development of my country's medical device industry and the safety of the public's use of equipment.


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