● recently, the State Drug Administration issued the working procedure for dynamic adjustment of medical device classification catalogue, which laid a foundation for standardizing the dynamic adjustment of medical device classification catalogue and guiding the classification of medical devices.
● the working procedure defines the contents of dynamic adjustment of classification catalogue, the submission way, material requirements, processing flow, adjustment frequency and other core contents of adjustment suggestions.
● the dynamic adjustment of classified catalogue will become a normal work. To do this work well, all sectors of society need to actively participate, make concerted efforts and put forward useful suggestions from different angles.
In order to strengthen the classification management of medical devices and standardize the dynamic adjustment of the classification catalogue of medical devices (hereinafter referred to as the classification catalogue), according to the relevant requirements of the newly revised regulations on the supervision and administration of medical devices (hereinafter referred to as the newly revised regulations) and the classification rules of medical devices, recently, The State Drug Administration issued the working procedure for the dynamic adjustment of the classified catalogue of medical devices (hereinafter referred to as the working procedure), which laid a foundation for standardizing the dynamic adjustment of the classified catalogue and guiding the classification of medical devices.
Meet the needs of supervision and industrial development
In 2017, the general office of the CPC Central Committee 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, which required to speed up the listing review of clinically urgently needed drugs and medical devices. Scientific classified management of medical devices and rational allocation of regulatory resources are not only an effective measure to vigorously improve the ability and level of "release, management and service", but also the basis and guarantee to accelerate the listing of clinical 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, the registration or filing systems of different management categories of medical devices are different, the departments responsible for registration or filing review are different, and the corresponding regulatory policies are also different. For the supervision of medical devices, China implements the classification catalogue system under the guidance of classification rules. The classification catalogue is the regulation of the management categories of medical devices and an important basis for the supervision of medical devices《 The classified catalogue is formulated based on the regulatory practice and industrial development status in a certain period of time. The medical device industry is in the dynamic transformation of continuous innovation and development. The classified catalogue should timely meet the needs of supervision and industrial development. According to the current situation of medical device technology and industry development, combined with the regulatory needs, the classified catalogue is dynamically adjusted in time according to the procedures, which is much more efficient and meaningful than the previous revision of the classified catalogue once in more than 10 years, which is also one of the important measures to further deepen the reform of the review and approval system of medical devices.
Article 6 of the newly revised Regulations stipulates that "the drug regulatory department of the State Council shall be responsible for formulating the classification rules and classification catalogue of medical devices, timely analyzing and evaluating the risk changes of medical devices according to the production, operation and use of medical devices, and adjusting the classification rules and classification catalogue". In addition, the notice on regulating the work related to the classification of medical devices (hereinafter referred to as the notice) also stipulates the dynamic adjustment of the classification catalogue. In December 2020, the State Food and Drug Administration issued the announcement on adjusting part of the contents of < medical device classification catalogue >, and the announcement on adjusting part of the contents of < 6840 in vitro diagnostic reagent classification sub catalogue (2013 Edition), which adjusted the management categories of 28 categories of medical devices and 29 categories of in vitro diagnostic reagents. This is the first attempt to dynamically adjust the classification catalogue, and the industry has had a strong response. In order to carry out the dynamic adjustment of the classified catalogue more scientifically and standardized, the working procedure came into being.
Clarify multiple core contents
The dynamic adjustment of the classified catalogue shall be based on the risk changes of medical devices, refer to international experience, follow the principles of conforming to the latest scientific cognition, based on the actual supervision, encouraging innovation and promoting the high-quality development of the industry. Its core contents include the contents of dynamic adjustment, the submission methods, material requirements, treatment processes and adjustment frequency of adjustment suggestions.
The contents of dynamic adjustment in the classified catalogue basically include the contents related to product management categories and attributes in the classified catalogue. According to the problems found during the implementation of the classified catalogue, changes in the risk degree of medical device products and the needs of supervision, the sub catalogue framework, primary and secondary product contents and management categories in the classified catalogue can be adjusted according to the actual situation, which can add representative innovative medical device products, Products that are no longer managed as medical devices can also be deleted from the catalog. Among them, "adding representative innovative medical device products" is a prominent embodiment of encouraging technological innovation of medical devices.
The dynamic adjustment suggestions of the classified catalogue are submitted from the classified definition information system of the medical device standard management center of the State Food and Drug Administration (hereinafter referred to as the standard management center), which is divided into two ways. First, domestic medical device registrants and recorders, production and operation enterprises, users, and overseas medical device registrants and recorders can put forward adjustment suggestions directly and through domestic agents to the drug regulatory department of the province (District, city) where they are located. The drug regulatory department of the province (District, city) is responsible for the preliminary review of the adjustment suggestions. If it is considered that adjustment is really necessary, Report the adjustment suggestions to the standard management center. Second, relevant departments of the State Food and drug administration, provincial (District, municipal) drug regulatory departments, social groups related to medical devices, and members of the medical device classification technical committee can directly put forward adjustment suggestions on the classification catalogue to the standard management center.
The work procedure clearly stipulates the supporting materials to be submitted when making adjustment suggestions, including the contents and reasons for the adjustment, the management attributes, categories and industrial status of the products at home and abroad, the main risk points and risk changes of the products, the technical characteristics, comparison with similar products on the market and clinical use of the products, It is proposed to adjust the product adverse events and post marketing supervision (if applicable). These requirements help to ensure that there is evidence to rely on in the subsequent processing of adjustment suggestions, and help to improve the scientificity and rationality of the processing of adjustment suggestions. At the same time, it should also be noted that "product description" and "intended use" in the catalogue are general descriptions of one or a class of products, and "product name examples" are not exhaustive methods, but only examples of representative product specification names, which cannot cover all relevant 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 classification catalog. As long as the key technical information related to the product classification is not essentially different from the content described in the classification catalog, the product can be considered to be within the scope of the classification catalog, It is not necessary to "add primary / secondary product categories" and "add product name examples".
The working procedure clearly stipulates the processing procedures and adjustment cycle of dynamic adjustment suggestions of the classification catalogue《 The preliminary adjustment opinions of the classified catalogue will be solicited from the public on the website of the standard management center for one month, and the proposed adjustment opinions of the classified catalogue reviewed by the Executive Committee of the classified Technical Committee will be publicized on the website of the State Food and Drug Administration for 7 days. Such an adjustment procedure highlights openness, impartiality, transparency and authority, which is conducive to ensuring the scientificity of the dynamic adjustment of the classified catalogue.
In addition, the working procedure also stipulates the adjustment of the classified catalogue database and registered / filed products, effectively ensuring the smooth connection between dynamic adjustment and registration approval. For the frequency of dynamic adjustment, the work procedure is clear, and the adjustment of classified catalogue shall not be less than once a year《 The dynamic adjustment of 6840 in vitro diagnostic reagent classification subdirectory shall also refer to the working procedure.
Multi party participation in implementation
At present, the working procedures, the newly revised regulations, the notice and the working rules of the medical device classification Technical Committee of the State Food and Drug Administration constitute a relatively complete system of laws and regulations for dynamic adjustment of the classification catalogue, with detailed provisions on the competent departments, work responsibilities, work contents and work processes, At the system level, effectively ensure the smooth development of the dynamic adjustment of the classified catalogue. On the basis of certain achievements in the early stage, according to the needs of industrial development and supervision, the dynamic adjustment of the classified catalogue will become the normal work. To do a good job in the dynamic adjustment of the classified catalogue, we need the active participation of all sectors of society, make concerted efforts and put forward useful suggestions from different angles.
It is believed that taking the release and implementation of the working procedures as an opportunity, under the strong leadership of the State Food and drug administration, the cooperation of relevant departments and the strong support of the industry, the dynamic adjustment of the classified catalogue will orderly promote the classified management of China''s medical devices in line with international standards, and effectively ensure the healthy development of China''s medical device industry and the safety of public devices.
(author: medical device standard management center of the State Drug Administration)