[Industry Information] Soliciting opinions on the revised draft of "Catalogue of Medical Devices of

Issuing time:2021-09-25 22:40

On August 18, the State Food and Drug Administration publicly solicited opinions on the "Draft Revision of the Category I Medical Device Product Catalog (Draft for Solicitation of Comments)" (hereinafter referred to as the "Draft for Solicitation of Comments"). The deadline for soliciting comments is September 10.




In 2017, the former State Food and Drug Administration released the "Catalogue of Medical Devices Classification" (hereinafter referred to as the 2017 "Catalog"), which came into effect on August 1, 2018, and provided policies for the filing and management of Class I medical devices. Basis and technical support. In recent years, with the rapid development of the medical device industry, product categories have become increasingly abundant, and new materials, new technologies, and new products have continued to emerge. The State Food and Drug Administration has successively issued relevant documents on the classification of medical devices, standardizing and supplementing the classification information of the first category of medical devices. At present, in addition to the 2017 version of the Catalog, the classification judgment basis for the first category of medical devices also exists in various forms such as classification definition documents and product definition information. In order to further improve the category 1 medical device product catalog and guide the grassroots to carry out the filing and supervision of category 1 medical devices, the State Food and Drug Administration organized the revision of the category 1 medical device product catalog.




   The "Draft for Comment" involved 19 sub-categories in the 2017 version of the "Catalogue", 120 first-level product categories, 368 second-level product categories, and 2,689 product name examples. Compared with the 2017 version of the "Catalog", 186 product information has been added, involving 600 examples of new product names. It should be noted that the "Draft for Comments" does not include in vitro diagnostic reagents and device combination packages.




The "Draft for Solicitation of Comments" uses the 2017 version of the "Catalog" as the main framework to sort out and integrate the information of the first type of medical device products in related documents. Product descriptions and intended uses belong to the same product and merge with the 2017 version of the "Catalog" as much as possible. Examples of product names have been added to the 2017 "Catalog", and specific items that cannot be combined are listed separately. In principle, the first category medical device product information in the summary of the classification and definition results of five batches of medical device products from 2018 to 2020 is retained . The product description and intended use in the "Draft for Comments" include all the core elements of the first-class medical device products that are clearly defined by laws and regulations, and at the same time try to cover all current first-class medical device product information and product name examples. The examples of product names are in principle in accordance with the "Guiding Principles for Naming Common Names of Medical Devices".



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