Interpretation of the revision of the 'Catalog of Class I Medical Devices': Liquid dressings and paste-like auxiliary materials are removed, and in vitro diagnostic reagents are not included.

    In order to implement the requirements of the 'Regulations on the Supervision and Administration of Medical Devices' (State Council Order No. 739) regarding the classification management of medical devices, deepen the reform of the review and approval system for medical devices, further guide the filing work of Class I medical devices, and promote the high-quality development of the medical device industry, the National Medical Products Administration organized the revision of the 'Catalog of Class I Medical Devices'.

I. Background of the Revision

　　In 2014, the National Food and Drug Administration issued the 'Catalog of Class I Medical Devices' (hereinafter referred to as the 2014 version of the Class I catalog), and in 2017, the 'Catalog of Medical Devices' (hereinafter referred to as the 2017 version of the catalog) was comprehensively revised and published, providing effective policy basis and technical support for the filing management of Class I medical devices, and playing a positive role in promoting the regulation of medical devices and the development of the industry. In recent years, with the rapid development of the medical device industry, new materials, new technologies, and new products have emerged continuously.The 2014 version of the Class I catalog and the 2017 version of the catalog can no longer fully meet the needs of product classification and filing. The catalog of Class I medical devices urgently needs to be revised..

II. Revision Process

　　Based on a comprehensive review of the current effective catalogs, documents, and product classification definitions related to Class I medical devices, research and reference to relevant regulations, classification rules, market access processes, and post-market supervision measures for low-risk medical devices in Europe, America, and Japan, combined with prominent issues found in the filing of Class I medical devices, expert opinions were solicited, and the catalog was checked and sorted item by item, with technical assessments and gap-filling conducted, resulting in the draft revision of the 'Catalog of Class I Medical Devices' (draft for public consultation). From August 17 to September 10, 2021, public opinions were solicited, and opinions from relevant regulatory, review, and filing departments were repeatedly sought, leading to modifications and the formation of the 'Catalog of Class I Medical Devices' (revised draft for review), which was further modified and improved after deliberation by the professional group meeting of the Medical Device Classification Technical Committee, resulting in the newly revised 'Catalog of Class I Medical Devices' (hereinafter referred to as the new 'Class I catalog').

III. Revision Content

　　The new 'Class I catalog'is based on the framework of the 2017 version of the catalog, including 19 subdirectories, 119 first-level product categories, and 368 second-level product categories from the 2017 version of the catalog, with 2,629 examples of product names. Compared to the 2017 version of the catalog,90 product information entries have been added, and 538 new examples of product names have been introduced.The specific revision content is as follows:

　　(1) The product information of Class I medical devices in the 2014 version of the Class I catalog, the 2017 version of the catalog, and previously published relevant medical device classification definition documents has been sorted and integrated.

　　(2) The classification definition information of Class I medical devices from five batches of medical device product classification results from 2018 to 2020 has been summarized. For information verified to have product filings, it will generally be retained, with standardized product descriptions, intended uses, and product names; for information verified to have no relevant product filings, it will not be included in the new 'Class I catalog'.

　　(3) The product descriptions and intended uses in the new 'Class I catalog' include the core determination elements of Class I medical devices, while also covering the current information and examples of product names for Class I medical devices as much as possible. The examples of product names generally comply with the 'Guiding Principles for the Naming of Medical Device Generic Names'.

　　(4) Each subdirectory in the new 'Class I catalog' is accompanied by explanations, clarifying the revision content of the subdirectories and the precautions for product filing.

　　(5) A 'List of Prohibited Ingredients for Certain Class I Medical Devices' has been prepared as an appendix, stipulating that products in the new 'Class I catalog' under '09-02-03 Physical Cooling Equipment', '09-03-08 Light Therapy Device Accessories', '14-10-02 Adhesive Bandages', and '20-03-11 Acupoint Pressure Stimulators' cannot contain ingredients that exert pharmacological, immunological, or metabolic effects, or components that can be absorbed by the human body, including but not limited to the ingredients listed in the appendix table, further standardizing the filing of related products.(6) The scope of physical cooling products has been limited.

　　The product description, intended use, and examples of product names for the third item under '09-02-03 Physical Cooling Equipment' in the 2017 version of the catalog have been standardized and modified. In addition to limiting the ingredients, the intended use has been specified as 'for local cooling of febrile patients. Only for intact skin on the body surface.'In terms of examples of product names, 'Medical Cold Compress, Medical Cold Compress Headband, Medical Cold Compress Eye Mask, Cold Compress Gel' have been deleted.It is also clearly required that when filing such products, the 'examples of product names' in the catalog should be used directly, and the product description should detail the specific composition of the product, and the intended use should not exceed the intended use specified in the catalog, further standardizing the filing of such products and purifying the market environment.(7)The content related to liquid dressings and paste-like dressings has been deleted.

　　The third item in '14-10-08 Liquid and Paste Dressings' from the 2017 version of the catalog has been deleted, namelyliquid and paste dressings that are non-sterile, form a protective layer on the surface of the wound, serve as a physical barrier, and are used for the care of small wounds, abrasions, cuts, and other superficial wounds and surrounding skin are not included in the new 'Class I catalog'.IV. Other Situations That Need Explanation(1) Since the relevant fields do not include products managed as Class I medical devices, the new 'Class I catalog' does not involve the subdirectories of '12 Active Implantable Devices, 13 Non-active Implantable Devices, and 21 Medical Software'..

(2)

　　The new 'Class I catalog' does not include in vitro diagnostic reagents.

　　(3)The new 'Class I catalog' does not include medical device combination products..

　　(4) When the product description in the new 'Class I catalog' uses 'usually composed of...', the relevant content only provides the representative composition structure of the product. When filing products, the specific composition of the product should be clarified. When the product description uses 'generally made of...', the relevant content only provides the representative material of the product,and when filing products, the specific material of the product should be clarified..

　　（四）当新《一类目录》中产品描述项下使用“通常由……组成”时，相关内容只给出了产品的代表性组成结构，产品备案时，应当明确产品的具体组成。当产品描述项下使用“一般采用……制成”时，相关内容只给出了产品的代表性材质，产品备案时，应当明确产品的具体材质.