In order to implement the requirements of the “Regulations on the Supervision and Administration of Medical Devices” (Decree No. 739 of the State Council) regarding the classified management of medical devices, deepen the reform of the medical device review and approval system, further guide the filing of Class I medical devices, and boost the development of the medical device industry Quality development, the State Drug Administration organized the revision of the “Class I Medical Device Product Catalog”.
1. Revision background
In 2014, the State Food and Drug Administration issued the “Class I Medical Device Catalog” (hereinafter referred to as the 2014 version of the first class catalog), and in 2017, it revised and released the “Medical Device Classification Catalog” (hereinafter referred to as the 2017 version of the catalog). The filing management of similar medical devices provides effective policy basis and technical support, and plays a positive role in promoting the supervision of medical devices and the development of the industry. In recent years, with the rapid development of the medical device industry and the emergence of new materials, new technologies, and new products, the 2014 version of the first-class 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.
2. The revision process
On the basis of comprehensively sorting out the current effective catalogs, documents and product classification information related to the classification of Class I medical devices, study and learn from the relevant regulations, classification rules, market access procedures and post-marketing regulations of low-risk medical devices in Europe, America and Japan. Regulatory measures, combined with the outstanding problems found in the filing of the first-class medical device products, listening to the opinions of relevant experts, checking and sorting out the catalog item by item, technical research and judgment, and checking for omissions to fill in the gaps, form a revised draft of the “Class I Medical Device Product Catalog” (solicit opinions draft). From August 17, 2021 to September 10, 2021, public opinions will be solicited from the public, and opinions from relevant supervision, review, filing and other departments will be solicited many times, and the “Class I Medical Device Product Catalog” (revised draft for review) will be revised and formed. After deliberation by the professional group meeting of the Medical Device Classification Technical Committee, it was further revised and improved to form the newly revised “Class I Medical Device Product Catalog” (hereinafter referred to as the new “Class I Catalog”).
3. Amendments
The new “Class I Catalog” takes the 2017 version of the catalog as the main frame, including 19 sub-categories in the 2017 version of the catalog, 119 first-level product categories, 368 second-level product categories, and 2,629 product name examples. Compared with the 2017 version of the catalog, 90 product information items have been added, and 538 new product name examples have been added. The specific amendments are as follows:
(1) Sorting out and integrating the product information of Class I medical devices in the 2014 version of the Class I catalog, the 2017 version of the catalog, and the relevant medical device classification definition documents released previously.
(2) Sorting and summarizing the classification and definition information of Class I medical device products in the summary of classification and definition results of a total of five batches of medical device products from 2018 to 2020. In principle, retain the information that has been verified for product filing, and standardize product descriptions, Intended use and product name; information that has been verified and has no related product filings has not been included in the new “Class I Catalog”.
(3) The product description and intended use in the new “Class I Catalog” include the core determination elements of Class I medical device products, while trying to cover the current Class I medical device product information and product name examples. The examples of product names are in principle in line with the “Guidelines for the Naming of Generic Names of Medical Devices”.
(4) Explanations are attached to each sub-category in the new “Class I Catalog”, clarifying the revised content of the sub-category and precautions for product filing.
(5) Compiled the “Catalogue of Prohibited Additions to Certain Class I Medical Device Products” as an appendix, stipulating “09-02-03 Physical Cooling Equipment” and “09-03-08 Phototherapy Equipment Accessories” in the new “Class I Catalog” Products in “14-10-02 Band-Aids” and “20-03-11 Acupoint Pressure Stimulators” cannot contain traditional Chinese medicines, chemical drugs, biological products, disinfection and antibacterial ingredients, natural plants and their extracts, etc. Ingredients that have biological and metabolic effects or ingredients that can be absorbed by the human body, including but not limited to the ingredients listed in the appendix table, further standardize the filing of related products.
(6) The scope of physical cooling products is limited. The product description, intended use and product name examples of the third entry of “09-02-03 Physical Cooling Equipment” in the 2017 version of the catalog have been standardized and revised. In addition to limiting the composition, the intended use is limited For “local cooling of febrile patients. Only for intact skin on the body surface”, “medical cold compress patch, medical cold compress headband, medical cold compress eye mask, cold compress gel” is deleted in terms of product name examples. And it is clearly required that when such products are filed, they should directly use the “product name example” name in the catalogue, and the product description should list the specific components of the product in detail, and the intended use should not exceed the expected use specified in the catalogue, further standardizing the filing of such products, Purify the market environment.
(7) The content about liquid dressings and ointment dressings has been deleted. Delete the third entry in the 2017 edition catalog “14-10-08 Liquid and ointment dressings”, that is, non-sterile supply, forming a protective layer on the surface of the wound, which acts as a physical barrier, and is used for small wounds, abrasions, Liquid and ointment dressings for superficial wounds such as cut wounds and the care of surrounding skin are not included in the new “Class I Catalog”.
4. Other circumstances that need to be explained
(1) Since the relevant fields do not include products managed as Class I medical devices, the new “Class I Catalog” does not involve the sub-categories of “12 Active Implantable Devices, 13 Passive 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 package products.
(4) When “composed of” is used under the product description item in the new “Class I Catalog”, the relevant content only gives the representative composition structure of the product, and the specific composition of the product should be clarified when the product is filed. When “generally made of…” is used under the product description, the relevant content only gives the representative material of the product, and the specific material of the product should be specified when the product is filed.