State Food and Drug Administration's latest notice: 1418 medical devices and reagents are exempted from clinical trials!

By Xiao Meng Make up ginger In order to implement the opinions of the general office of the CPC Central Committee and the general office of the State Council on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical and medical devices, and the requirements of the State Council on deepening the reform of the "release management service", and further improve the registration and management of medical devices, according to the regulations on the supervision and management of medical devices, the measures for the registration and management of medical devices, and the registration and Management Office of in vitro diagnostic reagents Law of the people's Republic of China, on December 20, 2019, the State Drug Administration issued the newly added and revised catalogue of medical devices exempt from clinical trials, and the newly added and revised catalogue of in vitro diagnostic reagents exempt from clinical trials (hereinafter referred to as the 2019 edition of the revised catalogue of exemption) The regulation on the supervision and administration of medical devices (No 650 order of the State Council) was issued in 2014, in which class I medical device products are required to be filed without clinical trials; class II and class III medical device products need to submit clinical evaluation data when they are registered The measures for the administration of registration of medical devices and the measures for the administration of registration of in vitro diagnostic reagents issued by the State Administration describe that the class II and class III medical devices and in vitro diagnostic reagents need to undergo clinical trials, and those meeting the following conditions can be exempted from clinical trials: Table 1 current exemption conditions of traditional Chinese medical instruments and reagents According to the description of the conditions for exemption of clinical trials in the measures for the administration of registration of medical devices, the first is that the exemption of clinical trials of medical devices is completely consistent with the description in the exemption catalogue, and the second is that the products not in the exemption catalogue can be compared with the same varieties, but through the comparison of the same varieties, it is necessary to obtain the relevant data of the same varieties (including working principle / mechanism, structure and composition Materials, scope of application, performance, production process and clinical trial data, etc.), which are not publicly disclosed, also need the authorization of the other party, so now only the same kind of products of the same company or group, acquisition of related companies, etc use this method, and other situations are more difficult to operate in practice Therefore, the increase of exemption catalogue has greatly helped enterprises to put their products on the market On December 20, 2019, the 2019 edition of the revised exemption catalogue was issued, which revised 48 medical device products, including 28 class II medical device products, 20 class III medical device products, and 4 class II in vitro diagnostic reagent products At the same time, on the basis of the 2018 new exemption catalogue, 147 new medical device products and 23 new in vitro diagnostic reagent products are added respectively Now there are 1002 new medical device products and 416 new in vitro diagnostic reagent products, with a total of 1418 new ones Figure 1 Distribution of new medical devices and reagent types in exemption catalogue in December 2019 For the newly added items in the 2019 edition of the exemption catalogue of medical device products, it is clear that "the medical device products of class I medical device catalog upgraded to class II medical device catalog after sterilization, which do not generate new risks or reduce the degree of risks after sterilization, can be exempted from clinical trials" In terms of revision, most of them are in terms of product description and expanded scope of exemption In addition, 2 items modify product name and 3 items modify classification code In the 2019 edition of the revised exemption catalogue, it is emphasized that "the intended use in the catalogue is products related to patient self-test or newborn detection, which are not within the scope of products exempt from clinical trials", "general counting reagents (counting tube, counting microsphere) for flow cytometry, test condition setting reagents (fluorescence compensation microsphere) and other class II products exempt from clinical trials." Clinical trial); in terms of revision, the product description and name of 4 in vitro diagnostic reagents were revised Currently, there are 1002 exempted medical device products, involving 21 subdirectories, of which 12 active implant devices have not entered the exempted catalogue In addition, class II products in the disinfection and sterilization neutron catalog of 11 medical devices are exempt from clinical trials There are 15 medical device products, 14 class II medical devices and 1 class I medical device in the disinfection and sterilization neutron catalog of 11 medical devices According to the description in the exemption catalog, all 15 medical device products in the disinfection and sterilization neutron catalog of 11 medical devices are exempt from clinical trials Products Among them, the number of infusion, nursing and protective devices was the largest, 161, accounting for 16% Table 2 exemption quantity of different types of medical devices in the current exemption catalogue There are 416 exempted in vitro diagnostic reagent products, involving 13 in vitro diagnostic reagent product categories (11 class II products, 3 class III products) Among them, there are 77 reagents (18.5%) used for autoantibody test and 76 reagents (18.3%) used for microbial identification or drug sensitivity test Table 3 exemption quantity of different types of IVD reagents