Notice of the State Food and Drug Administration on Issuing the catalogue of medical devices exempted from clinical trials (the second batch of amendments) (No. 3, 2021)
In September 2018, the State Drug Administration issued the notice on publishing the newly revised catalogue of medical devices exempted from clinical trials (No. 94, 2018), comprehensively revised and summarized the previously released catalogue of medical devices (and in vitro diagnostic reagents) exempted from clinical trials, and respectively issued the revised and summarized catalogue of medical devices exempted from clinical trials Contents of in vitro diagnostic reagents exempted from clinical trials. On this basis, in December 2019, the State Drug Administration issued the notice on publishing the new and revised medical device catalog exempted from clinical trials (No. 91, 2019), and announced the first batch of new and revised medical device (and in vitro diagnostic reagents) catalog exempted from clinical trials.
In order to implement the "opinions on deepening the reform of the review and approval system and encouraging the innovation of drugs and medical devices" issued by the general office of the CPC Central Committee and the general office of the State Council, and the relevant requirements of the State Council for deepening the reform of "release, management and service", and further improve the registration and management of medical devices, according to the "Regulations on the supervision and management of medical devices", "measures for the registration and management of medical devices" and "Regulations on the registration and management of in vitro diagnostic reagents" The second batch of medical devices (and in vitro diagnostic reagents) exempted from clinical trials were added and revised by the State Drug Administration. It is hereby promulgated and shall take effect as of the date of promulgation.
Notice is hereby given.
Annex: 1. List of medical devices exempted from clinical trials (revised in the second batch)
2. List of in vitro diagnostic reagents exempted from clinical trials (revised in the second batch)
State Food and Drug Administration
January 14, 2021
