Guangdong food and Drug Administration issued 20 measures to comprehensively optimize the review and approval of accelerating the registration of medical devices

On May 23, Guangdong Drug Administration held a press conference to introduce the recently issued Measures of Guangdong Drug Administration on optimizing the registration, review and approval of class II medical devices. The "several measures" has four parts and 20 articles. The main contents are as follows: first, optimize the process and realize overall speed-up. The time limit for technical review of product registration is more than 50% faster than the legal time limit, and the time limit for administrative examination and approval is 50%. Classify and standardize the product inspection cycle, disclose the inspection time limit and progress, and strengthen the supervision of inspection time limit. Second, it is classified and divided to improve the handling efficiency. Third, special channels to vigorously support innovation.