Guangdong food and Drug Administration issued 20 measures to comprehensively speed up the review and approval of medical device registration

Guangdong Drug Administration held a press conference to introduce the recently issued “several measures of Guangdong Drug Administration on optimizing the registration, review and approval of class II medical devices”. The main contents include: optimizing the process and realizing 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. Implement special guidance services for products applying for innovation and identifying innovation, provide technical support for performance index evaluation and test method verification, and provide services such as connection of clinical trial institutions and guidance of clinical trial scheme for projects requiring clinical trial. Establish a research review linkage mechanism to support innovative product enterprises to submit R & D materials according to phased research progress.