CFDA issued a new guideline for document preparation of innovative medical device special approval process on Dec. 15, 2016. The initial general decree that governs the general requirements of innovation approval was first issued on Feb. 7, 2014. Since then, a series of documents have spelled out the reviewing and feedback process. CFDA gained more experience in the past 2 years after more than 400 products have been submitted.
This new guideline provides more details to regulate the preparation and writing of documents for the special approval of innovative medical device.