​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.

​4 new guidelines have been released by CFDA from February 25th to March 3rd. Even though they are called guidelines, once they are released, you are expected to comply with them whether your products are in the review phase or new submissions. If you need any detailed information regarding these guidelines and how they impact your devices in China, please contact us at info@cfdahotline.com.