The China FDA unveiled long-awaited medical device clinical trial guidelines. They should provide some clarity to devicemakers, who wish they didn't have to conduct them at all, due to similar, arguably duplicative requirements in Europe, the U.S. and Japan. Topics covered in the guidance include preparation criteria, informed consent and data management. It appears that the list of devices subject to the clinical trial requirement is quite lengthy, to the chagrin of industry. But now at least companies will have a better sense of how to run their trials in the country. Several innovative devices like TAVRs from Medtronic and Edwards are not yet approved in China due to the need for clinical trials (although a local player has approval). Despite the obstacles, foreign interest in the fast-growing market remains quite high, as evidenced by Lilly Asia Ventures' recent investment in a Beijing-based Millin Enterprises, focused on devices and services to treat hemodialysis. More from FiercePharmaAsia | More about Eli Lilly's investment