In Scrip Regulatory Affairs,Ropes & Gray Partner Comments on “User-friendly” Guidance on Medical Device Registration
In an article published by Scrip Regulatory Affairs, life sciences partner Katherine Wang comments on China FDA’s first time issued guidance that explains how medical device makers should conduct clinical evaluations of the products they seek to register in China and in which cases they may obtain a clinical study waiver. However,
Katherine anticipates that companies might not find it easy to benefit from the clinical trial waiver opportunity straight away.
This article was published in on May 29, 2015 and available here.