CFDA Drafts a New Regulation for Medical Device Clinical Trial Inspection

June 1, 2018- The China Food and Drug Administration (CFDA) requested public comments on “Medical Device Clinical Trial Inspection Essentials and Decision Principles (Draft)”. This guidance is to strengthen the supervision and management of the medical device clinical trial. CFDA plans to begin conducting on-site inspections of clinical trials for medical devices in an effort to improve clinical data used in pre-market review decisions. Draft guidance is now open for comment, please reply before June 30, 2018.