Global Medtech Guidance Tracker: May 2023
Executive Summary
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-seven documents have been posted on the tracker since its last update.
You may also be interested in...
EC Guidance Document Details Notification Process For Clinical Investigation Reports
The Medical Device Regulation requires sponsors of clinical investigations to file a summary of their report shortly after study completion. The commission explains the steps and the need for conciseness.
Decentralized Clinical Trial Guidance Fulfills Promise, Underlies Digitization Of Healthcare
The FDA’s long-awaited guidance on decentralized clinical trials underscores the importance of digital health tech in clinical trials.
EU Regulators Explain How To Ensure Transitioned Trials Align With CTR
Members of the EU’s Clinical Trials Coordination Group have developed harmonized requirements for updating trials that are transitioned to the Clinical Trials Information System based on a minimum set of documents.