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Guidance Documents Regulation International

Global Medtech Guidance Tracker: May 2023

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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.

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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.

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The FDA’s long-awaited guidance on decentralized clinical trials underscores the importance of digital health tech in clinical trials.

Global Medtech Guidance Tracker: September 2023

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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