Global Medtech Guidance Tracker: August 2021
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-nine documents have been posted on the tracker since its last update.
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Distributors and importers may just be repacking and relabeling devices and IVDs, without changing them. But these activities must still be carefully managed and audited. New EU guidance explains how.
Singapore’s devices regulator is seeking comments on recently issued draft guidance on a medical device Unique Device Identification system.
The UK medicines regulator has made changes to its guideline on pharmacovigilance procedures to ensure it can continue receiving all necessary safety information in a timely manner now that it has left the EU. It has also explained the safety reporting procedures for products marketed in Northern Ireland, which are still governed by EU medicines regulations.