Global Medtech Guidance Tracker: December 2019
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-one guidance documents have been posted on the tracker since its last update.
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Not only is the EU due to be endorsing key guidance documents this week, but recent headline topics, including appointing expert panels and the delay in setting up the Eudamed database feature on end of week Medical Devices Coordination Group meeting agenda.
Swissmedic will scale back its review procedure for certain anti-infectives if the indications for which approval is being sought are identical to those approved in the EU or the US.
Based on the operational experience gained using the new international standard for reporting suspected adverse reactions in EudraVigilance, the EU has decided to set a date for its mandatory use.