Global Medtech Guidance Tracker: May 2022
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-two documents have been posted on the tracker since its last update.
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The EU’s full implementation of the In Vitro Diagnostic Regulation on 26 May has put the Swiss IVD industry on a "third country" footing with the EU, as happened in 2021 for medical devices. The two parties’ mutual recognition agreement for all medtech products has ceased to apply. A renewed MRA is not likely for several years.
The draft document from the US agency looks to officially recognize a program aimed at advancing quality in medical devices and their manufacturing.
Four orphan drugs and a new COVID-19 vaccine are among the latest products that the European Medicines Agency says should be approved.