Global Medtech Guidance Tracker: June 2018
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-nine new guidance documents were posted on the tracker since its last update.
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The Singapore Health Sciences Authority says regulatory changes that will provide faster market access for class A and many class B devices kicked in on June 1. The requirements for telehealth devices and high-risk devices cosmetic devices have also been clarified.
Five new drugs have been recommended for EU approval at the latest meeting of European Medicines Agency’s drug evaluation committee.
The European Commission has set aside, for now, concerns expressed by member states regarding the scope of medicines subjected to additional monitoring requirements.