Global Medtech Guidance Tracker: February 2022
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.
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A 20-day consultation on the risk classification of medical devices intended for the Malaysia market ends on 28 February
The highest risk IVDs, which fall into class D, are subject to additional testing criteria. New guidance explains how the notified body acts − not only as reviewer but also as facilitator so additional safety and performance guarantees can be sought.
The UK MHRA has approved its first drug under an international work-sharing initiative that also includes regulators from Australia, Canada, Singapore and Switzerland.