Global Medtech Guidance Tracker: January 2022
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-eight documents have been posted on the tracker since its last update.
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The long-awaited guidance on how to collect and maintain clinical evidence for diagnostic tests under the IVDR has now been published. It reflects the need for a lifecycle approach to device development and regulation.
The 28 January guidance from the US FDA explains the premarket and submission process for combination products and offers tips to manufacturers as they consider which of the agency’s lead centers should review their product.
The UK MHRA has approved its first drug under an international work-sharing initiative that also includes regulators from Australia, Canada, Singapore and Switzerland.