Global Medtech Guidance Tracker: June 2019
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Twenty-four new guidance documents have been posted on the tracker since its last update.
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The Canadian regulator says that medical device manufacturers must demonstrate in their premarket license or license amendment applications that adequate provisions are in place to monitor, prevent and respond to post‐market cybersecurity events.
A new draft guideline explains how sponsors of subsequent-entry orally inhaled drug products can comply with the Canadian requirement for demonstrating equivalence to the reference product.
While good clinical practice inspectors in the UK and the US collaborate on matters of common interest, they say that mutual recognition is simply not possible.