Global Medtech Guidance Tracker: October 2019
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Twenty-seven guidance documents have been posted on the tracker since its last update.
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Lawyers Vladimir Murovec and Annabelle Bruyndonckx from Simmons & Simmons explain why the European Commission’s recently published software guidance falls short of what the EU medtech industry needs. They describe it as an afterthought and lacking legal review compared to previous MDCG guidelines.
The World Health Organization has proposed changes to its 2016 guideline on data integrity requirements to provide streamlined information to sponsors and to take account of experience gained to date.
EU regulators say that sponsors must complete their nitrosamine-related risk evaluations for all EU medicines containing chemically-synthesised active substances within the six-month timeframe.