Global Regulatory Guidelines: Medtech Guidance Tracker, July 2016
Executive Summary
Stay up to date on regulatory guidelines from around the world, with Medtech Insight's Guidance Tracker, with documents updated through July 2016.
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[Editor's note: Check out the complete global Medtech Guidance Tracker with sortable and searchable listings going back to 2014 here.]
Fifteen new guidance documents on medical device and in vitro diagnostics from global regulatory authorities were added to Medtech Insight's Guidance Tracker in July. The most guidelines last month came from US FDA, with nine documents, including two draft guidelines on next generation sequencing.
Also on the updated list, a draft guideline from Malaysia explaining how change of ownership may impact the device registration process, and a revised final guideline from South Africa outlining essential principles of safety and performance of devices and IVDs.
The July guidance document listing is below, with links to each guideline.
Medtech Guidance Tracker: July 2016
Key:
- IMDRF: International Medical Device Regulators Forum
- WHO: World Health Organization
- EC: European Commission
- HPRA: Health Products Regulatory Authority
- MDA: Medical Device Authority
- MCC: Medicines Control Council
- FDA: Food and Drug Administration