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Focus On Regulation

Insights, analysis, and news about regulatory issues affecting a broad array of industries.

Blog Post

New UK-Wide Model Clinical Trial Agreements Published

13 March 18

An updated Model Clinical Trial Agreement (mCTA) has been published for industry-sponsored clinical trials involving patients in National Health Service (NHS) or Health and Social Care...

Blog Post

CFDA Continues to Expand Oversea Inspection

08 March 18

On Feb 27th, China Food and Drug Administration (CFDA) published their inspection reports for eight international medical device manufacturers located in U.S., Europe, Japan, and...

Blog Post

The HPRA published a MDR/IVDR Guide for Distributors of Medical Devices

28 February 18

The Irish Health Products Regulatory Authority (HPRA) has published a Guide for Distributors of Medical Devices (“Guide”) in which the HPRA provides useful recommendations...

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