Medical Device Regulation Resources
Worldwide, medical devices are subject to strict regulations, and for good reason — they are crucial for helping health care professionals identify, treat and combat diseases. Strict rules ensure patient safety and treatment efficacy. However, compliance is...
United States
Medical devices are highly regulated in the United States. Since U.S. regulatory compliance for MedTech is stringent and continuously changing, staying up-to-date on the latest standards helps businesses avoid costly violations and improve the efficacy and safety of...
Australia
The article provides an overview of a checklist outlining the main principles to be considered with respect to medical devices intended to be marketed and used in Australia.
Great Britain
The new article elaborates further on special considerations associated with clinical investigations involving medical devices intended to be marketed and used in the UK, highlighting the most important aspects.
Great Britain
The new article describes in detail the approach to be followed when deciding whether clinical investigations are necessary and also elaborates more on the circumstances associated thereto.
Great Britain
The article provides a general overview of the UK regulatory framework for clinical investigations related to medical devices intended to be marketed and used in the country.
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