HPRA
The article provides a general overview of the regulatory requirements applicable to medical devices created and manufactured by healthcare institutions to meet their own internal needs.
ANVISA
The article provides a brief overview of the regulatory requirements applicable to personalised medical devices intended to be marketed and used in Brazil.
ANVISA
The new article describes in detail different types of personalised medical devices and highlights the key points.
EU
The article highlights the key points related to the regulatory status of in vitro diagnostic medical devices under the existing legal framework.
ANVISA
The new article provides further clarifications on the applicable regulatory requirements, paying special attention to the most important aspects.
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