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 new article describes in detail different types of personalised medical devices and highlights the key points.
ANVISA
The new article provides further clarifications on the applicable regulatory requirements, paying special attention to the most important aspects.
ANVISA
The new article highlights certain specific aspects related to the regulatory status of personalised devices allowed for marketing and use in Brazil.
ANVISA
The new article covers the matters related to classification of personalised devices and provides additional clarifications in this respect.
Gartner® Market Guide for Life Science Regulatory Information Management Solutions
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