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.
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.
ANVISA
Globalization and the rapid advance of new technologies have presented a major challenge to regulators worldwide. Highly complex regulatory developments and the globalized production chain have advanced much faster than the availability of financial and human resources in most regulatory authorities.
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