ANVISA Q&A on Personalised Devices: Overview
The article provides a brief overview of the regulatory requirements applicable to personalised medical devices intended to be marketed and used in Brazil.
The article provides a brief overview of the regulatory requirements applicable to personalised medical devices intended to be marketed and used in Brazil.
The new article describes in detail different types of personalised medical devices and highlights the key points.
The new article provides further clarifications on the applicable regulatory requirements, paying special attention to the most important aspects.
The new article highlights certain specific aspects related to the regulatory status of personalised devices allowed for marketing and use in Brazil.
The new article covers the matters related to classification of personalised devices and provides additional clarifications in this respect.
RegDesk is recognized as a Regulatory Intelligence Representative Vendor! Learn more by reading the 2024 Gartner® Market Guide for Regulatory Intelligence Solutions.
Get the report