ANVISA Updates Rules for Importing Medical Device Components

New ANVISA rules for importing medical device components published in 2024.

QR Group explains regulatory impacts and guides companies on how to maintain compliance safely ANVISA has published a new technical statement on the regulatory framework for medical device components, bringing important clarifications for manufacturers, importers and distributors. The update reinforces the need to evaluate, on a case-by-case basis, the destination and risk of the components, […]