The newly published ANVISA manual provides updated guidance for the regularisation of medical devices and in vitro diagnostic products in Brazil. Covering topics such as device classification, documentation, GMP certification, and use of the Solicita system, this manual is essential for medical device and IVD manufacturers looking to expand into Brazil. By ensuring regulatory compliance, manufacturers can achieve faster access to Brazil’s large and growing healthcare market.

The FDA 's recent decision to expand the use of unannounced inspections at manufacturing facilities outside the United States has relevant implications for medical device and drug manufacturers exporting to the US market. This approach requires manufacturers to maintain robust quality systems, permanently updated documentation and a culture of continuous compliance.

The new version of Swissmedic's guidance on GMP compliance verification of foreign manufacturers applies to all marketing authorization (MA) holders and their Responsible Persons (RP) in Switzerland.