Brazilian medtech certification for Grossenbacher

11.11.2020 | Within the context of a medical electronics project with a long-standing internationally operating customer, we were allowed to accompany the certification by the Brazilian Ministry of Health ANVISA.

In order to be able to sell its devices on the Brazilian market, the first inspection by INMETRO followed the basic inspection by the Ministry of Health ANVISA (initial certification). INMETRO will now also audit annually the maintenance of the certificate.

In this context, Grossenbacher understands that, in addition to the quarterly inspections carried out by the notified bodies, the maintenance and further development of the necessary safety test (electrical safety final inspection) on the devices must also be carried out. This is done from both a technical and a documentary point of view.

We are pleased to be able to support our customers in the export of medical devices to Brazil and other countries accepted by ANVISA.

Download: Certificate