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Brazil issues new registration guidance:

This article was originally published in Clinica

Executive Summary

The Brazilian health surveillance agency, Anvisa, has issued draft guidance on the registration of electromedical devices, as applicable under resolution 444/99. The guidance, available from the device industry association, ABIMO, clarifies the responsibilities of Brazil's certification department, device manufacturers and importers. Anvisa recently published a new device registration protocol, which reflects Mercosur-wide policy, reports ABIMO. It will be implemented under resolution 185 of October 24 2001, replacing decree 01/96.





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