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Medtech suppliers get new tool for navigating Brazil’s regulatory maze

This article was originally published in Clinica

Executive Summary

Medical device manufacturers and distributors in Brazil have a new tool for navigating the regulatory maze that is the Brazilian healthcare industry. Medtech regulatory agency Anvisa, together with the national industrial development agency (ABDI) and the national support service for small and medium-sized enterprises (Sebrae) have published a “Compendium of healthcare regulations on medical devices”, with the promise of offering in a single document every regulation affecting the medtech supplies sector. The document (Compêndio da Legislação Sanit�ria de Dispositivos Médicos) was unveiled during the Hospitalar medtech trade fair, which ended last week in São Paulo, and is available via the Anvisa website (www.anvisa.gov.br).

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