ORBIS Compliance

ANVISA Adds DQS and DEKRA to Medical Device Inspection List

Published /Brazil

ANVISA Update

The German organizations DQS Medizinprodukte GmbH and DEKRA Certification B.V. of The Netherlands have been officially added by ANVISA to the list of accredited inspectors for the Medical Device Single Audit Program (MDSAP).

These organizations are now authorized to perform Brazilian Good Manufacturing Practice (BGMP) medical device quality system inspections recognized by ANVISA and other MDSAP participating regulators until December 31, 2018.

This implementation was stated in January of 2017.

For more information, visit ANVISA Announcement - http://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=25/01/2017&jornal=1&page=35&totalArquivos=112.

Brazil Quick Facts

Regulatory AgencyANATEL (Agência Nacional de Telecomunicações)
Certification TypeMandatory
License ValidityTechnical compliance certificate: 2 to 3 years
Application LanguagePortuguese
Legal License HolderRequired
In-country Testing RequirementRequires testing

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