ORBIS Compliance

Brazil Achieves OECD Acceptance for Medical Device Testing

Published /Brazil

OECD Acceptance Benefits Brazil's Economy

The acceptance of Brazilian medical device tests by the Organization for Economic Cooperation and Development (OECD) brings significant benefits to Brazil's economy and international trade. Under this mutual acceptance of laboratory data (MAD), the OECD recognizes tests conducted in Brazilian facilities compliant with Good Laboratory Practice (GLP) principles. This recognition reduces trade barriers, increases confidence in imports and exports, eliminates duplicative testing, minimizes animal testing, saves time and costs, and promotes harmonization in regulatory processes.

Strengthening Brazil's Position in Trade

Brazil's National Institute of Metrology, Quality, and Technology (Inmetro) has 50 GLP-compliant test facilities, strengthening Brazil's position in international trade. The initial agreement between Brazil and the OECD focused on pesticides and industrial chemical substances. Over time, the scope expanded to include various sectors, including veterinary products, cosmetics, pharmaceuticals, and now medical devices.

Commitment to International Standards

This expansion demonstrates Brazil's commitment to international standards and will be significant for Brazil's medical device industry. It strengthens Brazil's position in international trade, promotes economic growth, streamlines regulatory processes, and enhances the competitiveness of Brazilian medical device manufacturers in global markets.

Read more here - https://www.gov.br/inmetro/pt-br/centrais-de-conteudo/noticias/testes-de-dispositivos-medicos-realizados-no-brasil-passam-a-ser-aceitos-na-ocde.

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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