Gain market access in Brazil with ANVISA approval

Electro-medical device product certification in Brazil

Brazil flagBrazil is one of the most interesting new export markets for medical device manufacturers in North America, Europe and Asia. As one the BRIC economies (Brazil, Russia, India and China) it represents significant market growth opportunities.

In surveys, over the last three years, Brazil has been consistently identified by medical device manufacturers as a top new market to consider for their medical devices.

Brazilian Medical Device Regulations

All medical devices in Brazil are regulated by the Brazilian Health Surveillance Agency (ANVISA). ANVISA requires that all devices must complete a device registration process. Non-Brazilian manufacturers need a local Brazilian Registration Holder (BRH) based in Brazil to submit technical files to ANVISA. 

The Brazilian Regulation uses a risk-based classification system to classify devices into one of four groups: Class I (low risk) to Class IV (high risk). In addition, all of your manufacturing locations must comply with Brazilian GMP requirements (RESOLUÇÃO DA DIRETORIA COLEGIADA - RDC N°16, Brazilian regulations similar to ISO 13485).

Brazil and the Medical Device Single Audit Program (MDSAP)

The Medical Device Single Audit Program (MDSAP) allows manufacturers to undergo a single audit to meet the QMS/GMP requirements of multiple Regulatory Authorities (RAs).

The Australian Therapeutic Goods Administration (TGA) is a participating RA, having completed the three year pilot phase of the Program, which ended in December 2016. The TGA will use an MDSAP audit report as part of the evidence that is assessed for compliance with medical device market authorization requirements unless the medical device is otherwise excluded or exempt from these requirements or if current policies restrict the use of MDSAP audit reports.

MDSAP audits are conducted by recognized Auditing Organizations (AOs); BSI is a recognized AO and participated in the Program's pilot phase.

Find out more about the Program, who is involved and BSI's role now.

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Why choose BSI for market access in Brazil?

  • Robust, reliable service consistent with other BSI Medical Devices services (CE and ISO 13485)
  • Knowledgeable product and certification local experts within BSI Brazil
  • Single point of contact with a BSI local account manager for quotations and managing applications
  • Possibility to roll / combine annual INMETRO Product Certification audits into regular ISO 13485 / CE Marking audits
  • Efficient / timely BSI Brazil certification
  • Global recognition and confidence in BSI provides confidence in the manufacturer and their device
  • Accredited MDSAP Auditing Organization (AO) and accredited INMETRO Product Certification Body