Brazil market access

Brazil market access

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

In independent surveys, over the last few 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), medical devices are classified according to their risk, Class I (low risk) to Class IV (high risk). Non-Brazilian manufacturers also need a local Brazilian Registration Holder (BRH) based in Brazil.

ANVISA requires that all devices must complete a device registration process, this includes submitting a technical file to ANVISA through the BRH and all manufacturing locations need to comply with Brazilian GMP (RESOLUÇÃO DA DIRETORIA COLEGIADA - RDC N°16, Brazilian regulations similar to ISO 13485).

BSI is working towards qualification to conduct Brazilian GMP inspections as a third party Auditing Organization (AO) under the Medical Device Single Audit Program (MDSAP) initiative. ANVISA conducts the technical file review and issues the registration.

Electro-Medical Devices IEC 60601 and INMETRO

Before electro-medical ‘active’ medical devices can be submitted to ANVISA for registration and market clearance INMETRO IEC 60601 Product Certification must be obtained.

IEC 60601 is the international standard for safety of electro-medical devices. BSI Brazil is an accredited INMETRO IEC 60601 Product Certification Body and can issued the mandatory product certification.

As with ANVISA registration, electro-medical device manufacturers must have a local representative who applies for the product certification. Medical devices must be tested to IEC 60601, all the relevant parts of the standard, manufacturers will also be audited by the INMETRO Product Certification Body (BSI Brazil) or their approved agent (some local BSI offices), product certification is issued for up to five years.

* INMETRO is the national accreditation body for testing, certification and system assessment.

How can BSI help you achieve product certification in Brazil?

  • Predictable, reliable service consistent with other BSI Healthcare 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
  • BSI will be conducting MDSAP GMP audits in the future that will be recognized by ANVISA