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 Class I (low risk) to Class IV (high risk). In addition, all of your manufacturing locations must comply with Brazilian GMP (RESOLUÇÃO DA DIRETORIA COLEGIADA - RDC N°16, Brazilian regulations similar to ISO 13485).

BSI will soon qualify to conduct Brazilian GMP inspections 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

IEC 60601 is the international standard for safety of electro-medical devices. Electro-medical devices entering Brazil require a mandatory INMETRO* IEC 60601 product certification, this must be completed before applying for ANVISA registration. BSI Brazil is accredited by INMETRO to issue IEC 60601 Product Certification.

All electro-medical manufacturers must have a local representative that will apply for product certification. Medical devices must be tested to IEC 60601 and the relevant parts of the standard, manufacturers will audited by the INMETRO Product Certification Body or their approved agent, product certification is issued for up to five years.

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

What is BSI's role in market access in Brazil?

  • Robust, 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 audits that will be recognized by ANVISA