Gain market access in Brazil with ANVISA approval

Brazilian Medical Device Regulations

Brazilian Medical Device Regulations

Brazil 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.

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)

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

ANVISA utilizes the outcomes of the program, including the reports, to constitute an important input on ANVISA’s pre-market and postmarket assessment procedures. It provides, when applicable, key information that is expected to support regulatory technical evaluation on these issues.

MDSAP Audits are conducted by Auditing Organizations (AO), such as BSI, which are authorized by the participating RA to audit under MDSAP requirements. MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States.

A BSI MDSAP audit can also be combined with assessment for CE and ISO 13485.

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Why choose BSI for market access in Brazil?

  • Accredited MDSAP Auditing Organization (AO)
  • Reliable service consistent with other BSI Medical Devices services (CE, ISO 13485 and MDSAP)
  • Knowledgeable product and regulatory experts within BSI Brazil
  • Single point of contact with a BSI local account manager for quotations and managing applications
  • Robust BSI Brazil certification
  • Global recognition and confidence in BSI provides confidence in the manufacturer and their device

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