Brazil Market Access for Medical Device

REGULATORY AGENCY

• Brazilian National Health Surveillance Agency, Agência Nacional de Vigilância Sanitária (ANVISA)

REGULATIONS

• All medical devices intended for sale in Brazil must be registered with ANVISA. Prior to registration at ANVISA, a BGMP inspection according to RDC 16/2013 at the manufacturing facility has to be performed for manufacturers of Class III and Class IV medical devices.
• For most electrical and some non-electrical medical devices, INMETRO certification is also mandatory in order to achieve registration at ANVISA. Only test reports from certain accredited test laboratories, which are not older than two years from the date of certification, are accepted.
• Products must be marked with the INMETRO Mark.

GUIDELINES

• A local legal representative who is responsible for INMETRO certification and registration at ANVISA is necessary.

The following requirements are described in RDC 185/2001:

• Technical Documentation to be submitted is to a large extent compliant with the Global Harmonisation Task Force Guidance (GHTF) for Summary Technical Documentation (STED). In addition, some further specific documents will be requested.
• Medical device classification bears similarities to the EU Medical Device Directive.

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