Brazil ANVISA Medical Device Registration Service
Support for medical-device market access in Brazil across Class I–IV pathways, including classification, local compliance evidence and ANVISA submission coordination. Requirements are scoped according to device class and applicable certification or quality-system obligations.
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Service Overview
EXIMIO can support manufacturers preparing medical devices for the Brazilian market by organizing product classification, required local certifications, quality-system evidence, technical documentation and ANVISA submission steps. The original source uses one combined workflow because the core process branches mainly by device risk class.
Process Flow & Timing
Select a route below to view the workflow and timing.
Class I–IV Registration
Indicative source timing~90-day certification branch; total variesSource estimate; not statutory
ANVISA Registration
Product Classification
Class I
Class II
Class III
Class IV
BGMP Exemption / Applicability
Technical Documentation
Brazil Authorized Representative
INMETRO Certification
BGMP Certification
Technical Documentation
Brazil Authorized Representative
INMETRO Certification
BGMP Certification
Technical Documentation
Brazil Authorized Representative
BGMP / INMETRO as Applicable
Clinical Evidence / Trial as Applicable
Brazil Authorized Representative
Submit ANVISA Application
Registration Approval
Regulatory Basis & Official References
Legal and regulatory references below link directly to the relevant government regulator, official legislation database or official legal text. The applicable provisions should still be confirmed against the device classification, intended purpose and market-access route at project start.
LawANVISA RDC No. 751/2022Risk classification, notification and marketing-authorization rules for medical devices.Open official source ↗LawANVISA RDC No. 830/2023Risk classification, notification and marketing-authorization rules for in vitro diagnostic medical devices.Open official source ↗Official GuidanceANVISA Medical DevicesCurrent ANVISA medical-device regulatory overview and applicable RDC references.Open official source ↗
Related Regulatory Support
Product classification, INMETRO-related coordination, quality-system documentation and Brazilian local-holder support can be included depending on device type.
EXIMIO Support
Contact EXIMIO BIOTEC for pathway confirmation, document-gap review, submission planning, technical-document preparation, authority communication support and a project-specific quotation.