Let’s Talk About Regulatory Requirements for Medical Devices in Brazil
Have you ever wondered who regulates medical devices in Brazil or how to submit one for approval?
While studying Medical Technology, one of my courses—Global MedTech—covered how the medical device market operates around the world and the key requirements for bringing products to market in different countries.
During that class, I noticed how challenging it was for my instructor to clearly explain the regulatory pathway in Brazil—mainly due to the lack of reliable sources available in English.
That experience motivated me to dive deeper into Brazil’s medical device regulations and break them down for you here in English. My goal is to make this complex topic easier to understand for global professionals, students, and anyone interested in entering the Brazilian MedTech market.
REGULATORY AUTHORITY IN BRAZIL
The Main Regulatory Authority in Brazil is ANVISA.
English: Brazilian Health Regulatory Agency
ANVISA is the national agency responsible for regulating the registration, manufacturing, importation, commercialisation, and post-market surveillance of medical devices in Brazil.
Key responsibilities of ANVISA regarding medical devices:
•Device classification and registration
•Pre-market approval and licensing
•Inspection of manufacturing and import facilities
•Post-market surveillance (vigilância pós-comercialização)
•Enforcement of Good Manufacturing Practices (GMP) — known locally as Boas Práticas de Fabricação (BPF)
ADDITIONAL AUTHORITIES
While ANVISA is the main body, the following organizations may also be involved and they are called Additional Authorities. It is important to get what they stand out to your medical device to be marketed
1. INMETRO (Instituto Nacional de Metrologia, Qualidade e Tecnologia)
Role: Technical and safety certification for certain device categories.
Importance:
•Required for electromedical and electrical medical equipment (e.g., infusion pumps, ECGs, X-ray machines).
•Ensures devices comply with Brazilian electrical safety and performance standards.
•INMETRO certification is mandatory before ANVISA approval for certain product types.
•Products must carry the INMETRO seal, which confirms conformity to Brazilian technical norms.
2. Customs / Receita Federal (Brazilian Federal Revenue Service)
Role: Oversees customs clearance and tax regulation for imported goods.
Importance:
•Controls the importation of medical devices into Brazil.
•Works in tandem with ANVISA at ports and airports to release or detain shipments.
•Verifies proper documentation, including ANVISA registration, INMETRO certification (if applicable), and import licenses.
•Ensures that import taxes and duties are correctly calculated and paid.
•Any issues at customs can cause significant delays or rejections of device shipments.
3. Ministério da Saúde
(Ministry of Health)
Role: National authority on public health policy and healthcare system regulation.
Importance:
•Sets public health priorities that can influence:
•Which technologies are fast-tracked or prioritized
•Funding decisions through the public health system (SUS)
•Reimbursement policies
•May impact market demand if the device is used in public hospitals or health programs.
•Coordinates with ANVISA on broader health surveillance and strategy for medical technologies.
These entities don’t replace ANVISA but work alongside it to ensure medical devices are safe, effective, legally imported, and aligned with Brazil’s public health goals.
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