INMETRO and ANVISA: Two Brazilian Routes Compared
Brazil splits certification between two authorities. INMETRO is the technical regulator for equipment and electrical products; ANVISA is the health surveillance agency for cosmetics, medical devices and supplements. Both require a local representative and Portuguese documentation.
Two authorities, two remits
Brazil is the largest economy in South America and a strategic market for Italian exports, with active development in industry, healthcare, cosmetics and energy. Brazilian law regulates imports strictly, and without local certification products cannot be marketed.
| Authority | Remit |
|---|---|
| INMETRO, Instituto Nacional de Metrologia, Qualidade e Tecnologia | Technical and industrial standards |
| ANVISA, Agência Nacional de Vigilância Sanitária | Cosmetics, medical devices, pharmaceuticals, health-related products |
INMETRO: equipment and machinery
INMETRO is Brazil’s national technical regulation system, comparable in role to the European CE mark. It certifies that equipment or electrical products meet Brazilian standards of safety, energy efficiency and quality.
Products in scope: electrical and industrial equipment; household appliances; laboratory instruments; automation and energy systems; elevators, pumps, cables and components.
The five stages:
- Appointment of a local representative, mandatory, a Brazilian resident company
- Submission of an application to an accredited certification body (OCP)
- Provision of technical documentation: CE, ISO, drawings, and user manuals in Portuguese
- Product testing in an accredited Brazilian laboratory
- Issuance of the certificate and registration in the national database
Validity: typically 3 years, with annual inspections.
ANVISA: cosmetics and health products
ANVISA is Brazil’s health surveillance agency, controlling the safety, composition and labelling of cosmetics, dermatological products, medical devices, food supplements and pharmaceutical drugs.
The four steps:
- Appointment of a local authorised representative (Legal Representative)
- Submission of a technical dossier, formulations, MSDS, test reports, ISO 22716 (GMP)
- Product evaluation and registration in the ANVISA database
- Issuance of the ANVISA registration number (Registro ANVISA)
Validity: 5 years, renewable.
What do both routes share?
- An authorised local representative in Brazil is mandatory. Neither route has an exception.
- All documents must be in Portuguese.
- ISO and CE certificates facilitate the process but do not replace INMETRO or ANVISA. They shorten the file; they do not remove the requirement.
- Unregistered products may be held at customs or returned.
- Cosmetics must comply with GMP standards, which for ANVISA means ISO 22716.
The third point is the one Italian manufacturers most often misjudge. A full CE technical file is genuinely useful, it is not a substitute, and the testing in step 4 of the INMETRO route happens regardless.
Sources
- INMETRO, Instituto Nacional de Metrologia, Qualidade e Tecnologia
- ANVISA, Agência Nacional de Vigilância Sanitária
- ISO 22716, Cosmetics, Good Manufacturing Practices
Frequently asked questions
Which authority handles which products?
INMETRO covers electrical and industrial equipment, household appliances, laboratory instruments, automation and energy systems, elevators, pumps, cables and components. ANVISA covers cosmetics, dermatological products, medical devices, food supplements and pharmaceutical drugs.
Do CE and ISO certificates replace Brazilian certification?
No. ISO and CE certificates facilitate the process but do not replace INMETRO or ANVISA. Unregistered products may be held at customs or returned, whatever European approvals they carry.
How long is each valid?
An INMETRO certificate typically runs three years with annual inspections. An ANVISA registration runs five years and is renewable. Both require an authorised local representative in Brazil and all documents in Portuguese.
Not sure which of these applies to your product? Send it and we will tell you
Related articles
ANVISA Cosmetic Certification in Brazil: A Route Map
What ANVISA requires before a cosmetic can be sold in Brazil: the four document sets, the three tests, Portuguese labelling rules and the ingredient limits.
INMETRO Certification for German Equipment Makers
The five-step INMETRO route into Brazil for industrial, electrical and laboratory equipment, with realistic timelines and what it buys you in tenders.
Certifying a Wireless Pressure Sensor in Brazil
A device that is both a measuring instrument and a radio transmitter faces two sets of requirements. The four steps, and the three that trip people up.
