INMETRO (National Institute of Metrology, Quality and Technology)

INMETRO (Instituto Nacional de Metrologia, Qualidade e Tecnologia) is Brazil’s National Institute of Metrology, Quality and Technology. It develops and administers conformity-assessment programs, accredits conformity-assessment bodies, and supports national metrology and product-safety policy. For medical devices, INMETRO is an adjacent technical authority: ANVISA, not INMETRO, grants medical device market authorization.

When is INMETRO certification required for a medical device?

Certification applies to specified device categories, particularly certain electrical medical equipment subject to Brazilian conformity-assessment requirements. A typical project includes testing against applicable IEC/ABNT standards through an accredited laboratory, review by an accredited product certification body, and—where the scheme requires it—manufacturing-site assessment and ongoing surveillance.

The exact scope depends on the product, standards, and current implementing rules. Manufacturers should confirm applicability early because certification can be a prerequisite to an ANVISA registration or notification submission.

How does INMETRO relate to ANVISA?

ANVISA regulates medical devices and establishes when conformity certification is required. RDC 549/2021 provides the framework for certification under the Brazilian Conformity Assessment System, while ANVISA's current complementary instruction identifies the devices covered by mandatory certification. As of this review, ANVISA lists Normative Instruction IN 283/2024 for this purpose; applicants should check for later amendments before testing or filing.

See the ANVISA medical device regulations overview and the official INMETRO website for current requirements.

Is INMETRO Brazil's medical device regulator?

No. ANVISA is the health authority responsible for medical device registration and post-market oversight. INMETRO manages conformity-assessment infrastructure and certification for product categories within its scope. A device can therefore need both ANVISA authorization and INMETRO certification, but the two decisions address different requirements. See the Brazil market guide for the complete pathway.