INMETRO certification: a guide to compliance for foreign businesses
A practical overview of Brazil’s conformity assessment system, which products require the INMETRO mark before they can be sold, and the main compliance obligations that follow.
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INMETRO certification is a technical safety and quality control, separate from ANVISA, and it also requires a Brazilian entity to hold it
The National Institute of Metrology, Quality and Technology (INMETRO) is the federal autarchy responsible for Brazil’s metrology, standardisation and conformity assessment system, created by Law 5,966/1973, which also established CONMETRO as the system’s normative body and SINMETRO as the overall structure.
INMETRO does not test or certify products itself. It accredits the certification bodies (OCPs) and laboratories that do, and maintains the list of product categories subject to compulsory certification. For products in scope, a Brazilian supplier with a CNPJ requests and holds the certification before the product can be placed on the market, and the product must display the INMETRO mark together with the certifying OCP’s own mark.
The regulatory framework
Law 5,966/1973 created SINMETRO, CONMETRO and INMETRO to formulate and execute national policy on metrology, industrial standardisation and quality certification. INMETRO functions as CONMETRO’s executive arm.
Law 9,933/1999 set out CONMETRO’s and INMETRO’s specific competences, including the authority to issue technical regulations and compulsory certification, and the penalty framework for non-compliance.
Beneath these statutes sit INMETRO’s Portarias: specific requirements for each regulated product category. Since 2022, INMETRO has been implementing a new, more risk-based regulatory model, and the practical effect varies by product category, so it must be checked against the current Portaria rather than assumed.
INMETRO does not certify products itself. Certification is carried out by accredited Conformity Assessment Bodies (OCPs), such as TUV SUD, UL Solutions and Nemko, together with accredited testing laboratories. The OCP is the applicant’s day-to-day counterparty throughout the process.
Mandatory and voluntary certification
Some products cannot lawfully be sold without INMETRO certification; others can be sold without it, but certification remains available as a voluntary quality signal.
Scope is decided at the level of INMETRO’s specific product classification. Screening usually starts with the NCM/HS customs code, but the final answer depends on technical characteristics and the exact Portaria scope language; two apparently similar products can sit on different sides of the mandatory line. Confirming scope for the exact product, at the outset, is the single most consequential step in the process.
How INMETRO certification works
Typical timing. For most categories, engaging an OCP, testing, any factory audit and issuance takes roughly 2 to 6 months. Medical devices and other categories requiring a combined quality-system audit often run 5 to 9 months. Plan a launch date with meaningful contingency.
Categories most often subject to INMETRO certification
The list changes. INMETRO periodically adds, removes or updates categories, and a product’s status can move between mandatory, voluntary and unregulated. Check the applicable Portaria against INMETRO’s current published list before finalising a compliance strategy.
Where INMETRO and ANVISA overlap, and where they do not
Foreign businesses frequently assume INMETRO certification and ANVISA registration are alternatives. For many electro-medical and health-adjacent products, both are required, address different questions, and are obtained through different processes.
Where a product requires both, the practical sequence is normally to obtain INMETRO certification before completing ANVISA registration, since ANVISA’s dossier for these products commonly expects the certificate to be in place. Confirm sequencing with both the OCP and the ANVISA regulatory team before committing to a project timeline.
Different certificate holder, potentially different entity. The entity holding INMETRO certification and the entity holding ANVISA registration do not have to be the same company. Where different entities are used, document the interface between the two processes clearly.
Practical steps: certifying a product for the Brazilian market
Key risks and practical points
Need advice on your INMETRO compliance strategy?
The right certification pathway, sequencing with any ANVISA requirement, and choice of local representative depend heavily on the specific product involved.
This guide provides general information on INMETRO certification and compliance as at the date of publication. It does not constitute legal advice and should not be relied upon as such. INMETRO’s Portarias are revised frequently; always verify the current framework applicable to a specific product with a qualified Brazilian lawyer, an accredited Conformity Assessment Body, or INMETRO directly before acting.
Brazilian lawyers for foreign companies, investors and law firms.