INMETRO Certification For Medical Devices In Brazil
INMETRO certification is not a blanket certificate for every medical device. In Brazil, ANVISA determines when equipment subject to health surveillance must undergo conformity assessment under RDC 549/2021; an INMETRO-accredited Product Certification Body (OCP) evaluates it using Ordinance 384/2020, as amended. Before ordering tests, verify the device’s intended use, applicable standards and exact model scope.
Is certification required for this model?
Apply two separate tests: (1) identify the device and its ANVISA pathway; (2) check whether RDC 549/2021 and the applicable scope of IN 283/2024 require an SBAC certificate. ANVISA risk class by itself does not decide the second test.
| Product situation | Safe certification decision |
|---|---|
| Electromedical diagnostic or therapeutic equipment | Screen IEC 60601/80601 general, collateral and particular standards against the intended use; obtain the OCP’s model-specific scope decision. |
| Non-electrical equipment, furniture or mobility products | Do not assume exemption: IN 283/2024 also lists product standards beyond IEC 60601, including selected wheelchair and dental equipment standards. |
| IVD kit, standalone software or accessory | Do not transfer the parent device’s decision automatically. Determine the product category, intended use and whether a listed standard covers the specific item. |
| Multiple models, accessories or changed configuration | Map tested models, power supplies, software versions and accessories against the proposed certificate; differences may require extra assessment. |
Map the standards and transition dates
IN 283/2024 took effect on 1 April 2024 and revoked IN 116/2021. Its Annex I identifies applicable standards; Annex II sets mandatory adoption dates for specified versions. A newer published edition is not automatically the edition already mandatory for every device.
| Control point | What to verify |
|---|---|
| General safety | For devices within scope, map ABNT NBR IEC 60601-1 and its amendments. Annex II sets 31 December 2027 for the listed Amendment 2:2022 combination. |
| EMC and collateral requirements | Assess applicable IEC 60601 collateral standards; Annex II also sets 31 December 2027 for the listed IEC 60601-1-2 Amendment 1:2022 combination. |
| Particular product standard | Identify the exact 60601-2 / 80601-2 or other listed standard, version and Annex II date for the device. Do not apply one deadline to all products. |
Under IN 283/2024 Article 4, a replacement edition may be used before it becomes compulsory, but a cancelled listed edition remains required until the IN is revised. The Annex II dates differ materially: several collateral updates became mandatory on 31 December 2025; ABNT NBR ISO 80601-2-61:2022 (pulse oximetry) is scheduled for 31 December 2026; the two general/EMC amendments noted above are scheduled for 31 December 2027. Check the applicable line, not a single universal transition date.
Some INMETRO FAQ pages still refer to superseded IN 116/2021. For the mandatory-standards list, use ANVISA’s current IN 283/2024 and its official regulatory index instead.
Prepare the evidence for the OCP
Send the OCP one traceable model-and-evidence pack before commissioning new testing:
- Intended use, product category, risk-class rationale and Brazilian applicant/contact.
- Model/family list, drawings, ratings, configurations, power supplies and accessories.
- Standards applicability matrix with exact editions, including written technical reasons for non-applicability.
- Accredited laboratory reports with scope, dates, tested versions, deviations and unresolved gaps; overseas IEC reports are evidence for OCP review, not an automatic Brazilian certificate.
- Risk and essential-performance files, manuals/labels, manufacturing/QMS evidence and proposed change-control owner.
If ANVISA asks for a standard to be added to an already-submitted certificate and the applicant considers it inapplicable, IN 283/2024 Article 3 calls for a reasoned technical non-applicability document grounded in the standard’s scope and requirements. The applicant may use an OCP to prepare it, but the provision does not make OCP authorship mandatory.
Handle gaps, exceptions and changes
Distinguish three cases. First, under IN 283/2024 Article 2, a lack of accredited laboratory capacity in Brazil must be justified by the OCP; exclusions in partial certification must be recorded, and missing capacity must be rechecked at subsequent certificate maintenance. Second, when SBAC certification cannot be issued, RDC 549/2021 Article 4 §1 requires an accredited OCP’s reasoned declaration. If the impediment is temporary and partial, Article 4 §§4–9 instead sets requirements for an OCP-issued consolidated report, based on accredited laboratories, with conformity for every assessed item and a report in Portuguese. For overseas test reports used in that consolidated-report route, the relevant accreditation must come from an ILAC-signatory body and the specified Brazilian-testable coverage must be met. Neither case is a manufacturer-issued exemption.
Two follow-up clocks must not be confused: where ANVISA granted or maintained a notification/registration without a certificate under RDC 549/2021 Article 4, §2 requires the certificate within 180 days after SBAC certification capacity is restored, with suspension/cancellation proceedings for failure. Separately, under Article 7, loss or expiry of an existing certificate generally allows 90 days to submit a new one; the 90-day grace route does not apply where suspension or cancellation stems from failure to meet the applicable technical standards. Ask the OCP and ANVISA to confirm the applicable factual trigger before distribution.
Next actions and regulatory hand-offs
A decision-ready sequence is:
- Freeze intended use and model/accessory scope; classify the ANVISA device separately.
- Build an IN 283/2024 applicability and edition-date matrix; flag disputed exclusions.
- Ask an INMETRO-accredited OCP to confirm scope, report acceptability, testing gaps and certificate route in writing.
- Align certification evidence with the ANVISA notification/registration submission; do not treat a certificate as marketing authorization.
For the filing steps, consult medical-device registration in Brazil; for laboratory planning, INMETRO testing services; for product-specific wireless/wearable overlaps, Brazilian wearable-device compliance. This page owns the decision whether and how this medical-device model needs INMETRO conformity assessment.
Official sources
Questions manufacturers actually ask
Does an EU CE mark or IEC 60601 report replace Brazilian certification?
No. Existing reports may reduce duplicate testing if the OCP accepts their scope and accreditation; the Brazilian conformity decision and any ANVISA submission remain separate.
Can a Class I or II device require an INMETRO certificate?
Yes. ANVISA notification versus registration is a different decision from mandatory equipment certification; check the listed standards and intended use.
Are non-electrical devices automatically outside INMETRO?
No. The IN 283/2024 list includes some non-60601 standards. An IVD reagent or software item likewise needs its own documented scope review, not an assumption.
What if a mandatory test cannot be performed in Brazil?
Ask the OCP to document laboratory availability and evaluate the limited IN 283/2024 and RDC 549/2021 mechanisms; exceptions are conditional, not self-declared.
Can one certificate cover new accessories or software revisions?
Only to the extent the OCP confirms the covered model/configuration and change impact. Check the certificate, tested evidence and ANVISA change obligations before distribution.