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Brazil is the largest medical device market in Latin America — and the most structurally complex in this series. It requires two independent certifications that must both be complete before a device can be legally sold. ANVISA handles the health surveillance authorisation. INMETRO handles electrical safety certification for electromedical devices. Neither substitutes for the other, and a supplier who has completed only one of the two has not finished the Brazilian process. For devices with wireless connectivity, there is a third: ANATEL. This guide covers how to verify all three.
RedVance manufactures red light therapy panels in Shenzhen. Brazil is a market that requires careful preparation and local representation, and this guide exists to help buyers ask the right questions before committing. Part of a market-by-market series indexed in our regulatory verification hub.
Three tracks, not one
| Requirement | Agency | What it covers | Applies to |
|---|---|---|---|
| ANVISA registration or notification | ANVISA | Health surveillance authorisation to market the device | All medical devices |
| INMETRO certification | INMETRO-accredited certification body | Electrical safety — prerequisite for ANVISA for applicable devices | Electromedical and electrical devices |
| ANATEL certification | ANATEL-designated certification body | Wireless radiofrequency compliance | Devices with Bluetooth, WiFi or other wireless |
A red light panel is an electrical device. If it makes medical or health claims in Brazil, it is likely subject to both ANVISA and INMETRO requirements. If it has Bluetooth — including app-controlled panels — it also needs ANATEL. Each track is a separate process with a separate certificate. The supplier claiming “we have ANVISA” without a corresponding INMETRO certificate for an electrical device has not answered the full question.
Verifying ANVISA status
ANVISA maintains a public Consulta system where device registrations and notifications can be searched. Ask the supplier for the ANVISA registration or notification number and the Brazil Registration Holder name, then search the Consulta to confirm:
- Status is active — not cancelled, expired or suspended.
- The BRH name matches what the supplier told you.
- The device description matches the product you are buying.
- The intended use on the record corresponds to the claims the supplier intends to make.
Verifying INMETRO certification
INMETRO does not conduct certification itself — it accredits certification bodies (OCPs, Organismos de Certificação de Produto) that carry out the conformity assessment. The technical basis for electromedical equipment is Brazil’s adoption of IEC 60601 standards.
Three things to verify:
- The certificate exists and is current. Ask for the INMETRO certificate number and the name of the issuing OCP. Certified products carry an INMETRO mark on the product and packaging.
- The certificate names the exact model you are buying. This is the most common gap — what specialists describe as the model-number trap.
- The issuing OCP is INMETRO-accredited. Major accredited bodies include internationally recognised names operating in Brazil; a supplier should be able to name the specific OCP.
Foreign IEC 60601 test reports from ILAC-accredited laboratories are generally accepted by INMETRO-accredited OCPs, which means a device that already has IEC 60601 testing from a recognised lab has a faster path to INMETRO certification than one starting from scratch.
ANATEL: the wireless requirement
Any device incorporating wireless communication — Bluetooth, WiFi, RFID or other radiofrequency technology — requires ANATEL certification from Brazil’s National Telecommunications Agency before ANVISA can grant market authorisation.
This is a third independent requirement that sourcing buyers with app-controlled or smart panels often discover late. The certification must be performed by an ANATEL-designated certification body using Brazil-accredited laboratories. If a supplier is providing an app-controlled red light panel for the Brazilian market and cannot produce an ANATEL certificate, that is a gap in their compliance picture — covered in our smart panel guide.
ANVISA’s class structure and what it means for verification
Brazil classifies devices into four risk classes, with two different regulatory tracks:
- Class I and II: Notification (simpler process, shorter timeline).
- Class III and IV: Registration — requires Brazilian Good Manufacturing Practices (B-GMP) inspection or MDSAP equivalence, which adds significant timeline and cost.
A supplier claiming a registration for a Class III or IV device should be able to explain whether they hold an MDSAP certificate or have been through a direct ANVISA inspection. The MDSAP path is generally faster; direct ANVISA inspection has historically involved significant waiting periods. If the supplier has not addressed this question for a higher-class device, it is worth asking before assuming a registration is imminent.
The Brazil verification checklist
- Established whether the product is a medical device under Brazil’s framework given the intended claims.
- Obtained the ANVISA registration or notification number and the BRH name.
- Searched ANVISA’s Consulta and confirmed active status, BRH name and device description.
- For an electrical device: obtained the INMETRO certificate number and issuing OCP name.
- Confirmed the INMETRO certificate names the exact model being purchased — not a family or range.
- For a wireless-enabled device: confirmed ANATEL certification exists for the wireless module.
- For Class III or IV: asked whether MDSAP is held or a direct ANVISA inspection has been completed.
- Obtained technical performance documentation independently of regulatory status.
Other markets in this series: USA, EU, UK, Australia, Canada, Singapore, Malaysia and Mexico. Terms are defined in our glossary.
What a manufacturer can do about it: name the BRH and provide the ANVISA number rather than implying registration that is in progress rather than complete, supply the INMETRO certificate and name the issuing OCP, confirm whether the INMETRO certificate covers the exact model being quoted, disclose ANATEL status for wireless-enabled devices, and tell buyers which class applies and what the GMP basis is for Class III and IV. Brazil’s requirements are genuinely complex — a supplier who can answer all of these clearly has real experience with the market.
Frequently asked questions
How do I verify a supplier’s ANVISA claim for a red light device in Brazil?
Ask for the ANVISA registration or notification number and the Brazil Registration Holder name. Search ANVISA’s public Consulta system to confirm the status is active and the device and holder details match. For electrical devices, also ask for the INMETRO certificate number and verify it covers the specific model you are buying — not a related model in the same range.
What is the difference between ANVISA registration and INMETRO certification in Brazil?
They are two separate and parallel requirements. ANVISA registration is the health surveillance authorisation required to market a medical device in Brazil. INMETRO certification is an electrical safety certification required for electromedical devices before ANVISA registration can be obtained. Both must be complete before a device can be legally sold, and a supplier with only one of the two has not completed the Brazilian process.
What is a Brazil Registration Holder?
A Brazil Registration Holder, or BRH, is the Brazilian company that holds the ANVISA registration on behalf of a foreign manufacturer. Foreign manufacturers without a physical presence in Brazil must appoint one. The BRH submits the application, holds the registration, and is the legal responsible party in Brazil. The ANVISA record will show the BRH name, not the overseas factory.
What is the INMETRO model-number trap?
INMETRO certification covers the specific device model tested, not a product family. A supplier who obtained certification for one model variant and assumes it covers related models is wrong, and ANVISA and customs check the specific model number on the certificate. Always ask the supplier to confirm the INMETRO certificate names the exact SKU you intend to import.
Does a red light panel with Bluetooth need additional certification in Brazil?
Yes. Devices incorporating wireless technologies such as Bluetooth or WiFi require ANATEL certification from Brazil’s National Telecommunications Agency, in addition to ANVISA registration and INMETRO certification. This is a third independent requirement and must be completed before ANVISA grants market authorisation for the device.
Is Brazil’s ANVISA database searchable by the public?
Yes. ANVISA maintains a public Consulta system where device registrations and notifications can be searched. A supplier claiming ANVISA registration who cannot provide a number that returns an active result in the Consulta has not substantiated the claim.
Ask what Brazil requires for this device
Tell us the device configuration and the claims you intend to make in Brazil and we will tell you which of the three tracks apply, what documentation exists, and where the process begins for your brand. Brazil is genuinely complex — the honest answer sometimes includes a timeline, not just a certificate number.
Ask about Brazil documentation →