When a manufacturer brings me an FDA-cleared or CE-marked powered device for Brazil, the timeline conversation usually starts with ANVISA. It should start one step earlier. For electromedical equipment, ANVISA won’t grant, change or revalidate the registration without a Brazilian conformity certificate, and a device with a radio inside needs a separate ANATEL homologation before it can be sold. Neither is replaced by your CB report, your 510(k) or your CE certificate.
I am Julio Martinez-Clark, CEO of bioaccess®. This page explains the two certifications that sit in front of many ANVISA device files: compulsory conformity certification under RDC 549/2021, usually called “INMETRO certification”, and ANATEL homologation under Resolução 715/2019. It sits alongside our Brazil ANVISA registration page, the Brazil registration holder guide and the LATAM market-access hub. This is operator guidance, not legal advice.
One-sentence answer
Under ANVISA RDC 549 of 30 August 2021, medical, dental, laboratory, physiotherapy and aesthetic equipment must carry a conformity certificate issued within the Brazilian conformity assessment system (SBAC) by an Inmetro-accredited certification body established in Brazil, against the standards listed in ANVISA IN 283/2024, and the supplier must present it to grant, change or revalidate the ANVISA registration or notification. Any telecom function needs ANATEL homologation, which Resolução 715/2019 Art. 55 makes a mandatory prerequisite for use and sale in Brazil.
Which devices need the conformity certificate
RDC 549/2021 (in force since 1 October 2021) covers “equipment under health surveillance”, including parts and accessories. Article 2 §2 defines two groups:
- equipment with a medical, dental, laboratory or physiotherapy purpose, used directly or indirectly for diagnosis, treatment, rehabilitation or monitoring in humans;
- equipment for beautification and aesthetics.
The test is whether the product is equipment within the field of application of a listed standard, not its risk class. Article 3 applies to both registration (registro) and notification files. So a Class II notified device can need the certificate just as a Class III registered one does. Article 2 §3 also says the certificate isn’t the only proof of safety and efficacy, and ANVISA can still ask for more studies.
Which standards apply: IN 283/2024
RDC 549 points to a list of technical standards set by ANVISA instruction. The current list is Instrução Normativa 283 of 7 March 2024, in force from 1 April 2024, which revoked IN 116/2021. Annex I lists the ABNT NBR IEC 60601 family: the general standard 60601-1, collaterals such as 60601-1-2 (electromagnetic disturbances), 60601-1-6 (usability) and 60601-1-8 (alarm systems), and the particular standards for specific equipment types.
Annex II sets a transition worth putting on your calendar. ABNT NBR IEC 60601-1:2010 with Amendment 1:2016 is the version currently enforced. The version with Amendment 2:2022 becomes compulsory on 31 December 2027, and 60601-1-2 with Amendment 1:2022 follows the same date. If your test reports predate Amendment 2, ask your certification body now whether a renewal or change filing after that date will need new testing.
Two other IN 283 provisions help in practice. Article 2: when no accredited Brazilian lab can run part of a standard, the certification body justifies the gap and lists the exclusions on the certificate. Article 3: if ANVISA asks you to add a standard that you believe doesn’t apply, you answer with a technical justification, which you may have a certification body issue.
Who issues the certificate
Inmetro’s FAQ (updated 7 April 2026) states that the certification is performed by a product certification body (OCP) established in Brazil and accredited by Inmetro, under Portaria Inmetro 384 of 18 December 2020 as amended by Portaria 254 of 9 June 2021. That portaria sets the conformity assessment requirements and the identification seal. Two details in the portaria are worth knowing:
- Article 2 says Inmetro doesn’t regulate these products technically. ANVISA sets the requirements; Inmetro accredits the bodies that check them.
- Article 6-A lets the certificate expire early if the certification body or ANVISA finds the manufacturer changed the design in a way that critically affects safety.
The OCP runs the evaluation its certification scheme sets out. Pick it early and agree with it which of your existing reports it can accept.
What the certificate does in the ANVISA file
- Grant, change and revalidation (RDC 549 Art. 3). The supplier presents a copy of the certificate. Changes that count are those that affect the standards used in the certification, and the certification body that issued the certificate assesses that impact.
- A shortcut for imports (Art. 3 §1). An importer filing a certified imported device is exempt from presenting the certificate of free sale or origin-country registration. That is useful for devices whose home approval is still pending, a problem I covered in the certificate of free sale trap.
- Summary rejection (RDC 751/2022 Art. 10 §4). Under ANVISA’s device registration rule, a petition missing a required conformity certificate isn’t sent a deficiency letter; it can be refused outright.
- Suspension (RDC 751/2022 Art. 39). ANVISA can suspend manufacture, import, distribution, sale and use when a compulsory conformity certificate is missing.
When certification isn’t possible
RDC 549 Article 4 covers equipment that can’t be certified in the SBAC at the time of filing. The applicant presents a declaration from an Inmetro-accredited certification body explaining why. Once capacity exists, the holder has 180 days to present the certificate, and missing that window starts suspension and cancellation. Where the problem is partial and temporary, the file instead carries a consolidated report from an OCP, in Portuguese and showing conformity on every item checked. For equipment tested abroad, the OCP can build that report on test reports from labs accredited by ILAC signatories, as long as they cover at least the items that can be tested in Brazil.
Keeping it valid
Article 7 makes the certificate a condition for keeping the registration. If it is canceled or expires during the registration’s life, you have 90 days to present a new one; past that, suspension and cancellation procedures start. The 90 days don’t apply if the certificate was pulled because the product failed the standards. Put certificate expiry and surveillance audits in the same tracker as the ANVISA revalidation.
ANATEL: the radio is a separate product
If the device has Bluetooth, Wi-Fi, cellular or another radio, a second regime applies. ANATEL’s Resolução 715 of 23 October 2019 defines a telecommunications product as equipment, apparatus, device or element that is necessary or sufficient to carry out telecommunications, including accessories and peripherals (Art. 4, XVI). Article 55 makes homologation a mandatory prerequisite for using and selling such products in Brazil. Since Resolução 780 of 1 August 2025, Article 55 §1 also lets ANATEL require homologation before import in cases it defines by operational procedure.
The certificate comes from a designated certification body that the applicant chooses (Art. 40), and the applicant has to show it can meet Brazilian consumer guarantees, including product information, warranty and technical assistance (Art. 21). ANATEL homologation and the RDC 549 certificate are separate procedures under separate agencies. Plan both, and decide early which Brazilian company applies for each one.
How bioaccess® handles it
bioaccess® acts as your Brazil Registration Holder through our own Brazilian entity and files the ANVISA dossier. Before filing, we map which IN 283 standards apply, collect your existing test reports, coordinate the Brazilian OCP and any ANATEL designated certification body, and line up the certificates with the registration timeline. As the Brazil page states, INMETRO and ANATEL work is not included in the registration and holder fees and is quoted separately, as is Brazil GMP. Brazil pricing is two-part: a one-time registration fee plus an annual holder fee. If you are planning a clinical study rather than a launch, start with clinical trials in Brazil.
Operator checklist
- Check whether your device is equipment within the field of a standard in IN 283/2024 Annex I, whatever its risk class.
- Choose an Inmetro-accredited OCP established in Brazil and agree which existing reports it accepts.
- Check your 60601-1 and 60601-1-2 reports against the 31 December 2027 Annex II date.
- If certification isn’t possible, get the Article 4 OCP declaration and track the 180-day clock.
- Identify every radio function and plan ANATEL homologation before import and sale.
- Track certificate expiry with the 90-day replacement window in Article 7.
- Have the certification body assess design changes before you file a registration change.