Brazil ANVISA Medical Device Registration: BRH, RDC 751/2022, B-GMP and INMETRO

Brazil is the largest medical device market in Latin America, and one of the five regulators in the Medical Device Single Audit Program (MDSAP). For many manufacturers it is the natural next step after the US, EU, Canada and Australia. It is also a market where the practical details decide the schedule: a local legal holder, Portuguese labelling, a Brazilian quality certificate for higher-risk devices and, for some products, separate certifications for electrical safety or radio frequency. This guide explains how the National Health Surveillance Agency (ANVISA) regulates medical devices, how notification differs from registration, and how to plan the critical path.

The regulatory framework

Devices in Brazil are regulated under sanitary surveillance law and ANVISA resolutions (RDCs). The core texts to know are:

• RDC 751/2022: classification, risk-based pathways (notification or registration), labelling and instructions for use for medical devices other than IVDs.
• RDC 830/2023: the corresponding rules for in vitro diagnostic devices.
• RDC 665/2022: good manufacturing practices for medical devices and IVDs, the Brazilian quality system requirements, which are closely based on ISO 13485.
• RDC 591/2021: unique device identification, phased in by class.

ANVISA updates its rules often, and some guidance exists only in Portuguese. Use these resolutions as the starting list and confirm the current versions on the ANVISA website.

Classification and route

Class	Risk	Route	Quality certificate
I	Low	Notification	Not required for filing, but the manufacturer must comply with GMP
II	Medium	Notification	Not required for filing, but the manufacturer must comply with GMP
III	High	Registration	Brazilian GMP certificate normally required
IV	Maximum	Registration	Brazilian GMP certificate normally required

RDC 751/2022 uses 22 classification rules, with similarities to the EU rules but differences in detail. Products that were notified or registered under older rules were reclassified in some cases, and some moved into a higher class, so do not assume that an old class carries over. Our guide to device classification explains how to compare systems before you commit to a plan. A notification does not expire, while a registration is valid for ten years and must be renewed on time.

The Brazil Registration Holder

The BRH is a Brazilian company that holds the notification or registration in its own name, submits the file, communicates with ANVISA, and carries local responsibility for importation, post-market surveillance, adverse event reporting and recalls. In practice it is a distributor or a specialist service provider.

• The registration number appears on the labelling and is tied to the BRH. Changing the BRH later is possible but needs a formal process, so negotiate the contract carefully (document access, change notification, vigilance, termination and transfer).
• The BRH must be able to provide technical documentation and manufacturer information on request. Make sure it has access to a current copy of the technical file.

Good manufacturing practices: the Brazilian GMP certificate

For Class III and IV devices, the manufacturer needs a valid Brazilian GMP certificate (often called B-GMP or CBPF) for the manufacturing site. ANVISA assesses compliance with RDC 665/2022, usually through an inspection of the site or, in some cases, a documentary assessment.

• MDSAP: ANVISA accepts MDSAP audit reports and certificates when the scope includes Brazil and the site and products match. It may then waive its own inspection, though the certificate must still be requested and fees paid.
• Without MDSAP: expect an ANVISA inspection, a longer lead time and travel costs. This is the largest source of schedule risk for a first Brazilian Class III or IV file.
• Certificates have limited validity and need to be renewed in advance. Track the date for each site.

If you do not yet have an MDSAP program, the ISO 13485 and MDSAP audit readiness guide explains how one audit can serve several of the five regulators.

Other certifications that can come first

• INMETRO: electrical medical equipment generally needs certification against Brazilian adoptions of IEC 60601, issued through an accredited body. Start from our IEC 60601 guide, then check the Brazilian national differences. The INMETRO seal appears on the labelling.
• ANATEL: devices with radio-frequency functions such as Bluetooth or Wi-Fi need telecommunications certification.
• INCQS: some IVDs, for example for certain infectious diseases and blood screening, need testing by the national quality control institute before registration.

These are on the critical path: they must be completed before the ANVISA submission, and the certificate numbers often need to be on the label.

Step-by-step for a foreign manufacturer

1. Classify the device under RDC 751/2022 (or RDC 830/2023 for IVDs) and decide between notification and registration.
2. Choose and contract the BRH.
3. Plan the GMP evidence for Class III and IV: MDSAP, or an ANVISA inspection, or the reliance route available for qualifying products.
4. Identify extra certifications (INMETRO, ANATEL, INCQS) and start them early.
5. Prepare the technical dossier. The structure aligns broadly with the IMDRF table of contents, but ANVISA expects specific summaries, risk management, clinical evidence, stability and sterilisation data where relevant. Biological evaluation follows the principles in ISO 10993.
6. Prepare Portuguese labelling and instructions for use. The registration number and the BRH details appear on the label.
7. File through the BRH and pay the registration fee. Respond to ANVISA’s requests for information within the deadline.
8. Launch and maintain. Keep the GMP certificate valid, report adverse events, notify changes and renew the registration on time.

The reliance pathway

Since 2024 ANVISA has offered an optimised review route for Class III and IV devices that already have approval from selected reference regulators. It can shorten the technical review, but it does not remove the need for a BRH, Portuguese labelling, GMP evidence or the other Brazilian certifications. Check the current list of accepted regulators and the eligibility rules before you plan around it.

Unique device identification

Brazil’s UDI system is being phased in by risk class, starting with the highest-risk devices and moving to lower classes over the following years, with a later schedule for submitting data to the national UDI database. Confirm the current dates for your class. Our UDI guide explains the shared structure of UDI-DI and UDI-PI so you can reuse your work from the US and EU.

After registration

• Technovigilance: the BRH reports adverse events and field actions to ANVISA under Brazilian timelines. Align your global complaint process with Brazil: see CAPA and complaint handling and post-market surveillance.
• Changes: changes to a registered device may need a pre-approval, a post-notification or no filing, depending on the type. Build Brazil into your change control process.
• Renewal: submit renewal applications within the allowed window before expiry.

Common mistakes

• Starting the file before the GMP route is decided, then waiting months for an inspection slot.
• Forgetting INMETRO or ANATEL certification, which blocks the submission.
• Assuming a previous class still applies after the move to RDC 751/2022.
• Poor control over Portuguese labels, which must match the dossier and the registration.
• Choosing a BRH without checking that it can support recalls and inspections.
• Letting the registration or the GMP certificate lapse.

Frequently asked questions

Do all devices need a registration in Brazil?

No. Class I and II devices use notification, which is faster and does not expire. Class III and IV devices need registration, which is more detailed, usually needs the Brazilian GMP certificate and must be renewed.

Can my MDSAP certificate replace the ANVISA inspection?

It can support or replace it when the certificate scope includes Brazil and matches your site and product. You must still request the Brazilian GMP certificate and follow ANVISA’s process, but the on-site inspection can be waived.

Do I need a company in Brazil?

You need a Brazilian legal entity as BRH. It does not have to be your own subsidiary, and many manufacturers use a distributor or an independent service provider.

Can I use English documents?

Labels and instructions for use must be in Portuguese. Other technical documents can often be submitted in Portuguese, English or Spanish, but confirm the current rule for each document type.

How long does registration take?

Notifications are comparatively quick. Registrations commonly take many months and can take longer when an inspection is needed, so build the GMP and certification steps into the schedule from the start.

ANVISA resolutions, fees and deadlines are updated often, and many are published in Portuguese. Confirm current requirements with ANVISA, your BRH and your regulatory advisers before you act on this guide.

Related reading

• Global market access beyond the US and EU: compare Brazil with other markets and sequence your launches.
• ISO 13485 and MDSAP audit readiness: one audit, several regulators.
• Health Canada medical device licence: another MDSAP-driven market.
• China NMPA registration: a contrasting long-lead market.
• RAC (Devices) study material: covers ANVISA and other global systems.

Talk to the AptSkill team

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