ANVISA Brazil Medical Device Registration

Medical devices and IVDs sold in Brazil are regulated by the Agência Nacional de Vigilância Sanitária (ANVISA), Brazil’s national health surveillance agency. The medical device regulatory framework is governed primarily by RDC 751/2022, which outlines classification rules, documentation requirements, and Good Manufacturing Practice (GMP) expectations. IVDs are governed by RDC 830/2023.

Foreign manufacturers must appoint a Brazil license holder (also known as a Brazil Registration Holder) to represent them. This representative submits the Notification or Registration to ANVISA and serves as the main point of contact for all regulatory activities, including inspections, post-market surveillance, and importation.

ANVISA medical device regulatory pathways

ANVISA has established two primary regulatory pathways based on product risk classification. Devices and IVDs are classified into four risk-based classes: Class I, II, III, and IV.

Notification Route (Class I & II devices and IVDs)

• Process: Manufacturers of low- and moderate-risk devices submit a Notification to ANVISA via their Brazil license holder.

• Requirements: Documentation includes a Notification Form, Manufacturer Authorization Letter (for imported products), proof of compliance with applicable technical regulations, and a Certificate of Compliance (SBAC) if required.

• Timeline: Once all compliant documentation is submitted, the Notification is usually processed within 30-45 days.

• Renewal: Notifications do not expire.

Registration Route (Class III & IV devices and IVDs)

• Process: For higher-risk products, ANVISA requires full Registration, including a technical dossier and Brazil Good Manufacturing Practices (BGMP) compliance, using the applicable ANVISA certification route, which may leverage accepted MDSAP evidence rather than an identical on-site inspection for every application.

• Requirements: Required documentation includes a technical dossier (including design, manufacturing, performance, and safety data), Manufacturer Authorization Letter, Certificate of Free Sale (for imported products), BGMP certificate, proof of compliance with technical regulations, and SBAC certificate if applicable.

• Timeline: ANVISA review for Class III and IV devices typically takes 4 to 12 months, depending on device type and complexity.

• Renewal: Registrations must be renewed every 10 years. Assess the actual BGMP certificate and current validity rules; the MDSAP-based route can have a four-year validity under RDC 850/2024.

Other ANVISA registration requirements

• Brazil license holder: All foreign manufacturers must appoint a Brazil-based license holder to submit the Notification or Registration to ANVISA.

• Additional certifications: Some devices may need to obtain INMETRO, ANATEL, or INCQS certification based on their functionality prior to ANVISA submission.

• Distributor information: Distributors are authorized by and act under the regulatory oversight of the Brazil license holder.

• Translation: Instructions for Use (IFUs) must be uploaded in Brazilian Portuguese to ANVISA’s digital portal.

• Quality system evidence: Class III and IV products must comply with Brazil Good Manufacturing Practices (BGMP). Certification is issued by ANVISA following inspection or accepted under MDSAP.

• Post-market obligations: Manufacturers and license holders must conduct post-market surveillance and vigilance reporting through the National System of Health Surveillance (SNVS).

• UDI and SIUD: ANVISA’s SIUD database has operated since March 1, 2026 under IN 426/2026. Determine labeling and data-transmission deadlines from the current RDC 591/2021 framework and implementing instructions; they are distinct obligations, not one imported US/EU timetable.

What documentation is required to register a medical device or IVD in Brazil?

Documentation depends on whether the product is subject to Notification or Registration:

For Notification (Class I & II devices):

• Notification Form

• Manufacturer Authorization Letter (for imported devices)

• Certificate of Compliance (SBAC), if applicable

• Proof of compliance with applicable technical regulations

For Registration (Class III & IV devices):

• Technical Dossier

• Manufacturer Authorization Letter

• Certificate of Free Sale (for imported devices)

• Good Manufacturing Practices (BGMP) Certificate

• Certificate of Compliance (SBAC), if applicable

• Proof of compliance with applicable technical regulations

Additional documents such as INMETRO, ANATEL, or INCQS certifications may be required depending on the device type.

Does my device need INMETRO, ANATEL, or INCQS certification?

It depends on your device’s technical characteristics and intended use:

• INMETRO certification applies to products within the relevant mandatory conformity-assessment scope; electrical components alone do not establish applicability. Compliance typically involves third-party testing and factory audits by an accredited Certification Body. Some Materials also need INMETRO certification, for example, hypodermic needles, breast implants, surgical gloves and gloves for non-surgical procedures, condoms.

• ANATEL certification is mandatory for devices that use telecommunications technology, including Wi-Fi, Bluetooth, or other wireless communication. Devices must undergo technical testing and type approval through a Designated Certification Body.

• INCQS evaluation may apply to certain In Vitro Diagnostic products related to the diagnosis of Dengue, Chikungunya, Sars-Cov 2 (self-test), as well as those intended for screening tests in blood banks: reagents for immunohematology (ABO system, Rh system and irregular antibodies), Hepatitis B and C, Syphilis, HIV, Chagas and HTLV.

Confirm the exact applicable certification or evaluation scope, including any recognized module or exemption, before arranging tests. Coordinate it with the ANVISA notification or registration and local-holder process. Apply only the marking and identification rules required for that certification; an INCQS evaluation is not a universal product-certification mark.

What is a Brazil license holder and why do you need one?

A Brazil license holder (or Brazil Registration Holder (BRH)) is a legal entity based in Brazil that acts on behalf of a foreign manufacturer to interface with ANVISA. This representative is responsible for submitting the device Notification or Registration, ensuring regulatory compliance, and coordinating pre- and post-market activities. This includes managing BGMP inspections, submitting recalls and vigilance reports, uploading labeling in Portuguese, and issuing import authorizations. Only Brazilian entities can act as license holders, making them a mandatory partner for foreign manufacturers.

Certification, evidence and launch sequencing

Use the current ANVISA registration instructions and UDI portal. Notification does not remove the duty to maintain a complete compliant file. Separate dossier preparation, certification, authority processing and applicant-response time in the launch plan; published averages are not guaranteed outcomes.