With around 50% of medical devices and IVDs imported, Brazil presents a lucrative opportunity for global manufacturers. Recent changes to ANVISA Brazil medical device registration requirements have made it more accessible, especially to manufacturers with authorizations in other markets.
Pure Global simplifies the process with AI workflows that accelerate ANVISA submission preparation, along with local support and representation, all for a flat annual fee.
Brazil’s medical devices market is set to reach $7.3B by 2028, growing at a 5.1% CAGR. Growth is driven by higher healthcare spending and faster approvals, despite economic pressures. An aging population and universal healthcare sustain demand.
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)
Registration Route (Class III & IV devices and IVDs)
Other ANVISA registration requirements
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):
For Registration (Class III & IV devices):
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:
If your device falls under any of these categories, certification must be obtained in addition to ANVISA registration, and you must have a legal representative in Brazil to manage the process. Compliance marks must be visible on the device.
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.
We leverage proprietary AI to expedite your entry into Brazil's healthcare market:
ANVISA submissions are ready in half the time with our AI workflow.
Expert reviews ensure your submission is compliant and ready for approval.
We act as your license holder and submit your dossier to ANVISA from our Brazil office.
Flat fee includes translation from English to Portuguese, submission, and distributor authorizations. Starting at $2,000/year.
Timelines for ANVISA registration vary by device class and certification requirements:
In summary, low-risk devices can reach market in about a month, while higher-risk devices may require up to a year, particularly when BGMP certification is included.
ANVISA charges mandatory government fees based on device risk class and regulatory pathway:
All fees listed are government fees only and do not include consulting services, dossier preparation, translations, or in-country regulatory representation. Additional fees can apply; fees can also change without notice.
Check our Fee Calculator for up-to-date government fees in 14 markets.
Pure Global offers flat-fee annual pricing for bundled medical device and IVD registration and representation in Brazil, starting at $2,000/year. The flat fee includes dossier preparation and submission, in-country representation, translation, modifications, distributor authorization, and post-market support. The fee does not include ANVISA or other government fees, certified translations, or translations from languages other than English.
Flat fee structure for Class I/II Risk devices:
1 device = $2,000/year
2-5 devices = additional $1,000 per device per year (e.g., 4 devices = $5,000/year)
6-10 devices = additional $500 per device per year (e.g., 8 devices = $7,500/year)
Flat fee structure for Class III/IV Risk devices:
1 device = $3,000/year
2-5 devices = additional $1,500 per device per year (e.g., 4 devices = $7,500/year)
6-10 devices = additional $1000 per device per year (e.g., 8 devices = $12,000/year)
Contact us for a custom quote if you have 11+ devices.
A three-year contract is required to lock in the fees quoted above. However, other contractual arrangements are available. Use our Fee Calculator for an instant estimate and more information about flat fee terms.
When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
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