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.
STEP 1: CLASSIFICATION & SCOPE
Determine the classification and grouping of your products in accordance with ANVISA guidelines to determine if Notification or Registration is required. Medical devices and IVDs are classified into four tiers (Class I, II, III, and IV) based on increasing risk. Class I and II products follow the Notification route; Class III and IV products follow the Registration route.
STEP 2: REPRESENTATION & OPERATIONS
Appoint a Brazil license holder (also known as a Brazil Registration Holder) who will act as the manufacturer’s main point of contact with ANVISA and submit your Notification or Registration to ANVISA. Your license holder must be based in Brazil and coordinates pre- and post-market compliance activities, including coordinating quality management system (Brazil GMP) inspections and certifications, device renewals (if required), device recalls and incident reports, and import authorizations. From our office in Brazil, Pure Global can act as your Brazil license holder.
STEP 3: ASSESS & ANALYZE
Evaluate documentation compliance by identifying and closing any potential gaps.
Documentation requirements for ANVISA Notifications include:
Documentation requirements for ANVISA Registrations include:
Once we receive all compliant documentation for your product, your ANVISA Notification can be submitted in less than one week. Learn more about AI-Supported ANVISA Submissions.
STEP 4: PREPARATION & COMPILATION
Gather technical documents and necessary certifications (such as INMETRO, ANATEL, INCQS) if applicable. For Class III and IV devices, obtain Brazil Good Manufacturing Practices (BGMP) certification for your manufacturing site, which includes an inspection by ANVISA. Complete the technical dossier as defined in Chapter VII of RDC 751/2022.
STEP 5: SUBMISSION
Submit the dossier to ANVISA via your Brazil license holder.
STEP 6: DECISION
ANVISA reviews the dossier and issues a decision based on the completeness and accuracy of the submitted documentation. Notifications require minimal review, and decisions are issued within 30 days. Registrations can take 4-12 months for ANVISA review and approval, depending on the device type and risk classification.
STEP 7: POST-MARKET RESPONSIBILITIES
After approval, you must comply with post-market obligations to finalize your registration and maintain compliance with ANVISA’s requirements:
Once approved and registered, the product can be legally imported, marketed, and sold in Brazil. Notifications do not expire, but Registrations must be renewed every 10 years. BGMP certifications must also be renewed every two years. If you fulfilled the BGMP requirement via Medical Device Single Audit Program (MDSAP) certification, you must renew every four years.
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 compilation, representation, and post-market compliance. Starting at $2,000/year.
The cost of registering a medical device with ANVISA depends on the device classification, whether Brazilian GMP (BGMP) certification is required, and whether additional certifications apply.
Ongoing costs after approval include annual payments to the in-country representative for import letters, modifications, PMS, and vigilance activities.
Renewal and maintenance costs for INMETRO and ANATEL certificates are typically $1,000 per certificate per year. For Class III/IV devices, the $13,500 BGMP fee recurs every 2 or 4 years, depending on whether MDSAP certification is leveraged.
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.
Yes, local representation is mandatory under Brazil's medical device regulations. Companies must have authorization from ANVISA to commercialize medical devices in Brazil, covering processes such as import, export, manufacturing, and distribution. Additionally, electromedical equipment must secure INMETRO certification, and devices with telecommunications features require ANATEL certification.
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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