Brazil, the heart of Latin America, boasts a population of 214 million and ranks as the eighth largest healthcare market globally. 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 further open its public tenders to international players, provided they align with local company processes.
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.
Brazil's medical device regulator is The National Health Surveillance Agency, also known as ANVISA (Agência Nacional de Vigilância Sanitária). Pure Global can assist with Brazil's medical device registration and act as your Brazil Registration Holder (BRH), ensuring ANVISA approval to sell in the Brazilian market.
ANVISA classifies medical devices according to the risk they present. This classification is essential to determine the safety and efficacy requirements that each product must meet. The classification categories are Class I (Low Risk), Class II (Medium Risk), Class III (High Risk) and Class IV (Maximum Risk). Class I and II devices require only notification to ANVISA. With approval, the notification remains in force for an indefinite period. Class III and IV devices require B-GMP certification before a formal registration, with approval the registration is valid for 10 years.
The journey to market medical devices involved comprehensive submissions to ANVISA, including detailed information about the device, clinical data, safety and efficacy studies, among others. This process also includes the marketing approval process and Post-Marketing Surevillance, which involves continous monitoring of the device's performance during its use. Data on adverse events, failures, and patient reactions are collected to ensure the safety, effectiveness, and high quality of medical devices throughout their life cycle.
Local representation is crucial, as it is mandatory to have a company with operating authorization from ANVISA to commercialize medical devices in Brazil. This authorization is required for processes such as import, export, manufacturing, distribution, storage, transport, and B-GMP.
Additionally, electromedical equipment must secure INMETRO certification, and devices with telecommunications features require ANATEL certification, ensuring full compliance with Brazilian regulations.
Leverage our expertise to simplify your entry into Brazil's healthcare market:
Classification and grouping of products to identify the regulatory pathway.
Compilation of the technical dossier for ANVISA registration.
Acting as your local representative for submission to ANVISA and coordinating certifications from INMETRO or ANATEL, as necessary.
Providing post-market surveillance and regulatory compliance support to ensure your success.
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 an annual fee to the local representative for post-market obligations (e.g., import letters, modifications, vigilance), estimated at ~$5,000 per year, with additional maintenance costs for INMETRO/ANATEL certificates (around $1,000 per certificate). For Class III/IV devices, the $13,500 BGMP fee recurs every 2 or 4 years, depending on whether MDSAP is leveraged.
Timelines for ANVISA registration vary significantly 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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