ANVISA Brazil Medical Device Registration

Pure Global offers comprehensive assistance with ANVISA Brazil medical device registration, ensuring that global manufacturers can navigate the regulatory landscape of Brazil's healthcare market effectively. Brazil, with its substantial population of 214 million, stands as the eighth-largest healthcare market globally and imports about 50% of its medical devices and IVDs. The recent legislative changes in Brazil that open public tenders to international companies further enhance the attractiveness of this market, provided that these companies comply with local regulations.

The regulatory process in Brazil is overseen by ANVISA (The National Health Surveillance Agency), which classifies medical devices into four risk-based categories: Class I (Low Risk), Class II (Medium Risk), Class III (High Risk), and Class IV (Maximum Risk). Classes I and II devices are subject to a notification process with ANVISA, and once approved, the notification is valid indefinitely. Classes III and IV devices, on the other hand, require B-GMP certification prior to registration, with approvals lasting for 10 years.

Key steps for manufacturers looking to enter the Brazilian market include comprehensive submissions detailing the device's information, clinical data, and safety and efficacy studies. Post-Market Surveillance is also crucial, as it involves continuous monitoring of the device’s performance, collecting data on adverse events and patient reactions to ensure ongoing safety and effectiveness.

Local representation is mandatory in Brazil. Manufacturers must partner with a company that holds an operating authorization from ANVISA for activities including import, export, manufacturing, distribution, storage, and transportation. Additionally, devices that are electromedical must also secure INMETRO certification, and those with telecommunications features need ANATEL certification.

Pure Global aids in classifying and grouping products to determine the appropriate regulatory pathway, compiling the necessary technical dossier for ANVISA registration, and acting as a local representative for the submission process. They also coordinate certifications from INMETRO and ANATEL as required and provide ongoing support for post-market surveillance and regulatory compliance, ensuring a smooth and successful market entry into Brazil.

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