ANVISA Brazil Medical Device Registration
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.
Navigating Brazilian Regulations
Regulatory Authority
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.
Classification
The National Health Surveillance Agency (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.
Key Requirements
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.
Tailored Support for Market Entry
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.
Frequently
Asked Questions
What is the role of ANVISA in Brazil's medical device registration?
ANVISA, the National Health Surveillance Agency, is responsible for classifying and approving medical device Brazil, ensuring they meet safety and efficacy standards. Pure Global can assist international manufacturers in navigating this process.
How are medical devices classified in Brazil?
For Brazil medical device registration, ANVISA classifies devices based on risk: 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, while Class III and IV devices need B-GMP certification and formal registration, valid for 10 years.
What are the key requirements for registering a medical device in Brazil?
Registering a medical device in Brazil involves comprehensive submissions in compliance with ANVISA regulations, including detailed device information, clinical data, and safety and efficacy studies. Additionally, continuous Post-Marketing Surveillance is required to monitor the device's performance and ensure ongoing safety and effectiveness.
Is local representation necessary for medical device registration in Brazil?
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.
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