What is ANVISA?
ANVISA, abbreviated from Portuguese “Agencia Nacional de Vigilancia Sanitaria,” is the food and drug regulatory agency in Brazil. ANVISA Registration has been a requirement for businesses operating in Brazil since the regulator was created in 1999. ANVISA Regulations aim to protect and promote public health, by exercising health oversight over products and services, including processes, ingredients, and technologies that may pose health risks for users.
How Can I get ANVISA Registration?
If your company does not have physical headquarters in Brazil, you can use an ANVISA consulting Services provider to be your Brazil Registration Holder (BRH). This company will handle the registration of your device in Brazil.
How Can Passarini Help You Comply With Anvisa Regulations?
Passarini offers ANVISA consultation services in Brazil and boasts of a team of experienced specialists with extensive knowledge of the ANVISA Regulations and Certification process. We work with you every step of the way to guarantee successful registration and certification of your products.
Our experts help you with all your ANVISA registration needs and submissions irrespective of your risk category. Our areas of specialty include registration for;
- Make adjustments to your product documentation to ensure it is compliant with ANVISA regulations
- Help you understand ANVISA’s medical device classification, clinical evaluation, sterilization validation, and material tests
- Offer you a dedicated team for the registration and certification of implantable materials
In case you need assistance with developing any kind of project documentation for your products that need ANVISA registration, our experts can help your team create compliant documentation for;
- Risk management
- Process validation
- User Manuals
You do not need to worry if your documentation is in a different language. Our ANVISA Consultation Services include translation and localization of documents for you at a below-market cost.
Let Passarini help you make your product viable for use in the Brazilian market with our ANVISA Regulatory services today!
For more information, feel free to get in touch with us.
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