![\"anvisa](\"https:\/\/passarini.com.br\/wp-content\/uploads\/2017\/05\/1920x500_banner_registros-e-cadastros-1.webp\")
<\/span><\/li><\/ul><\/div><\/div><\/div><\/div><\/div><\/div>What is ANVISA?<\/h1>\n
ANVISA, abbreviated from Portuguese \u201cAgencia Nacional de Vigilancia Sanitaria,\u201d is the food and drug regulatory agency in Brazil. <\/span>ANVISA Registration<\/span> has been a requirement for businesses operating in Brazil since the regulator was created in 1999. <\/span>ANVISA Regulations<\/span> 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.<\/span><\/p>\n
How Can I get ANVISA Registration?<\/b><\/h2>\n
If your company does not have physical headquarters in Brazil, you can use an<\/span> ANVISA consulting Services<\/span><\/i> provider <\/span>to be your Brazil Registration Holder (BRH). This company will handle the registration of your device in Brazil.\u00a0<\/span><\/p>\n
How Can Passarini Help You Comply With Anvisa Regulations?<\/b><\/h2>\n
Passarini offers <\/span>ANVISA consultation services<\/span> in Brazil and boasts of a team of experienced specialists with extensive knowledge of the<\/span> ANVISA Regulations<\/span><\/i> and Certification process. We work with you every step of the way to guarantee successful registration and certification of your products.<\/span><\/p>\n
Our experts help you with all your <\/span>ANVISA registration<\/span> needs and submissions irrespective of your risk category. Our areas of specialty include registration for;<\/span><\/p>\n
- \n
- Materials<\/span><\/li>\n
- IVDs<\/span><\/li>\n
- Equipment<\/span><\/li>\n
- Sanitizers<\/span><\/li>\n
- Cosmetics<\/span><\/li>\n
- Medicines<\/span><\/li>\n<\/ul>\n
We also;<\/span><\/p>\n
- \n
- Make adjustments to your product documentation to ensure it is compliant with <\/span>ANVISA regulations<\/span><\/li>\n
- Help you understand ANVISA\u2019s medical device classification, clinical evaluation, sterilization validation, and material tests<\/span><\/li>\n
- Offer you a dedicated team for the registration and certification of implantable materials<\/span><\/li>\n<\/ul>\n
In case you need assistance with developing any kind of project documentation for your products that need <\/span>ANVISA registration,<\/span> our experts can help your team create compliant documentation for;<\/span><\/p>\n
- \n
- Risk management<\/span><\/li>\n
- Usability<\/span><\/li>\n
- Process validation<\/span><\/li>\n
- User Manuals<\/span><\/li>\n<\/ul>\n
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.<\/span><\/p>\n
Let Passarini help you make your product viable for use in the Brazilian market with our <\/span>ANVISA Regulatory services <\/span>today!<\/span><\/p>\n
For more information, feel free to get in touch with us.<\/a><\/strong><\/span><\/p>\n
You may also be interested in:<\/span><\/p>\n
INMETRO certification<\/span><\/a><\/p>\n
ANATEL Certification<\/span><\/a><\/p>\n<\/div>
<\/div><\/div><\/div><\/div><\/div><\/div>Our Services<\/h4><\/div>
- Quality System<\/a><\/li>\n
- INMETRO Certification<\/a><\/li>\n
- ANATEL Certification<\/a><\/li>\n
- ANVISA Registration<\/a><\/li>\n
- International Licenses<\/a><\/li>\n
- Risk Management and Usability Process<\/a><\/li>\n
- Computer Systems Validation<\/a><\/li>\n
- European Representation<\/a><\/li>\n
- Process Validation<\/a><\/li>\n<\/ul><\/div><\/div>
<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>Register your product with Passarini!<\/h3>\n
The process of releasing a record in Brazil will depend on the category in which it is framed.
\nCheck out the various categories below, and contact us for more information on how to register your medical device with ANVISA.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>![\"cosmeticos_icone\"](\"https:\/\/passarini.com.br\/wp-content\/uploads\/2017\/04\/cosmeticos_icone.png\")
<\/div>Cosmetics<\/h2><\/div><\/div><\/div>
![\"equipamentos_medicos_icone\"](\"https:\/\/passarini.com.br\/wp-content\/uploads\/2017\/04\/equipamentos_medicos_icone.png\")
<\/div>Medical equipments<\/h2><\/div><\/div><\/div>
![\"Odontol\u00f3gico](\"https:\/\/passarini.com.br\/wp-content\/uploads\/2017\/04\/odontologico_cadeira_icone.png\")
<\/div>Dental equipment<\/h2><\/div><\/div><\/div>
![\"Equipamentos](\"https:\/\/passarini.com.br\/wp-content\/uploads\/2017\/04\/equipamentos_laboratoriais_icone.png\")
<\/div>Laboratory equipment<\/h2><\/div><\/div><\/div>
![\"\u00cdCONE](\"https:\/\/passarini.com.br\/wp-content\/uploads\/2017\/04\/medicamentos_icone.png\")
<\/div>Medicines<\/h2><\/div><\/div><\/div>
![\"materiais_uso_medicos_icone\"](\"https:\/\/passarini.com.br\/wp-content\/uploads\/2017\/04\/materiais_uso_medicos_icone.png\")
<\/div>Medical supplies<\/h2><\/div><\/div><\/div>
![\"Sanitizante](\"https:\/\/passarini.com.br\/wp-content\/uploads\/2017\/04\/saneantes_icone.png\")
<\/div>Sanitizing<\/h2><\/div><\/div><\/div>
![\"implantes_icone\"](\"https:\/\/passarini.com.br\/wp-content\/uploads\/2017\/04\/implantes_icone.png\")
<\/div>Implants<\/h2><\/div><\/div><\/div>
<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>Newsletter<\/h2>\n<\/div>
<\/div><\/div><\/div><\/div>Leave your e-mail in the field below to register in our newsletter and receive news and tips from Passarini every week.<\/span><\/h3>\n<\/div>
<\/div><\/div><\/div> - INMETRO Certification<\/a><\/li>\n
- Usability<\/span><\/li>\n
- Help you understand ANVISA\u2019s medical device classification, clinical evaluation, sterilization validation, and material tests<\/span><\/li>\n
- IVDs<\/span><\/li>\n
- Materials<\/span><\/li>\n