ANVISA Notification and Registration
Get your product legalized with strategy, consistent documentation, and full support until publication.
WHO DO WE SERVE?
Distributors / Importers (wholesale trade)
Aesthetic, dental, and medical clinics
Transport companies, warehouses, and logistics operators
Manufacturers
Other establishments subject to the oversight of the Health Surveillance Agency.
CLIENTS
Get your product legalized wiRegulate your product with safety, agility, and full compliance, with the support of DSL Consult
When it comes to placing a regulated product on the Brazilian market, ANVISA requires products to go through either notification or registration, depending on the type and risk level of the product. These processes are essential to ensure compliance with sanitary regulations and to protect consumer safety.
DSL Consult offers specialized support for ANVISA product notification and registration, ensuring that your product is regularized in accordance with current legislation, efficiently and without avoidable errors. Our consulting team manages the entire process, from the initial assessment to final approval, allowing your company to operate safely and with the required authorizations in place.
Empresas que atendemos
Empresas que atendemos
What Are ANVISA Notification and Registration?
The process of notifying or registering a product with ANVISA is essential to ensure that the product is authorized for commercialization in Brazil. However, the difference between notification and registration often causes confusion. Below is a clear explanation of how each process works and how it affects your company.
Notification
Notification is generally used for lower-risk products, such as cosmetics, personal care products, dietary supplements, and similar categories. In this process, the manufacturer or importer informs ANVISA about the commercialization of the product.
In these cases, ANVISA does not usually perform a detailed technical review, but it still requires the product to comply with legal requirements and to be supported by sufficient documentation to ensure consumer safety.
Registration
Registration is required for higher-risk products, such as medicines, medical devices, healthcare products, and foods with health claims.
For these products, ANVISA performs a more rigorous assessment, reviewing the product’s safety, efficacy, and quality. The registration process is more complex and requires more robust technical documentation and supporting evidence, such as clinical studies and safety testing.
In both cases, consistent and well-prepared documentation is essential. This is where DSL Consult helps ensure that your company does not lose time or face unnecessary risk of rejection or delay.
ANVISA Notification and Registration is essential for companies working with regulated products, such as:
Manufacturers and importers of medicines, cosmetics, medical devices, food products, dietary supplements, and other ANVISA-regulated products
Industrial companies that need to ensure their products are regularized and ready for commercialization in Brazil
Distributors and commercial representatives dealing with regulated products who need to ensure the items are properly notified or registered for distribution
Companies that already have products on the market but have not yet fully regularized their notification or registration process
If you work with regulated products and need to ensure they are approved by ANVISA before being commercialized in Brazil, this service is essential for your operation.
Ensure Excellence
Who is this service recommended for?
Businesses in cosmetics, medical devices, healthcare products, sanitizing products, food, pharmaceuticals, and other sectors regulated by ANVISA.
Business owners, startups, distributors, manufacturers, and professionals looking to regularize their operations or acquire already-regularized companies.
Specialized consulting for transport companies that wish to operate with products subject to health surveillance regulations, ensuring compliance at every stage of the operation.
1
Companies We Serve
2
Who We Support
3
Transport Companies
Practical Benefits
Compliance with ANVISA requirements
With notification or registration completed, your company can operate legally and with greater legal certainty, without the risk of having products blocked or suspended.
Fewer issues during inspections
Regularizing your products helps reduce the risk of fines or enforcement actions by ANVISA and ensures your company is better prepared for inspections and audits.
More credibility and trust in the market
ANVISA notification or registration adds an important level of credibility to your product, making it more attractive to clients, distributors, and business partners.
Frequently Asked Questions
“What is the difference between notification and registration?”
Notification is generally for lower-risk products, such as cosmetics, food products, and supplements, where ANVISA records the commercialization of the product. Registration is required for higher-risk products, such as medicines and medical devices, where ANVISA performs a detailed evaluation of safety and efficacy.
“How long does it take to obtain notification or registration?”
The timeline may vary depending on the type of product and the complexity of the documentation. The process can take anywhere from 30 to 180 days, depending on factors such as the product category and the need for additional testing.
“Can I sell my product while it is still under notification or registration review?”
No. The product may only be commercialized after ANVISA has granted the required notification or registration.
