What is ANVISA License?

ANVISA (National Health Surveillance Agency) is a national sanitary surveillance agency, responsible for promoting the protection of health, intervening in the inappropriate use of substances, through the sanitary control of productions and products.

Sanitary surveillance comprises several actions that aim to eliminate and/or reduce risks to the health of the population. In Brazil, all actions related to sanitary surveillance are carried out by ANVISA. ANVISA was founded on January 26, 1999, and is classified as a regulatory agency, in the form of an autarchy – that is, it is an autonomous body of public administration with juridical personality, acting in the sanitary control of national and imported products.

For ANVISA consulting service, count on Passarini Group. Contact us now!

Is ANVISA License Mandatory?

In the case of importing medical devices, medicines, cosmetics, food or other items that might threaten public health, they need sanitary approval to be nationalized. In Brazil, thministrative treatment of these products indicates the need for an Anvisa Import License (LI ANVISA) carried out by ANVISA. With non-automatic licensing, the cargo will only be released after an inspector checks the information provided.

How to get an ANVISA License?

One of the first steps to access ANVISA’s services is to register a company with ANVISA. The registration of companies at Anvisa is done through the Company Registration System and user registration through the Security System.

In addition to allowing the registration of the company, the system also requests the registration of users linked to the company, who will be responsible for accessing other ANVISA systems, with a team of experts for each area.

Products For Personal Usage

Since 2013, January, there’s no need to present an Anvisa License for the importation of medicines, cosmetics, perfumes, hygiene and cleaning products, food, medical products and medicines for personal usage. The importation of these products is recognized by Anvisa as Importação para Consumo Pessoal – importation for personal usage.

If these products were imported in large quantities the importer must request an import permit to GIPAF (Gerência de Inspeção de Produtos e Autorização de Empresas em Portos, Aeroportos, Fronteiras e Recintos Alfandegados) and if the permit was granted the importation can continue.

Products For Professional Usage

If the product will be imported for usage in professional situations by a registered and qualified individual, it must follow the same steps presented above for the importation of health products for personal usage. The only particularity of this process is that the qualified individual must be registered in a health competent body recognized by Anvisa.

Products For Commercialization

The rules for each type of product monitored by Anvisa are different, varying from product to product. But usually the documentation below is always requested for every product subjected to Anvisa Licensing, but remember that, depending on the product, other documentation can also be requested.

  • Petition for Sanitary Supervision and Release (copy)
  • Union Collection Guide – GRU – (original)
  • Authorization for physical inspection
  • Commercial Invoice
  • Load Recognition of the Load embarked
  • Declaration informing the batches and the date of departures
  • Analytical Report of Quality Control of the finished product, by batch or departure, issued by the manufacturer
  • Power of attorney of the legal entity holding the regularization of the product at Anvisa to the legal representative, responsible for customs clearance.

Products For Scientific Research

Products for scientific and technological research can only be imported, when performed by a scientist/ researcher and/or by a scientific and technological institution duly accredited by CNPq – National Counsel of Technological and Scientific Development. The products designated for scientific research and subjected to the Anvisa Licensing can be imported to Brazil in two different ways:


  • Petition/ Responsibility Term manual or electronic
  • Union Collection Guide (GRU)
  • LI or LSI (copy)
  • Load Recognition (copy)

After the accomplishment of the legal requirements, the approval of the product LI / LSI will occur within 24 hours.

Through Mail Remittance

  • Petition/ Responsibility Term manual or electronic
  • Union Collection Guide (GRU)
  • LSI (copy)
  • Load Recognition (copy).

After the accomplishment of the legal requirements, the approval of the product LSI will occur within 24 hours.

For ANVISA consulting service, count on Passarini Group. Contact us now!

Who can help me get the ANVISA Certificate?

For ANVISA consulting service, count on Passarini Group, our experience in this market will bring you the shortest path in this adaptation/compliance process. We at Passarini Group know the legislation, and we know how to adapt your products in the most efficient way so that good manufacturing practices are successfully implemented and followed in your business.

Bring your project to us and we will provide you with a proposal to enable your sales in the Brazilian market. Our specialists will be able to help you with submissions in all of ANVISA’s departments (equipment, cosmetics, medicines, etc.), regardless of the risk. Contact us so that we can present our services!