{"id":7130,"date":"2021-09-19T18:53:49","date_gmt":"2021-09-19T21:53:49","guid":{"rendered":"https:\/\/passarini.com.br\/brazil\/compliance-certification-inmetro-2\/"},"modified":"2021-10-19T16:22:20","modified_gmt":"2021-10-19T19:22:20","slug":"anvisa-license","status":"publish","type":"page","link":"https:\/\/passarini.com.br\/en\/brazil\/anvisa-license\/","title":{"rendered":"Anvisa Notification and Registration | Passarini"},"content":{"rendered":"

What is <\/b>ANVISA License<\/b>?<\/b><\/h1>\n

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.<\/span><\/p>\n

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 \u2013 that is, it is an autonomous body of public administration with juridical personality, acting in the sanitary control of national and imported products.<\/span><\/p>\n

For <\/span>ANVISA consulting service<\/span><\/a>, count on Passarini Group. <\/span>Contact us now<\/span><\/a>!<\/span><\/p>\n

Is <\/b>ANVISA License<\/b> Mandatory?<\/b><\/h2>\n

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, th<\/span>ministrative 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.<\/p>\n

How to get an ANVISA License?<\/b><\/h2>\n

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.<\/span><\/p>\n

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.<\/span><\/p>\n

Products For Personal Usage<\/b><\/h2>\n

Since 2013, January, there’s no need to present an <\/span>Anvisa License<\/span> 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 Importa\u00e7\u00e3o para Consumo Pessoal \u2013 importation for personal usage.<\/span><\/p>\n

If these products were imported in large quantities the importer must request an import permit to GIPAF (Ger\u00eancia de Inspe\u00e7\u00e3o de Produtos e Autoriza\u00e7\u00e3o de Empresas em Portos, Aeroportos, Fronteiras e Recintos Alfandegados) and if the permit was granted the importation can continue.<\/span><\/p>\n

Products For Professional Usage<\/b><\/h2>\n

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.<\/span><\/p>\n

Products For Commercialization<\/b><\/h2>\n

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.<\/span><\/p>\n