REGULATORY AND APPROVAL PROCESSES TO ENTER THE BRAZILIAN MARKET

Imported products controlled by ANVISA the National Sanitary Vigilance Agency, including pharmaceuticals, vitamins, cosmetics and medical devices products, can only be sold if:

♦  The foreign company establishes a local Brazilian manufacturing unit or local office, fully responsible for its products; or

♦  The foreign company appoints a Brazilian distributor, who has the registration with the ANVISA as an importer and distributor of the types of products being offered.

Any product that comes in contact with the human body and could present any health risk falls under these requirements.

Note:

Any and all products related to health, applied to the skin, injected into the body or even inserted into the eye (contact lens and cleaning liquids, for example), and any other having a medical application have to be registered with ANVISA.

The presence of the company in Brazil (either through a local office or the Brazilian Distributor) is mandatory.

Therefore, the first step a foreign company must take is to decide whether it is going to commercialize its products, through the Brazilian distributor or through its own structure in Brazil.

With either option, the distributor has to be duly registered at ANVISA and authorized to operate by the sanitary agencies – both municipal and federal jurisdiction. The documents mentioned below are absolutely essential for all type of product registration.

DOCUMENTS REQUIRED OF LOCAL DISTRIBUTORS FOR PRODUCT REGISTRATION, IMPORTATION AND SALES IN BRAZIL

♦ Operating License - A trading permit granted by the state or municipality sanitary authorities. This allows the company to import, distribute, store and sell the product registered with the ANVISA. 

Note: this document belongs to the local company. 

♦ Authorization of Company Operation - A permit like the "Alvará de Funcionamento", but granted by the Federal Government.

Note: this document belongs to the local company.

♦  Contract with a qualified technician (such as a chemist, pharmacist, engineer, etc, ac-cording to different types of industry). This is called "Terms of Technical Responsibility", signed by the professional. This document can be obtained from the Regional Pharmaceutical Council.

♦  Contract with a local Brazilian laboratory to do the quality control certificate for each one of the products to be registered. This laboratory must be an "OCC-Organismo de Controle e Certificação", (Control and Certification Laboratory) an official registered certification organization, registered with the Brazilian Health Agency (ANVISA). The company has 12 months to provide this information. The company can use any laboratory authorized by the ANVISA. 

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IMPORTANT NOTE

Information of a guidance, without claiming to cover all existing legislation or to ensure your upgrade. Always consult the relevant regulatory bodies for such security. The PLATINUM Consulting is happy to answer questions relating to Regulatory Affairs is making available if you need more detail.