In order to diminish prices and increase the population's access to medical and hospital equipment that are not produced in Brazil, the government created a regime that grants tax exemptions for these products to be imported.
The Senate’s Economic Affairs Commission (CAE) approved, in 2011, the tax exemption for medical and hospital equipment in Brazil. The measure aims to increase the population access to these technologies, since the exemption concedes a reduction of up to 20% in the products prices. The regime applies to:
Products Free from Taxation
The exemption comprises medical and hospital equipment that doesn't have a national equivalent and are listed in the Ministries of Finance and Health, with the exemption also extended for its re-position parts and pieces. The goods free from taxation are the ones comprised in the classes of:
- hygiene products
- cleaning products
- food products
- products for in vitro diagnostic
- medical products and their pieces and parts designated to the prevention, diagnosis, treatment and rehabilitation of human individual and collective health.
Acquiring the Exemption
To be in accordance with customs regulations regarding the tax exemption for medical and hospital equipment, the importer must submit a request to the competent health authority at the ANVISA headquarters with the following documentation:
Documents Required for the Application
- application for Sanitary Inspection and Release of imported goods - issued by ANVISA
- application for the Recognition of Import Duty Exemption for medical and hospital equipment
- original Union Collection Guide (GRU)
- updated copy of Import License Extract or Simplified Import Licensing
- information about the ANVISA regularization of the product, when necessary
- declaration or power of attorney issued by the company authorizing the importation by third parties, when appropriate
- declaration signed by the legal representative of the company, a commitment made by the importer, informing that the goods imported will be designated for the exclusive use of the importing company, indicating location (s) for installation and use or consumption of the goods
- specify the full name and address of the bonded warehouse where customs clearance will take place.
The documentation and the request must be forwarded to:
- Setor de Indústria e Abastecimento or Industry and Supply Sector (SIA) - Trecho or Strecht 5, Área Especial or Special Area 57, Brasília (DF) - CEP: 71205-050
Imported Products and ANVISA Authorization
When imported goods need the ANVISA authorization and are imported by a person who doesn't have the authorization, a power of attorney or a declaration must be presented to ANVISA. It must be signed by the company that holds the authorization allowing each import. The power of attorney or declaration must be presented in its original form and in copy (that will be collected and notarized by ANVISA) and must also:
- be bound to a single company, with the transfer of the ANVISA authorization to another person or entity forbidden
- present legal validity and have been signed within 90 days prior to the presentation
- be signed by their legal guardian or legal representative, and by its technical manager with notarized signature in the original and in the copy
- express the commitment to the rules and procedures established by the health law, and know the penalties which will be subject, in accordance with Law n. 6.437, of August 20, 1977.
After ANVISA approval for the tax exemption, the importer must accomplished the obligation to respect and enforce the declared purpose of the imported good when it is used or exposed to the national territory.