Import Regulations for Pre-Owned (Used and Refurbished) Medical Devices -Brazil - Customs Forum

**admin** · 07-22-2011, 00:32 AM

General Market Condition: Restricted
Best Prospects for Non-Agricultural Goods and Services—Sector: Medical Equipment and Devices
A New Market for Refurbished Equipment
Brazil approved a law that regulates the import of refurbished medical equipment. Companies that are interested in this niche have to comply to a rigid set of guidelines, including, date of refurbishment, accurate adjustment & calibration. The refurbished equipment must meet the exact same performance of new equipment. Also, the manufacturer must provide technical assistance in Brazil or designate a local representative to provide the service.
Trade Barriers, including tariffs, non-tariff barriers and import taxes—Import Licenses
Automatic License
As a general rule, Brazilian imports are subject to the 'automatic import license' process. This procedure requires that the Brazilian importer submits information concerning each import, including description of the product as well as the harmonized tariff classification number, quantity, value of the shipment, shipping costs, etc. This information will be used for purposes of preparing the 'Import Declaration' (locally known as the DI). Subsequently, all information is fed into Brazil's customs computer system known as the SISCOMEX. The Brazilian Foreign Trade Secretariat (SECEX) is the government agency responsible for granting import licenses.
Non-Automatic License (LI)
Whenever imports are subject to the Non-Automatic License (LI) regime, the importer must provide information concerning each shipment to Brazilian customs authority either prior to shipment or prior to customs clearance. The required information includes a description of the product as well as the harmonized tariff classification number, quantity, value of the shipment, shipping costs, etc.

Prior to Customs Clearance: Products imported under the drawback regime, as well as imports destined to the free trade zones and the National Council for Scientific and Technological Development.
Prior to Shipment Clearance: Products subject to special controls from SECEX or which require approvals from other Brazilian government agencies. Such products may include: used products in general, products that enjoy import tariff reductions, imports that do not involve payment from importer to the exporter -- eg, samples, donations, temporary admission, psychotherapeutic drugs, products for human or veterinary research; weapons and related products, radioactive products and rare earth metal compounds, crude oil, oil derivatives or other petroleum derivatives, anti-hemophilic serum, medications with plasma and human blood, products that may be harmful to the environment—eg, CFC, mailing machines, stamp selling machines, airplanes, etc.

Shortly after feeding the SISCOMEX system information concerning a specific shipment, the SISCOMEX system will indicate whether or not a 'non-automatic import license' is required.
On February 15th 2001, ANVISA (National Health Administration Agency) published resolution RDC nº 25, which regulates imports of used medical equipment. The resolutation imposes strict requirements that used equipment must meet before it can be imported into the country. Some of the requirements include:

Registration with Brazil's Vigilancia Sanitaria agency. If the product does not require such registration, submit evidence to support your claim;
Obtain an import license. The license must state the country of origin, detailed information of product, name of manufacturer, model and technical specifications;
The equipment must be thoroughly cleaned and refurbished;
All parts and pieces subject to wear and tear must be replaced;
The equipment must be professionally calibrated to meet original specifications which must be certified by the original manufacturer;
New labels must be affixed and an instruction manual must be provided;
Submit the year the equipment was refurbished;
The equipment must pass thorough quality control tests; and
Make spare parts and components available in Brazil during the useful life of the equipment.

There are severe penalties for companies that do not follow the requirements listed above, including assessment of stiff fines and even confiscation of the equipment. Therefore, it is critical that US exporters of used medical equipment coordinate closely the transaction with the Brazilian importer. We also strongly advise that US companies obtain the services of a reputable Brazilian customs brokerage firm with significant experience related to imports of medical equipment.
For further information please contact
Jefferson Oliveira
Business Development Specialist
Rua Estados Unidos, 1812
01427-002 - Sao Paulo – SP
Phone: 55-11-3897-4038
Fax: 55-11-3085-9626
E-mail: Jefferson.Oliveira@mail.doc.gov

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