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Brazil Standards: Medical Instruments/Devices

Come here to discuss the Brazil's standards of various industry, products registration and import regulations as well as tariff information.

Brazil Standards: Medical Instruments/Devices

Postby bridgat » Mon Nov 17, 2008 3:44 pm

Brazil has a large medical equipment and product markets supplied from both and foreign sources.

Regulatory Agency
The organization in charge of regulating medical device imports in Brazil is the Ministry of Health. In 1998 the Brazilian National Health Vigilance Agency (ANVS), an agency similar to the U.S. Food and Drug Administration, was created to help monitor medical devices. All medical devices must be registered with ANVS in order to be sold in Brazil.

Import Licenses
Only licensed importers can import products into Brazil. Import licenses are issued by the Foreign Trade Secretariat (SECEX) of the Ministry of Industry, Commerce and Tourism.

The following information is required for registration of medical devices:
< Name of company
< Address
< Product name
< Product Description
< Legalized FDA Certificate to Foreign Government (CFG)
< Final Product Drawings
< List of Components/Materials
< Manufacturing Method (Flow Chart)
< Labels/Directions for Use
< Sterilization Parameters
< Quality Control Test Methods/Records
< Clinical Publications
< Product Brochure (Catalog Page)

Additional documents required for Mercosul registration:
< Letter of Authorization
< Packaging Materials
< Quality Control Certificate
< Biocompatibility Reports
< FDA status

Products Currently Exempt from Import Duties and VAT taxes
To lower the cost of medical device imports, the Brazilian government reduced the import duties and VAT taxes on forty-two medical device products to 0%. The product group types are listed below:
* Isotopes and radioactive compounds
* Catgut, surgical sutures and similar products
* Blood typing reagents
* Preparations for radiological examination
* Cement and similar preparations for dental filling
* X-ray films and similar goods
* Other X-ray films
* Culture media for microorganisms development
* Diagnostic reagents for laboratory testing
* Plastic Tubes for special applications
* Plastic washers for utilization in urology equipment
* Surgical gloves
* Syringes
* Instruments and apparatus for blood transfusion, kidney treatment, endoscopes and related products
* Prostheses
* Orthopedic products
* Other prostheses products (heart valves, intraocular lenses)
* Other - automatic defibrillators

Brazil usually accepts U.S. product standards and certifications by U.S. testing laboratories such as Underwriters Laboratory.

Product labels must contain information about the product's quality, quantity, composition, price, guarantee, shelf life, origin, and risks to the consumer's health and safety. Labels should have a Portugese translation and should use metric units or show a metric equivalent.

The information contained on this website is derived from public sources and is current to the best of our knowledge. For detailed and definitive information about a country’s laws and policies, the government of the country concerned should be consulted.
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