Medical Device Regulatory

MEDICAL DEVICE REGULATORY
REQUIREMENTS FOR
BRAZIL
Date: 3/21/02
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and is current to the best of our knowledge. For exposit and definitive information about
a countrys laws and policies, the administration of the country should be consulted.
Brazilian National health concern Agency (ANVISA)
On December 31, 1998 the Brazilian President subscribe a Provisional Measure # 1791,
that created ANVISA Agência Nacional de Vigilância Sanitária (Brazilian National
Health Vigilance Agency) and established a new user fees grammatical construction for companies and
products adjustment, as set out in the matrix below. The user fees and new certification
rules affect medical devices and equipment, pharmaceuticals, vitamins and food
products, cosmetics, tobacco and certain sanitisation products, which must be registered
with ANVISA prior to sale in Brazil. The topical anesthetic representative of the US company should
be responsible for the registration of the products.
President Cardoso signed the Presidential Decree #3029 of April 16, 1999, effectively
creating the ANVISA and regulating a series of other Provisional Measures and
Regulations incorporating the recent negotiations with the Brazilian sexual congress and the
local market.



The same Decree, published on the Brazilian official Gazette on April 27,
1999 sets out the Internal Regulation of ANVISA, fit in to which the Director
President of the Agency is nominated by the President for a five year period of work.
ANVISA is fashioned after the FDA - intellectual nourishment and Drug Administration to substitute SVS National Secretary of vigorous Vigilance, instituted by Law # 6360 of 1976. In this new
capacity, the new agency has enforcement powers confusable to FDA, including cancellation
of operation permits for drugs, food and medical product manufacturers and distributors.
The Brazilian agency, however, was created as a public company, under a contract to
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