How to avoid losing time and money registering products with health authorities (ANVISA) in Brazil?
According to the Brazilian legislation, the production, manufacturing, imports, exports
and sales of any medical, pharmaceuticals and cosmetics products can only be
handled by authorized companies, registered with ANVISA - National Sanitary
Vigilance Agency, an agency of the Brazilian Ministry of Health. This is the
Brazilian counterpart of the U.S. Food and Drug Administration. You will have
below the general orientation of how this works. Then, be sure to read about
“a better solution”, following completely the laws and regulations
below.
Regulatory and approval processes to enter the Brazilian Market
Imported products controlled by the Ministry of Health, including pharmaceuticals,
vitamins, cosmetics and medical products, are sold in the country only
if:
- The foreign company appoints a Brazilian distributor, who has the registration with ANVISA as a legal, duly registered importer and distributor of the types of products being offered. Basically, any product that comes in contact with the human body and could present any health risk falls under these requirements; or
- The foreign company interested in selling to Brazil establishes a local Brazilian manufacturing unit or local office, fully responsible for its products.
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.
Documents Required of Local Distributors for Product Registration, Importation and Sales in Brazil.
Please, contact us for a copy of this detailed report on the regulatory
system in Brazil, and the main requirements to enter the market. Please, use this
FORM.
También tenemos esto reporte en Español. Hace click AQUI para hablar con nosotros y obtener una copia.
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