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ANVISA Product Regulation

ANVISA Product Regulation ANVISA Product Regulation

RAGB simplifies the entire ANVISA Product Regulation process, advising your company at all stages, leading to final approval of the product. We compile all the required documentation (tests, reports, analysis, research, certification), and develop dossiers that include usage instructions, labeling, and technical reports. We also assist the company should there be any compliance issues, or requirements by government authorities, throughout the procedure.

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How does ANVISA Product Regulation work?

ANVISA distinguishes regulated products by risk classes ranging from I to IV. Usually, class I products undergo not registration, but rather product listing. Other classes, however, are required to be regulated by ANVISA.

In order to start the product normalization process, a Local Operating License and the Operating Permit are necessary. For companies with products in classes III and IV, a Good Manufacturing Practice Certificate is mandatory.

RAGB handles the product registration process and also provides advisory and consultancy services for the acquisition of licenses and company authorization, further facilitating the ANVISA regulatory processes.

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Our Advantage

RAGB professionals are up-to-date on legislation, which changes frequently, and can assist companies with all their activities in the healthcare sector in order to regulate their products.

Some of the activities regulated by ANVISA:

Health and Health-related Products

Health products
Health equipment
In vitro diagnosis

Cosmetics, Beauty and Esthetics
Personal hygiene products

Sanitizers and Household Products


Household Products


New foods
Food claiming to have functional and/or health properties


Original (An original drug has a unique formula, which means there are no similar drugs in national and international markets. It is a unique drug aimed at treating a specific pathology. In Brazil they are also referred to as “Reference Drugs”.)

Similar (Similar drugs are identified by a trade or brand name and have the same molecule (active principle), pharmaceutical form and route of administration of reference drugs.)

Generic (Generic drugs have the same active principle of a reference drug and are usually produced after the patent protection and other exclusivity rights have expired or revoked. Generic drugs may replace reference drugs, if prescribed by a physician.)

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