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.


Click here to contact us

How does ANVISA Product Regulation work?

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 State Operating License and in many cases, Federal Operating Authorization 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.

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

  • Cosmetics
  • Personal hygiene products
  • Perfume

Sanitizers and Household Products

  • Sanitizers
  • Household Products

Food

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

Contact us

Pick your favorite way to be attended?

   

I consent to the use of my data in accordance with the Privacy Policy, which I declare that I have read and understood.

You may also like