Products under ANVISA’s regulation:

  • Medical Devices includes a wide range of products such as prosthesis to wheel chairs.
  • Drugs – include all kind of medication products.
  • Cosmetics – perfumes; facial creams; toothpaste and brushes; body, lips, eyes and skin creams; products for: hair, nails, etc.; products for external genital organs, mucous membranes; etc.
  • Sanitizing – any cleaning substance for home and professional.
  • Food – all the food special supplements, such as athletic and others.
  • In Vitro Diagnosis – products for testing procedures in Labs.

 

Information:

  • Product registration must be requested ONLY by a company duly authorized by ANVISA.
  • The Company will hold the register for 5 years ;
  • Average time to register products after requesting registration at ANVISA, depends on the type of product  and risk class*.
  • This is a similar procedure of the FDA (Food and Drug Administration – USA).

 

* The FDA and CE classification of products differs from the ANVISA. For example: The medical products in Brazil are classified according to the  risk class according to RDC 185/2001 (Class I, II, III and IV)