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.
- 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)|