Medical devices

Publicado em 29/10/2020 16h29

What are Medical Devices?

Anvisa categorizes Medical Devices into four types: medical equipments, materials for health use, orthopedic implants and in vitro diagnostics.

Market authorizations

Market authorizations are issued by Anvisa depending on the risk classification of the medical device. Market authorizations for products categorized as Risk Class I and II do not expire, but they might be cancelled upon request, in case of reassessment, in the impossibility of solving irregularities, or when fraud is detected. Pre-market approvals for products categorized as Risk Class III and IV are valid for ten years from the date of their publication in the Brazilian Official Gazette, and may be renewed for equal and successive periods.

Please note that it is not possible for foreign companies to make administrative arrangements for issuing market authorizations directly with Anvisa. Foreign companies shall have partner companies legally constituted in Brazil that will be legally responsible for the products imported to and distributed in the Brazilian territory.

Applicable regulations

These are the main regulations applicable relating to the market authorization of medical devices exported to Brazil:

  • Medical equipments:
Resolution RDC 185/2001 and RDC 40/2015
  • Materials for health use:
Resolution RDC 185/2001 and RDC 40/2015
  • Orthopedic Implants: 

Resolution RDC 185/2001

  • In vitro diagnostics: 
Resolution RDC 36/2015 

Clinical Trials

The regulation that normalizes the submission of clinical trials with Medical Devices to Anvisa’s approval is the Resolution RDC 10/2015.