Brazil

Ministry of Health: 

Ministerio da Saude (Ministry of Health)

Regulatory Authority:       

Agencia Nacional de Vigilancia Sanitaria (ANVISA)

(The Brazilian Health Regulatory Agency)

Medical Device Regulation:

Resolution – RDC No. 102 (Aug. 24, 2016)

Official Language:   

Portuguese

Classification:        

Class I, II, III and IV

Registration Process:       

• Determine the classification of the medical device.
  • Class I and II – Cadastro Registration Pathway
  • Class III and IV – Registro Pathway
• Provide LoA to BRH, who submits the registration application to ANVISA.
• Payment of application fees
• For Class I, ANVISA issues Notification Number
• For Class II-IV, ANVISA publishes the registration number in Diario Oficial da Uniao (DOU)
• Appoint a qualified importer/distributor to bring the device into Brazil.
• The manufacturer may now begin marketing the device in Brazil