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Brazil

Medical Device Registration in 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

Documents Required: 

  • Technical Dossier
  • Labelling and IFUs
  • Clinical Data and Studies

Legalized/Notarised Documents (if any) 

Free Sales Certificate

Applicable QMS:    

ISO 13485

Registration Timeline:      

  • Class I – Notification (30 days) or 1-3 months
  • Class II – 1-3 months
  • Class III – 9-15 months
  • Class IV – 9-15 months

Authorized Representative:        

Yes. Brazilian Registration Holder (BRH)

License Validity:     

  • Class I – Notifications (Do Not Expire)
  • Class II – Registrations (Do Not Expire)
  • Class III & IV – 10 yrs

Special Notes:       

License renewals are to be initiated between 6 months – 1 year.

All documents are to be submitted in Portuguese.

Want to know more about this registration process?