Medical Device Registration in
Ministry of Health:
Ministerio da Saude (Ministry of Health)
(The Brazilian Health Regulatory Agency)
Medical Device Regulation:
Resolution – RDC No. 102 (Aug. 24, 2016)
Class I, II, III and IV
- 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
- Technical Dossier
- Labelling and IFUs
- Clinical Data and Studies
Legalized/Notarised Documents (if any)
Free Sales Certificate
- Class I – Notification (30 days) or 1-3 months
- Class II – 1-3 months
- Class III – 9-15 months
- Class IV – 9-15 months
Yes. Brazilian Registration Holder (BRH)
- Class I – Notifications (Do Not Expire)
- Class II – Registrations (Do Not Expire)
- Class III & IV – 10 yrs
License renewals are to be initiated between 6 months – 1 year.
All documents are to be submitted in Portuguese.