Medical Product Registration is applicable to Risk Class II products and has its regulatory requirements determined by ANVISA Resolution RDC 40: 2015. The products with the lowest risk are classified in Risk Class I, and for this they require Notification with ANVISA, in accordance with the requirements of ANVISA Resolution RDC 270: 2019. The main difference is ANVISA’s form of analysis – which is simplified for Notified products.
In both cases – Notification and Registration, the organization that seeks to regularize its products must keep a Technical Dossier in its files, which is not submitted to ANVISA, and must contain evidence related to all technical product information – such as design, project, performed tests, clinical studies, among others.
Also, as for registered products, some products subject to Registration or Notification require compulsory certification – which must be provided prior to regularization with ANVISA. For Notified and Registered products no certification is required in the Good Manufacturing Practices of the manufacturing plant. All submissions are made electronically by ANVISA’s system (see details in ANVISA’s online process submissions).