Market Authorization:
Registering a Medical Device

Before the medical devices can be marketed in Brazil, they must comply with Anvisa’s requirements, which vary significantly depending on the product’s risk class.

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Therefore, the first step is to determine the medical device classification. In Brazil, in accordance with RDC 751/2022, chapter II, medical devices are divided into four classes, based on their risk (Classes I, II, III and IV, from very low to very high risk). 

The market authorizations are issued by Anvisa depending on the product's risk class: Notificação (Notification) or Registro (Registration). Notificação is an abbreviated registration process and applies to class I and II medical devices. For class III to IV medical devices there is a more complex registration process, with more documents, GMP certification and often other certifications required. 

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Very similar to Annex VIII Classification rules of MDR in Europe, there are 22 classification rules determined by RDC 751/2022. Brazilian risk classes I and IV can be equivalently seen as European classes I and III, and Brazilian risk classes II and III correspond to European classes IIa and IIb, roughly.