On April 8, 2024, the Brazilian National Health Surveillance Agency (Anvisa) published Normative Ruling 290/24, which establishes an abbreviated analysis process for high-risk medical devices (classes III and IV), effective as of June 3. The measure allows the process to be expedited at the request of the companies, as long as the devices have already been recognized by an equivalent foreign regulatory authority (AREE).

AREEs are foreign regulatory entities that have practices aligned with Anvisa’s and are recognized as trusted bodies. Recognition by an AREE ensures that the products authorized for commercialization have been properly evaluated and meet standards of quality, safety, and efficacy similar to Brazil.

Anvisa RDC 741/22 establishes general criteria for acceptance of analyses conducted by AREE in the sanitary surveillance at Anvisa, through an optimized analysis procedure. The resolution provides that specific rules will establish criteria and procedures to define AREEs concerning a given health surveillance process or product category.

Recognized AREEs for Medical Devices Marketing Authorization

For the adoption of the optimized procedure for analyzing medical device’s marketing authorization previously recognized by AREEs, the following entities and respective proof of registration or authorization must be considered, per Normative Ruling 220/24:

  • Austrália: Australia Therapeutic Goods Administration (TGA) – Australian Register of Therapeutic Goods (ARTG);
  • Canadá: Health Canada (HC) – Medical Device Licence;
  • Estados Unidos: US Food and Drug Administration (US FDA) – 510(k) Clearance, Premarket Approval (PMA) ou 513 (f)(2) "De Novo"; e
  • Japão: Japan Ministry of Health, Labour and Welfare (MHLW) – Pre-market approval (Shonin).

Requirements for Optimized Procedure Adoption

The optimized review procedure will be applied for medical device petitions authorized by at least one AREE from the list above.

In addition, the products intended for the Brazilian market must have the same production characteristics, indications, and intended use approved by the recognized regulatory authority, which must be demonstrated by documentation.

To apply for medical device marketing authorization via an optimized procedure, the application request must be based on the documents listed in Anvisa RDC 751/22 and Anvisa RDC 36/15, and the supplementary documentation established by the new rule:

  • Statement of Eligibility Assessment by the Optimized Analysis Procedure, which must contain company data, AREE’s reference, and product information – such as name and indication of use;
  • document proving the marketing authorization issued by the AREE; and
  • medical device instructions of use in force in the jurisdiction of the AREE.

According to the new Normative Ruling, the adoption of the optimized analysis procedure does not entail a change in the chronological order of the petitions and does not condition Anvisa's approval.

The Life Sciences & Health practice can provide more information on the topic.