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Anvisa’s New Optimized Procedure for Medical Device Registration

The National Sanitary Vigilance Agency (Anvisa) has just announced a new optimized procedure for analyzing and deciding on applications for registration of medical devices and in vitro diagnostic devices. The announcement came via Normative Instruction – IN 290/2024, which comes into force on June 3, 2024. This is a major change that promises to speed up the process of registering health products in Brazil, this brings benefits to both manufacturers and patients.

What is the Optimized Procedure?

The optimized procedure applies to high and maximum risk medical devices and in vitro diagnostic devices (Classes III and IV). To adopt the optimized procedure, the product must have prior authorization (proof of authorization/registration) from a recognized Equivalent Foreign Regulatory Authority (in Portuguese, “Autoridade Reguladora Estrangeira Equivalente – AREE“) and be essentially identical to the one approved by the AREE.

What are the recognized AREEs and their required evidence?

  • Australia: Australia Therapeutic Goods Administration (TGA) – Australian Register of Therapeutic Goods (ARTG);  

  • Canada: Health Canada (HC) – Medical Device License 

  • United States of America (USA): US Food and Drug Administration (US FDA) – 510(k) Clearance, Premarket Approval (PMA) or 513(f)(2) “De Novo”; 

  • Japan: Japan Ministry of Health, Labor and Welfare (MHLW) – Premarket approval (Shonin). 

Definition of Medical Devices: In Vitro Diagnostic Medical Devices

The recognized AREEs are all internationally renowned regulatory authorities, known for their rigorous safety and efficacy standards. The proof of registration or authorization issued by the authority that must refer to the medical device. 

 

It is worth noting that having the device registered in the country from one of the AREEs established by ANVISA does not exclude submission in accordance with RDC’s 751/2022 or 830/2023 and their updates. 

Access IN 290/2024 in full (Portuguese version), click the button below:

ACCESS IN 290 IN THE OFFICIAL GAZETTE

Stay tuned for more updates on this and other important health topics. If you would like to find out more about Passarini Group’s solutions for the healthcare sector, please contact us and request a quote. We’ll be available to assist you, simply contact us by email at:[email protected].

Passarini Group

Published on: 06/27/2024

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