Claudia Mayer Takes a Deep Dive into Brazil ANVISA IVD Regulation RDC 830/2023 from June 1, 2024

In a webinar led by Priia and Claudia from Regdesk, they discuss Brazil's new in vitro diagnostic (IVD) regulation, effective June 1, 2023. Claudia provides an overview of the regulation's impact on diagnostic manufacturers, including compliance steps.
Key points include:
1. Regulation Overview: The new regulation, RDC 830/2023, revokes the previous RDC 36/2015 and introduces updated definitions, classifications, and transitional provisions.
2. Applicability: The regulation now includes software as a medical device and specifies exemptions for IVD devices used in clinical studies and sets of registered devices.
3. Definitions: New definitions include "accessories," "companion diagnostics," and "holder," clarifying roles and responsibilities for manufacturers.
4. Classification: IVDs are categorized into eight classification rules, with classes determined by the intended use. Some devices have been reclassified, impacting their regulatory requirements.
5. Notification and Registration: Manufacturers must demonstrate compliance with technical regulations in their registration applications, and timelines for compliance are specified.
6. Q&A Session: Attendees ask about technical assistance, exemptions, classifications, and guidance documents, with answers emphasizing that the new regulation updates previous frameworks rather than introducing entirely new rules.
The session concludes with a reminder to submit any remaining questions via email, and the PowerPoint presentation will be shared with attendees!
Stay updated with RegDesk for important regulatory information!