Updates in Medical Device Regulation!
Today, on December 11, 2023, RDC 830/2023 was published in the Official Gazette, introducing significant changes. It will revoke RDC 36/2015 and modify Normative Instruction No. 3, dated August 26, 2015, as soon as it comes into effect.
Essentially, this new RDC consolidates and updates aspects related to risk classification, notification and registration regimes, along with labeling requirements and usage instructions for in vitro diagnostic medical devices and their instruments. Important note: It will only come into effect starting from June 1, 2024.
🔍 Check out the English translation firsthand in the attachment!
⏳ Stay tuned! Tomorrow, our team of experts will present a detailed analysis of this new regulation. Send an email to contactBR@brisa.com.br to receive the Gap analysis firsthand!
📌 Comment below if you have any considerations about this announcement!
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