As announced last week, ANVISA, at the DICOL meeting, unanimously approved the process of optimized analysis of medical device registration petitions based on analyzes previously carried out by Equivalent Health Authorities.
Today (April 8) Normative Instruction No. 290, dated April 4, 2024, was published, with procedures for using analyzes and procedures. Find the legislation for download on our blog at the link below.
We will soon have a post with our insights into this new regulation.