We recently published here tips for grouping orthopedic implants for ANVISA registration purposes. As we highlighted in that opportunity, some rules are very specific and were subject to change.
The good news is that it didn't take long. ANVISA opened a public consultation to determine the new grouping rules for orthopedic implants for registration purposes. RDC 59/2008 and IN 01/2009 would be replaced by a new single RDC, whose proposed text can be found in the text of the public consultation.
Among the highlights of the text proposed in the public consultation are the elimination of the division of plate and screw systems into large/small and mini/micro fragments, as well as the express permission for orthopedic suture threads and suture anchors to be registered together with their inserting instruments.
Anyone who wants to view the text in its entirety and leave their opinion can access it at public consultation portal (available only in Portuguese). of ANVISA. Contributions will be accepted until 06/15/2021.
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