ANVISA Officially Extends Deadline for IVD and Cadastro Technical Dossier Requirement
Brazil’s medical device regulator ANVISA has announced official extensions for deadlines to file technical dossiers for low-risk cadastro medical devices as well as IVDs.
According to RDC 95/2016, compliance deadlines for cadastro medical devices have been pushed back two years, while deadlines for IVDs have been pushed back three years:
- Cadastro medical devices: July 28, 2018
- Cadastro and registro IVDs: July 28, 2019
As Emergo previously reported, IVDs as well as medical devices currently registered for sale in Brazil through ANVISA’s cadastro regime are now required to have technical dossiers on file; these deadline extensions allow affected manufacturers more time to ensure compliance with new requirements established by RDC 36/2015 and RDC 40/2015.