ANVISA Unveils Ambitious Overhaul Plans for Medical Device Regulations

Medical device market regulators in Brazil are planning several updates and revisions to their existing regulatory system through late 2014 that could affect nearly all major registration and quality management system requirements in the country, Emergo Group has learned.

Brazilian medical device regulator ANVISA has drawn up a list of medical device and in vitro diagnostic (IVD) issues targeted for revision:

  • New regulatory requirements specifically for medical device software
  • Modification of RDC 25/2009 regarding which classes of devices require Brazil Good Manufacturing Practice (BGMP) quality system certification
  • Updated grouping and classification criteria for IVD products
  • Updated regulations for orthopedic implant devices
  • Updated regulations for transfers of registration ownership

None of these revisions has yet occurred, however, and there’s no guarantee ANVISA will implement all of its planned changes by the end of 2014. Still, the regulator’s announcement illustrates which areas of the Brazilian medical device and IVD registration system ANVISA would most likely revise in the near future. Clearer registration pathways for IVD and software products as well as more streamlined BGMP requirements, if enacted, could lead to more efficient and cost-effective market access for foreign manufacturers.

Stewart Eisenhart

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