RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Brazil Expedites Device Imports

    Brazil's national regulatory agency, Anvisa, has expedited the process for importing high-risk medical devices (Class III and IV) by agreeing to review devices as soon as its foreign manufacturing site is granted a Certificate of Good Manufacturing Practices (CBPF) by a foreign regulator.  Under the revised procedure (RDC 15/2014), new high tech devices should enter the Brazilian market sooner, since the analysis of the device by the agency can proceed while the ...
  • Brazil: New Agreement Paves Way for Manufacturing Facilities to Produce Multiple Drug Types

    Based on a 7 May agreement between Brazil's National Health Surveillance Agency (ANVISA) and the Ministry of Agriculture, Livestock and Supply (MAPA), companies will be allowed to produce drugs for both veterinary and human use in the same manufacturing facility as long as the active ingredients and excipients have been approved for both human and veterinary use. Companies wishing to take advantage of this new approach will be required to obtain Certificates of Good Ma...