The RAPS learning platform provider will be upgrading its security posture. This will take the system off-line from 20 July through the end of the day 23 July. This will affect any Online Course, eBook, and Virtual Program Attendance. Thank you for your patience.
Brazil Expedites Device Imports
Posted 15 April 2014 | By
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 manufacturing site awaits CBPF certification. Moreover, lower risk devices, such as gloves, syringes and some surgical instruments, will no longer require CBPF certification prior to import, which will eliminate about 25% of the CBPF certification applications received by the agency.
Read all Breaking News from RegLink