Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 24 January 2013 | By Louise Zornoza,
The Board of Brazil's national regulatory agency, Anvisa, has abandoned a draft resolution that proposed how the regulatory agency would conduct overseas current good manufacturing practice (CGMP) inspections at medical device and in vitro diagnostic (IVD) manufacturing sites.
Regulators cited comments indicating that the high cost of the inspections would outweigh the benefits of the proposal for the withdrawal of the draft resolution.
Moreover, elements of the earlier proposal are now covered by the recently launched Public Consultation 02/2013 on the conditions for granting Certificates of GMP and Good Distribution Practice (GDP) and Storage.
Read all Breaking News from RegLink
Tags: Board, Latest News, brazil, cGMP, IVD, inspections, medical device