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.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.
Posted 18 November 2014 | By Stewart Eisenhart,
Content provided by Emergo Group, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide.
Brazilian medical device regulator ANVISA has begun accepting feedback from medical device companies subject to quality management inspections in order to improve and standardize inspection processes.
Firms inspected for Brazilian Good Manufacturing Practice (BGMP) compliance now have the option of submitting a form to ANVISA providing their perspective on how their quality system inspections went, and what could be improved.
For the time being, the evaluation program is meant only for investigational purposes, but does perhaps show willingness by Brazilian regulators to take more industry feedback into consideration during the BGMP inspection process over the longer term.
Learn more about Brazilian registration and BGMP compliance here.
Original Post: Emergo Group
Related Post: Brazil relaxes BGMP requirements for manufacturers holding INMETRO certification
Related Post: New Regulation in Brazil Changes Enforcement of BGMP Requirements for Certain Medical Devices
Tags: Emergo Group, Brazil, Quality Management, Brazilian GMP