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.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Resources, news and special offers to support you and your professional development during this difficult time.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
With so many global regulation changes, staying informed is a challenge. Join other regulatory professionals as you navigate the gray together.
Learn how recent changes to the regulation of healthcare products in the EU will impact you as a regulatory professional.
In light of the COVID-19 pandemic, the RAC Board has elected to offer online testing with live online proctoring this summer.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
Posted 10 June 2015 | By Stewart Eisenhart,
Content provided by Emergo, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide.
Brazilian medical device market regulator ANVISA has officially extended deadlines for market applicants to respond to technical inquiries regarding their registration submissions.
ANVISA’s technical requirement response deadline, previously 90 days, has been extended to 120 days from confirmation of requirement receipt by applicants. The new deadline is included in RDC 23/2015 (link in Portuguese), which amends some articles of RDC 204/2005 concerning submission procedures for medical device registrants.
Brazilian medical device registrants currently under technical review will automatically have their response deadlines extended from 90 to 120 days, as well.
Extended technical response timeframes mean applicants will have more time to provide adequate responses to ANVISA inquiries and avoid having to restart their application efforts (and pay additional submission fees) due to missed deadlines.
Original Post on Emergo's Blog
Related Post: Brazil relaxes BGMP requirements for manufacturers holding INMETRO certification
Related Post: INMETRO Certification Changes in Brazil
Tags: Emergo, Emergo Group, Brazil
Regulatory Focus newsletters
All the biggest regulatory news and happenings.