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.
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.
For 20 years, our flagship publication, Fundamentals of US Regulatory Affairs, has been giving regulatory professionals the insights and answers they need, right at their fingertips.
There are hundreds of RAC testing centers available worldwide. Any of the four RAC exams (US, EU, CAN or Global) may be taken at any location. Find an upcoming exam at a location near you.
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.
The RAPS store will be under maintenance Saturday, 7 December between 6 AM and 12 PM. Store functionality may be unavailable at times during this window. We apologize for any inconvenience caused during this time.
Posted 01 May 2012 | By Alexander Gaffney, RAC
The Asian Harmonization Working Party (AHWP) has announced it has been accepted as a member in both the International Medical Devices Regulators Forum (IMDRF) and the International Standards Organization (ISO).
AHWP is a non-profit dedicated to the harmonization of medical device regulations, and includes among its members China, India, Saudi Arabia, Korea, South Africa and Pakistan.
The organization said IMDRF had extended an invitation for AHWP to join its Forum as an affiliated organization and to act as an official observer on its Management Committee, which it accepted on 30 April.
"We look forward to working with IMDRF to enhance medical devices regulatory harmonization, accelerate international convergence, and achieve alignments of IMDRF and AHWP harmonization efforts," said AHWP in a statement posted on its website.
The group also announced its petition to join ISO's Technical Committee 210, ISO's quality management committee for medical devices, had been accepted. AHWP said in a statement it looked forward to assisting ISO on the "standardization of requirements and guidance in the field of quality management."
Read more:
AHWP's Participation in ISO / TC 210
AHWP's Participation in the International Medical Device Regulators Forum (IMDRF)
Tags: Member, Inclusion, Join, AHWP, Latest News, membership, medical device
Regulatory Focus newsletters
All the biggest regulatory news and happenings.