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.
Updated by a group of distinguished regulatory experts, this new edition is a must-have handbook for regulatory professionals at all levels.
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.
The RAPS store will be under maintenance Saturday, 13 June between 6 AM and 12 PM EST. Store functionality may be unavailable at times during this window. We apologize for any inconvenience caused during this time.
Posted 04 December 2014 | By Louise Zornoza,
This content is provided by RegLink News, publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members.
India’s Central Drugs Standard Control Organization (CDSCO) is seeking input on draft revisions to Schedule M-III of the country’s Drug and Cosmetic Act, which describes good manufacturing practices (GMPs) for medical devices.
The revisions aim to bring the GMP requirements for medical devices and in-vitro diagnostics into alignment with international GMP standards. They require that the quality system for the manufacture of devices and IVDs conform to the BIS 15579/ISO 13485 international standard, an internationally recognized quality standard which states the requirements of the quality management system for the design and manufacture of medical devices.
For combination devices, the manufacturing process for the drug/biologics must conform to the GMP requirements set out in Schedule M of India’s Drug and Cosmetic Act governing pharmaceutical GMPs, but the process of loading the drug/biologics into the device and thereafter will be governed by the proposed device/IVD GMP standards.
The deadline for comments on the draft GMPs is 17 December 2014.
Tags: Reglink, Schedule M-III, GMP, ISO 13485
Regulatory Focus newsletters
All the biggest regulatory news and happenings.