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.
The Learning Portal will be under maintenance Monday, 6 December between 6 AM and 5 PM EST. Portal functionality will be unavailable during this window. We apologize for any inconvenience caused during this time.
Posted 01 July 2013 | By Ansis Helmanis,
The China Food and Drug Administration (CFDA) has issued a notice regarding adjustments to the duties undertaken by provincial food and drug supervision and management departments, part of an effort to implement the State Council institutional reform and functional transformation plan to further the reform of administrative evaluation and approval of medical devices.
The notice points out that as of 1 October 2013, the provincial Food and Drug Administration departments must implement Class III medical device registration certificate approvals and approval of in vitro diagnostic reagents.
As of 1 July 2013, the provincial Food and Drug Administration departments will undertake the quality management system inspection work originally conducted by the State Food and Drug Administration Drug Certification Management Centre for Class III medical devices and in vitro diagnostic reagents.
CFDA Notice
Read all Breaking News from RegLink
Tags: IVD, Class III, approval, medical device
Regulatory Focus newsletters
All the biggest regulatory news and happenings.