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 firstname.lastname@example.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 email@example.com so that we can defer those challenges. Your health and safety are paramount to us.
Posted 14 February 2014 | By Louise Zornoza,
China's State Council Executive Committee cleared a Revised Medical Devices Bill on 12 February 2014 that modernizes China's current device law, which was first implemented more than a decade ago.
The changes include adjustments to the definition of medical devices and device classification rules; additional measures for monitoring the quality of medical device production and risk monitoring; new medical device adverse event monitoring, including traceability and recall systems; and increased penalties for violations of the law and regulations.
The process to revamp medical device regulation began in 2006 under the former State Food and Drug Administration (SFDA), which submitted the proposed revisions in 2008 to the State Council Legislative Affairs Office for its review and further modification.
Read all Breaking News from RegLink
Tags: SFDA, medical device