Event Listings and Information

event listings and information event listings and information
All   Music   Movies   Sports   Theater   Trade Shows   Conference Calls  

 

Japan - Regulatory Filing Requirements and Compliance Processes for Medical Devices 2017

Singapore

Monday, October 16, 2017

 

 

Course "Japan - Regulatory Filing Requirements and Compliance Processes for Medical Devices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: • Japan's classification system differs from that of the United States or European Union • Medical devices are classified to Class I, II, III, or IV depending on their risk level • Medical devices must also comply with Japanese Industrial Standards and these standards define industry-wide safety and performance requirements • Strict new package insert requirements • Change to MAH Licensing rules • A new MAH License category for In Vitro Diagnostic (IVD) devices • A new registration system for manufacturers • A new QMS conformity assessment system • New formats for pre-market certification and pre-market approval applications • Expanded scope of third party certifications • Rules for software as a medical device • Rules for transferring pre-market certifications • And Much More... Contact us today! NetZealous LLC DBA GlobalCompliancePanel john.robinson@globalcompliancepanel.com support@globalcompliancepanel.com Toll free: +1-800-447-9407 Phone: +1-510-584-9661 Website: http://www.globalcompliancepanel.com Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900988SEMINAR?wooeb-October-2017-SEO Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/ Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/ Follow us on Twitter: https://twitter.com/GCPanel

 

Add To Personal Calendar   Add to Personal Calendar

 

 

 

Post an Event - Click Here

 

 

 

 

Events By Date

Empty Image