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

Event Details

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

Time: October 16, 2017 at 9am to October 17, 2017 at 6pm
Location: Singapore
Street: Mandarin Orchard Singapore
City/Town: Singapore
Website or Map: http://www.globalcompliancepa…
Phone: 800-447-9407
Event Type: online, healthcare, training, courses
Organized By: NetZealous DBA as GlobalCompliancePanel
Latest Activity: Aug 31

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Event Description

 

 

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?medtechiq-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

 

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