Regulatory Filing Requirements and Compliance Processes for Medical Devices 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...

Why should you attend:

• Understand the entire Registration and Approval Process in Japan
• Identify and understand the Major Changes to Medical Device Registration Process in Japan
• Streamline the medical device registration process so that you can obtain approval for your product in the most cost-effective and timely manner
• Participants will discuss their own device registration and approval process relative to their work-related responsibilities and handling submissions
• Review and discuss pain points, challenges and solutions

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=900986SEMINAR?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