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

Event Details

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, 2017

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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...