BEGIN:VCALENDAR PRODID:NingEventWidget-v1 VERSION:2.0 METHOD:PUBLISH BEGIN:VTIMEZONE TZID:America/New_York X-LIC-LOCATION:America/New_York BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:19700308T020000 RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:19701101T020000 RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU END:STANDARD END:VTIMEZONE BEGIN:VEVENT UID:2140535:Event:75134 DTSTAMP:20260913T010713Z SUMMARY:Regulatory Filing Requirements and Compliance Processes for Me dical Devices 2017 DESCRIPTION: \n \nCourse \"Japan - Regulatory Filing Requirements an d 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.\n \nOverview:\n \n\nJapan's cl assification system differs from that of the United States or European Union\nMedical devices are classified to Class I, II, III, or IV depe nding on their risk level\nMedical devices must also comply with Japan ese Industrial Standards and these standards define industry-wide safe ty and performance requirements\nStrict new package insert requirement s\nChange to MAH Licensing rules\nA new MAH License category for In Vi tro Diagnostic (IVD) devices\nA new registration system for manufactur ers\nA new QMS conformity assessment system\nNew formats for pre-marke t certification and pre-market approval applications\nExpanded scope o f third party certifications\nRules for software as a medical device\n Rules for transferring pre-market certifications\nAnd Much More...\n\n  \nWhy should you attend:\n \n\nUnderstand the entire Registration a nd Approval Process in Japan\nIdentify and understand the Major Change s to Medical Device Registration Process in Japan\nStreamline the medi cal device registration process so that you can obtain approval for yo ur product in the most cost-effective and timely manner\nParticipants will discuss their own device registration and approval process relati ve to their work-related responsibilities and handling submissions\nRe view and discuss pain points, challenges and solutions\n\n\n \nContac t us today!\n \nNetZealous LLC DBA GlobalCompliancePanel\njohn.robins on@globalcompliancepanel.com  \nsupport@globalcompliancepanel.com \ nToll free: +1-800-447-9407\nPhone: +1-510-584-9661\n Website: http:/ /www.globalcompliancepanel.com\n \nRegistration Link - http://www.glo balcompliancepanel.com/control/globalseminars/~product_id=900986SEMINA R?medtechiq-October-2017-SEO\n \nFollow us on LinkedIn: https://www.l inkedin.com/company/globalcompliancepanel/\nLike us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/\nFollow us on Twitter: https://twitter.com/GCPanel\n \n \n\nFor more informati on visit https://medtechiq.ning.com/events/regulatory-filing-requireme nts-and-compliance-processes-for DTSTART;TZID=America/New_York:20171012T090000 DTEND;TZID=America/New_York:20171013T180000 CATEGORIES:online, healthcare, training, courses LOCATION:Zurich, Switzerland WEBSITE:http://www.globalcompliancepanel.com/control/globalseminars/~p roduct_id=900986SEMINAR?medtechiq-October-2017-SEO URL:http://www.globalcompliancepanel.com/control/globalseminars/~produ ct_id=900986SEMINAR?medtechiq-October-2017-SEO CONTACT:800-447-9407 ORGANIZER:NetZealous DBA as GlobalCompliancePanel ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/ file/get/2562015610?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob inson":https://medtechiq.ning.com/profile/JohnRobinson END:VEVENT END:VCALENDAR