BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//Accel - ECPv6.16.5//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-ORIGINAL-URL:https://accelgroups.com
X-WR-CALDESC:Events for Accel
REFRESH-INTERVAL;VALUE=DURATION:PT1H
X-Robots-Tag:noindex
X-PUBLISHED-TTL:PT1H
BEGIN:VTIMEZONE
TZID:America/New_York
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:20220313T070000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:20221106T060000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:20230312T070000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:20231105T060000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:20240310T070000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:20241103T060000
END:STANDARD
END:VTIMEZONE
BEGIN:VTIMEZONE
TZID:UTC
BEGIN:STANDARD
TZOFFSETFROM:+0000
TZOFFSETTO:+0000
TZNAME:UTC
DTSTART:20220101T000000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20231223T080000
DTEND;TZID=America/New_York:20231223T170000
DTSTAMP:20231018T232341Z
CREATED:20231018T231249Z
LAST-MODIFIED:20231018T232341Z
UID:241-1703318400-1703350800@accelgroups.com
SUMMARY:China Green Pathways: Expedite Your Market Entry in China
DESCRIPTION:China NMPA created several special fast-track registration channels for medical devices. To further encourage innovation\, China announced recently that approved innovative products can enjoy special pricing with higher premium enjoy reimbursement and exempt from China Volume-based Purchasing (VBP). China is the 2nd largest MedTech market and the only country with continuous double-digit growth. How can overseas companies benefit from accessing the China market faster with these special pathways? \nInnovation is one of the pre-market submission pathways with equal opportunity for both overseas and domestic manufacturers. In addition\, there are other special pathways. \nThis session will address the topics of: \n\nOverview of green pathways\nCriteria and requirements of innovation pathway\nInnovation special review dossier process\nAdvantages and consideration of fast-track channel: traditional vs. innovation pathway\nBenefit of innovative products in VBP\, pricing and reimbursement\n\nFree\n\nOnline via Microsoft Team
URL:https://accelgroups.com/event/china-green-pathways-expedite-your-market-entry-in-china/
LOCATION:China Med Device\, LLC\, United States
ATTACH;FMTTYPE=image/jpeg:https://accelgroups.com/wp-content/uploads/2023/10/nmpa-fi.jpg
ORGANIZER;CN="China Med Device%2C LLC":MAILTO:info@chinameddevice.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20231107T100000
DTEND;TZID=UTC:20231107T113000
DTSTAMP:20231101T230858Z
CREATED:20231101T230858Z
LAST-MODIFIED:20231101T230858Z
UID:1217-1699351200-1699356600@accelgroups.com
SUMMARY:Understanding IVD Reagents Registration Requirements: China & US Perspectives
DESCRIPTION:Join our webinar to stay up to date on the changing regulatory landscape in both China NMPA and US FDA for In Vitro Diagnostics (IVD) reagents. Our expert speakers will explore the key requirements\, processes\, and approval criteria for reagent products in these 2 largest Medtech markets in the world. \nAfter this 75-minute webinar you will have a practical understanding of the following areas about IVD reagents registration: \nChina NMPA \n\nGeneral regulatory landscape of IVD reagents\nSpecific IVD classification rules and registration unit division\nRegistration dossier requirements and best practices\nSignificant NMPA requirements that you need to comply for your type testing success\nUsing Overseas Clinical Trial Data for China submission\nRegulation on human genetic resources for clinical studies\n\nUS FDA \n\nFDA risk classification for IVDs\nRequirements for registration and listings of IVD products\n510K exempt devices\nConcept of general controls\nSpecial controls and pre-market approval
URL:https://accelgroups.com/event/understanding-ivd-reagents-registration-requirements-china-us-perspectives/
ORGANIZER;CN="China Med Device%2C LLC":MAILTO:info@chinameddevice.com
END:VEVENT
END:VCALENDAR