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IMDS School Malaysia
Malaysia 2022 Agenda
23 - 25 March 2022 GMT+8
Online (Conducted via Zoom)
Day 3: 25 March 2022
Medical Device Regulatory, Manufacturing & Collaboration
Moderator: May Ng
08:30 – 09:00 AM
Registration
09:00 – 09:30 AM
Opening Speech
09:30 – 09:50 AM
Journey of Medical Device: R&D/Design/Manufacturing/Sterilization/Logistic/Commercial/Industry 4.0
Dr Hyzan Mohd Yusof
CEO of OSA Technologies
09:50 – 10:20 AM
MedTech International Collaboration Opportunities
Jacqueline Thacker
MedtechBOSS
10:20 – 10:50 AM
Asia Regulatory Requirements
Kelvin Koh
Arthrex
10:50 – 11:00 AM
Break
11:00 – 11:30 AM
ASEAN Medical Device Regulatory Requirements
Sasikala
ex-MDA/AHWP
11:30 – 12:00 PM
Global Regulatory Strategy & FAQs
May Ng
ARQon/MedtechBOSS
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Start-ups getting first approval: What to do?
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What is Medical Device File, Technical File, and Design History File?
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Which country first: US, EU or SG?
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Is it a must to have/certify to ISO 13485?
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Can we use Literature Paper vs Clinical Trial?
12:00 – 13:00 PM
Lunch
13:00 – 13:45 PM
Global Development and Harmonization of the Medical Device Regulations
Jack Wong
Asia Regulatory and Professionals Association (ARPA)
13:45 – 14:30 PM
Quality Management System - Importance of QMS in Design, Development, Manufacturing, Storage, Distribution (ISO13485:2016, MDSAP, USQSR, SS620 GDPMDS)
Shaun Kho
MedtechBOSS
14:30 – 15:15 PM
Supply Chain and Traceability of Medical Devices in Hospital
Andy Siow
GS1 Singapore
15:15 – 16:00 PM
MDR CE Mark Regulatory Requirements – Introduction & Conformity assessment Routes
Wu Yu Long
ECM
16:00 – 16:45 PM
US FDA Regulatory Requirements, Key Challenges in US Approval
Dr. Eamonn Hoxey
AAMI
16:45 – 17:00 PM
Quiz
17:00 PM
End of Day 3 IMDS MY