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

  • Start-ups getting first approval: What to do?

  • What is Medical Device File, Technical File, and Design History File? 

  • Which country first: US, EU or SG?

  • Is it a must to have/certify to ISO 13485?

  • 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

Topics and Speakers are subjected to change