18 - 21 March 2024 GMT+8

Venue: Temasek Polytechnic

Day 1: 18 March 2024

08:00 – 08:15 AM

Registration

08:15 – 08:30 AM

Opening & Welcome Remarks

08:30 – 09:15 AM

Role of Trade Associations – Driving access, innovation & collaboration

The effective network of industry associations across the ASEAN, ASIA, EU, US, GLOBAL
The importance of association’s role for its stakeholders i.e. local industry and the national authorities/agencies

09:15 – 09:40 AM

EU Regulatory Requirements & Strategy

09:40 – 10:05 AM

US Regulatory Requirements & Strategy

10:05 – 10:30 AM

Innovation vs Regulation: Friend or Foe?

10:30 – 10:45 AM

Tea Break

10:45 – 11:15 AM

Medical software – Regulation & Strategy

11:15 – 11:40 AM

Use of Real-World Evidence for regulatory approval in Korea

11:40– 12:00 PM

Medical Device reimbursement in Korea – A MedTech company’s worst nightmare?

12:00 – 13:00 PM

Lunch

13:00 – 13:45 PM

Clinical Investigation for the registration of Medical Devices in Korea

13:45 – 14:30 PM

Global Harmonization of the medical device regulations

Overall regulations, directives, guidelines IMDRF, AHWP, ASEAN MDD, EU, US, Canada, Japan, Australia
Definition and Risk classification of Medical Device, IVD, and Combination product

14:30 – 14:45 PM

Tea Break

14:45 – 15:15 PM

MedTech in Korea – Where is it heading?

15:15 – 15:45 PM

The Startup Journey – From Concept to Commercialization and Adoption

15:45 – 16:15 PM

Startup Funding – Tips for landing it

16:15 PM

End of IMDS SG Day 1

Topics and Speakers are subjected to change