25 - 28 March 2025 GMT+8

Venue: Temasek Polytechnic

Day 1: 25 March 2025

MEDICAL DEVICE BUSINESS DEVELOPMENT

08:00 – 08:30 AM

Registration

08:30 – 09:00 AM

Opening & Welcome Remarks

09:00 – 09:45 AM

Global Development and Harmonization

of Medical Device Regulations

Overall regulations, directives, guidelines IMDRF, AHWP, ASEAN MDD, EU, US, Canada, Japan, Australia
Definition and risk classification of Medical Device, IVD, Drug and Combination product
Product lifecycle from research to commercialization

09:45 – 10:45 AM

ASEAN Medical Device Regulatory Requirements

Establishment registration: Manufacturer, Importer, Distributor, Authorised Representative
Product registration & other access routes

10:45 – 11:00 AM

Tea Break

11:00 – 11:45 AM

How to know who your real “customer” is, and the variety of ways to reach them

11:45 – 12:00 PM

Open discussion, and reflecting on morning topics

12:00 – 13:00 PM

Lunch

13:00 – 13:45 PM

Scaling up – How to evolve your concept into a sustainable and profitable business.

13:45– 15:00 PM

Launching your product/service to market with an intentional manufacturing & supply strategy.

15:00 – 15:15 PM

Tea Break

15:15 – 16:15 PM

OTHERS: Bringing it all together to reflect on the above and other items like funding, support, human capital (panel format)

Panel to cover off some of the themes not already covered (e.g. investment, IP, talent, government support, reimbursement)

16:15 – 17:00 PM

Open discussion or Workshop

17:00 – 18:00 PM

Wrap-up & Quiz

18:00 PM

End of Day 1

Topics and Speakers are subjected to change