IMDS School Singapore

Singapore 2023 Agenda

Day 1

27 - 30 March 2023 GMT+8

Venue: Temasek Polytechnic

Day 1: 27 March 2023

08:00 – 08:30 AM

Registration

08:30 – 09:00 AM

Opening Speech

09:00 – 09:45 AM

The role of Industry Associations and partners in regulatory convergence and healthcare innovation

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

09:45 – 10:30 AM

Clinical trial for Innovation in Asia

What are funding available and criteria
Single or Multi-centre trial
Plan and conduct of Clinical trial
Differences between Clinical trial vs clinical evaluation

10:30 – 10:45 AM

Tea Break

10:45 – 11:15 AM

Medtech Manufacturing Set-up or Contract manufacturing Outsourcing?

Benefit and key considerations in set-up manufacturing or outsource
Contract manufacturing vendor selection criteria

11:15 – 11:40 AM

APAC regulatory requirements - South Korea

11:40– 12:00 PM

APAC regulatory requirements - ASEAN, Greater China

12:00 – 13:00 PM

Lunch

13:00 – 13:45 PM

MDR & IVDR CE mark regulatory requirements – Introduction & Conformity assessment Routes

MDD and the New MDR, Other related Directives e.g., Combination products
Conformity assessment routes for CE Marking
Post Market: Vigilance, PMCF, PSUR
Further changes e.g., Eudamed, Clinical Evaluation
IVDD and the New IVDR
Conformity assessment routes for CE Marking
Post Market: Vigilance, PMPF, PSUR
Further changes in EU e.g., Companion diagnostic

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

US FDA regulatory requirements

510(k), PMA and other submissions

15:15 – 16:00 PM

International Medtech Opportunities for Innovation

Sharing on different type of collaboration opportunities internationally for MedTech companies

16:30 – 17:00 PM

SG Q&A & Quiz (IMDS SG)

17:00 PM

End of IMDS SG Day 1

Topics and Speakers are subjected to change