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IMDS School Singapore

Korea 2023 Agenda 

27 March 2023

Venue: Korea

Day 1: 27 March 2023

MEDICAL DEVICE REGULATORY

Moderator: May Ng

08:30 – 09:00 AM

Registration

09:00 – 09:15 AM

Opening Speech

09:15 – 10:15 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

10:45 – 11:00 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

10:45 – 11:00 AM

Tea Break

11:00 – 11:45 PM

International Medtech Opportunities for Innovation

11:45 – 12:15 PM

Medtech Manufacturing Set-up or Contract manufacturing Outsourcing?

12:15 – 13:15 PM

Lunch

13:15 – 13:45 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

13:45 – 14:15 PM

APAC regulatory requirements -  South Korea

14:15 – 14:45 PM

APAC regulatory requirements - ASEAN, Greater China

14:45 – 15:00 PM

Tea Break

 

15:00 – 15:30 PM

MDR CE mark regulatory requirements – Introduction & Conformity assessment Routes

  • Conformity assessment routes for CE Marking under MDR

  • Post Market: Vigilance, PMCF, PSUR

  • Further changes eg Eudamed, Clinical Evaluation

15:30 – 16:00 PM

IVDR CE mark regulatory requirements – Introduction & Conformity assessment Routes

  • Conformity assessment routes for CE Marking under IVDR

  • Post Market: Vigilance, PMPF, PSUR

  • Further changes in EU eg Companion diagnostic

16:00 – 16:30 PM

US FDA regulatory requirements

  • 510(k), PMA and other submissions

16:30 – 17:00 PM

Q&A (IMDS KR) & Quiz (IMDS SG)

17:00 PM

End of Day 1 IMDS SG

Topics and Speakers are subjected to change

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