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IMDS School Singapore

Korea 2023 Agenda 

27 March 2023

Venue: Korea

Day 1: 27 March 2023 (KST )

09:00 – 09:30 AM

Registration

09:30 – 10:00 AM

Opening Speech

10:00 – 10:45 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

10:45 – 11:30 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

11:30 – 11:45 AM

Tea Break

11:45 – 12:15 PM

Medtech Manufacturing Set-up or Contract manufacturing Outsourcing?

  • Benefit and key considerations in set-up manufacturing or outsource

  • Contract manufacturing vendor selection criteria

12:15 – 12:40 PM

APAC regulatory requirements -  South Korea

12:40– 13:00 PM

APAC regulatory requirements - ASEAN, Greater China

13:00 – 14:00 PM

Lunch

14:00 – 14:45 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

14:45 - 15:00 PM

Korea Q&A (End of IMDS KR)

Topics and Speakers are subjected to change

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