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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
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The effective network of industry associations across the ASEAN, ASIA, EU, US, GLOBAL
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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
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What are funding available and criteria
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Single or Multi-centre trial
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Plan and conduct of Clinical trial
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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
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Overall regulations, directives, guidelines IMDRF, AHWP, ASEAN MDD, EU, US, Canada, Japan, Australia
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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
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Conformity assessment routes for CE Marking under MDR
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Post Market: Vigilance, PMCF, PSUR
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Further changes eg Eudamed, Clinical Evaluation
15:30 – 16:00 PM
IVDR CE mark regulatory requirements – Introduction & Conformity assessment Routes
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Conformity assessment routes for CE Marking under IVDR
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Post Market: Vigilance, PMPF, PSUR
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Further changes in EU eg Companion diagnostic
16:00 – 16:30 PM
US FDA regulatory requirements
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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