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KIMES Seminar
3/23(Thur)
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1CE MDR Regulation
[Speaker] DNV / SOO HYUK UHM / Lead Auditor
- [Date] 3.23(Thur) (09:30~12:00)
- [Organizer] Korea Medical Devices Industrial Cooperation Association
- [Venue] Rm. 317
- [Contact] +82-70-4837-5579
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CE MDR Regulation [Speaker] BSI Group | Michael Weissig | Managing Director [Time] 14:00~18:00
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2Person Responsible for Regulatory Compliance(PRRC)
[Speaker] DNV GL / Jung, In Sung / Lead Auditor
- [Date] 3.23(Thur) (09:30~18:00)
- [Organizer] Korea Medical Devices Industrial Cooperation Association
- [Venue] Rm. 317
- [Contact] +82-70-4837-5579
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3Vietnam · Indonesia Medical Devices Market Seminar
[Speaker] KMDICA / Shin, Sung Ho, Kim, Young Seob / Managing Director
- [Date] 3.23(Thur) (10:00~12:00)
- [Organizer] Korea Medical Devices Industrial Cooperation Association
- [Venue] Rm. 320
- [Contact] 070-8892-3740
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4Current Medical Virtual Reality
[Speaker] Yonsei University College of Medicine Young Joon Seo Chief
- [Date] 3.23(Thur) (10:00~12:00)
- [Organizer] Korea Medical Devices Industrial Cooperation Association
- [Venue] Rm. 321
- [Contact] 070-8892-3743
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5Understanding of Listing Treatment Materials Insurance Benefits
[Speaker] Health Insurance Review & Assessment Service / Kim, Ji Hye / Kim, Su Jin / Managing Director
- [Date] 3.23(Thur) (13:00~15:00)
- [Organizer] Korea Medical Devices Industrial Cooperation Association
- [Venue] Rm. 321
- [Contact] +82-70-4837-5564
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6Medical device Product Environmental Regulatory Response seminar
[Speaker] KOTITI Testing & Research Institute / Jung Hyun, Lee / General manager
- [Date] 3.23(Thur) (09:00~12:00)
- [Organizer] Korea Medical Devices Industrial Cooperation Association
- [Venue] Rm. 327
- [Contact] +82-70-8892-3833
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7European Certification Correspondence Seminar
[Speaker] Eurofins MET Korea / Steve, Min / Medical Device Team Manager
- [Date] 3.23(Thur) (13:00~18:00)
- [Organizer] Korea Medical Devices Industrial Cooperation Association
- [Venue] Rm. 327
- [Contact] +82-70-4837-5053
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8Digitalization of Korean medical industry
- [Date] 3.23(Thur) (10:05~11:25)
- [Organizer] KMDIA
- [Venue] Rm. 307
- [Contact] +82-2-596-0460
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Smart Hospital Project in Korea [Speaker] Korea Health Industry Development Institute / Yim, Yeong Yi / Director, Department of Healthcare Service innovation [Time] 10:05~10:25 Samsung Medical Center Announces HIMSS DIAM 7 Certification Case [Speaker] SMC / Lee JeanHyoung / Manager of IT Infrastructure Part [Time] 10:25~10:45 Enterprise Imaing Strategies and Challenges for Digital Transformation [Speaker] INFINITT Healthcare / Douglas Kim / CEO [Time] 10:45~11:05 Blueprint of Future Clinical Workflow with A.I [Speaker] Lunit, Inc. / Chanick Park / VP of Marketing [Time] 11:05~11:25
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9의료기기 수입요건 및 광고심의 민원설명회
- [Date] 3.23(Thur) (14:00~17:00)
- [Organizer] KMDIA
- [Venue] Rm. 307
- [Contact] +82-70-7725-0669
Medical device advertising review regulation & review criteria | [Speaker] KMDIA / Lee Ji Yeon, Lee Shin Ae / Manager | [Time] 14:00~15:00 |
Medical Device HS Code and item classification | [Speaker] CVNCI / Song Yeong Min / Team Leader | [Time] 15:00~16:00 |
Stable using support plan of Humanitarian or Emergency Use Medical Devices and self-use Medical device - Application process by using UNI-PASS system - |
[Speaker] NIDS LEE Hyo Seok Team Leader | [Time] 16:00~16:30 |
Introduction on Requirement for Exemption from imported medical device | [Speaker] KMDIA / CHO EUN BI / Team Leader | [Time] 16:30~17:00 |
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102023 MDR Presentation of the CE marking certification and Strategy
[Speaker] QTICS Group Csaba Sántics Expert
- [Date] 3.23(Thur) (10:00~12:00)
- [Organizer] QTICS Group
- [Venue] Rm. 402
- [Contact] +82-10-3421-3772
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11EU Regulatory MDD -> MDR
- [Date] 3.23(Thur) (14:00~17:00)
- [Organizer] DreamCIS
- [Venue] Rm. 402
- [Contact] woo-rim.ahn@tigermedgrp.com
EU Regulatory MDD-> MDR - What to prepare? | [Time] 14:00~17:00 | |
Dermal Filter: What to Prepare? MDD -> MDR | [Time] 14:00~17:00 | |
Key Benefit for MDR Clinical Trial in Eastern Europe | [Time] 14:00~17:00 |
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12US Medical Device Market Entry Strategy
- [Date] 3.23(Thur) (10:00~13:00)
- [Organizer] KMDIA
- [Hosted] U.S. Embassy Seoul
- [Venue] Rm. 403
- [Contact] +82-70-7725-8136
Congratulatory Remarks | [Speaker] KMDIA Cheolwook Yoo Chairman | [Time] 10:00~10:05 | |
Welcoming Remarks | [Speaker] U.S. Embassy Seoul Gregory Briscoe Minister Counselor for Commercial Affairs | [Time] 10:05~10:10 | |
US Medical Device Market Overview | [Speaker] AdvaMed Joseph Gatewood / Vice President, Global Strategy | [Time] 10:10~10:30 | |
Select USA | [Speaker] U.S. Embassy Seoul / Heesook Baik / Commercial Specialist | [Time] 10:30~10:50 | |
Entering the U.S. Healthcare Market: Strategies for Funding, FDA Approval and Clinical Trials | [Speaker] CSSi / Ernesto Chanona / Vice President | ![]() |
[Time] 11:00~12:00 |
Recent FDA News and Examples of Foreign Medical Device Companies that Entered the US Market | [Speaker] Globizz / Takahiro Haruyama / President | [Time] 12:00~13:00 |
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13Australian Innovative Medtech Seminar
- [Date] 3.23(Thur) (13:30~16:00)
- [Organizer] KMDIA
- [Hosted] Australian Trade and Investment Commission
- [Venue] Rm. 403
- [Contact] +82-70-7725-8136
Opening Ceremony | [Speaker] KMDIA / Cheolwook Yoo / Chairman | [Time] 13:30~13:35 | |
Congratulatory Remark | [Speaker] Austrade / Julie Quinn / Senior Trade and Investment Commissioner | ![]() |
[Time] 13:35~13:45 |
Australian Medtech Regulatory and Trends | [Speaker] MTAA / Dr Jasjit Baveja / Associate | [Time] 13:45~14:00 | |
‘Accelerating collaboration in biomedical engineering research’ | [Speaker] Aikenhead Centre for Medical Discovery | Dr. Erol Harvey | Head of Development and Research Translation | [Time] 14:00~14:15 | |
‘Current Australian developments in prediction and treatment of seizures’ | [Speaker] Biomedical Engineering,University of Melbourne | Mark Cook | Professor | [Time] 14:15~14:30 | |
Conducting clinical trials in Australia | [Speaker] Mobius Medical Pty Ltd | Stefan Czyniewski | Principal & Clinical Director | [Time] 14:30~14:45 | |
Australian innovation in medtech design | [Speaker] Design+Industry | Adam Donath | Business Development, Medical Programs Lead | [Time] 14:45~15:00 | |
Accessing the Australian government R&D tax incentives | [Speaker] Acclime Australia | Katusha Roca | R&D Director | [Time] 15:00~15:15 | |
Case Study: Delivering AI Enabled National Breast Screening in Australia | [Speaker] Lunit / Janice Jung / VP of Business Development | [Time] 15:15~15:30 | |
Case Study: Wellysis Medtech Start-up Entering the Australian Market | [Speaker] Wellysis / Young Juhn / CEO | [Time] 15:30~15:45 | |
Q&A / Networking | [Time] 15:45~16:00 |
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14Entire Cycle of Entering the Medical Device Market Seminar
- [Date] 3.23(Thur) (13:35~16:50)
- [Organizer] Korea Health Industry Development Institute
- [Venue] 300호
- [Contact] tyhawk@khidi.or.kr
One-Stop Service Center for Medical Device Industry | [Speaker] KHIDI Tae-young Jung Researcher | ![]() |
[Time] 13:35~13:50 |
Medical Device International Regulation Support Center | [Speaker] WMIT James Kim Vice President | ![]() |
[Time] 13:50~14:05 |
Medical Device Approval Process | [Speaker] MFDS Chanhoi Hur Senior Scientific Officer | ![]() |
[Time] 14:05~14:45 |
Innovative medical device system and support policy | [Speaker] MFDS Seon-mi Lee Deputy Director | ![]() |
[Time] 14:45~15:00 |
Integrated Examination/Evaluation System for Innovative Medical Devices | [Speaker] KHIDI Kwon-ho Kim Researcher | ![]() |
[Time] 15:00~15:15 |
Health insurance registration procedure (Medical Technology) | [Speaker] HIRA Ji Hye Kim Deputy Division Director | ![]() |
[Time] 15:30~15:50 |
Health insurance registration procedure (Medical Device) | [Speaker] HIRA SU JIN KIM Deputy Division Director | ![]() |
[Time] 15:50~16:10 |
New medical technology evaluation process (Medical Supply) | [Speaker] NECA Wonjung Choi Research Fellow | ![]() |
[Time] 16:10~16:50 |
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15YONSEI Innovative Medical Device Evaluation and Development Center Performance Report Event
- [Date] 3.23(Thur) (14:00~17:00)
- [Organizer] YONSEI Innovative Medical Device Evaluation and Development Center
- [Venue] Rm. 301
- [Contact] +82-2-2019-5464
YONSEI Innovative Medical Device Evaluation and Development Center Introduction | [Speaker] YONSEI Innovative Medical Device Evaluation and Development Center / Kuh Sung Uk / Director | ![]() |
[Time] 14:00~14:50 |
performance case 1 | [Speaker] VUNO / Yim Jae Jun / Managing Director | ![]() | [Time] 15:00~15:20 |
performance case 2 | [Speaker] LIVSMED Inc. / Bae Dong Hwan / CSO | ![]() |
[Time] 15:20~15:40 |
의료기기산업종합지원계획 | [Speaker] Korea Health Industry Development Institute / Lee Jin Su / Team manager | ![]() |
[Time] 15:50~16:20 |
Gangnam Severance Hospital Medical Device Usability Research Center Introduction | [Speaker] Gangnam Severance Hospital Medical Device Usability Research Center / Jang Won Seuk / Director |
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[Time] 16:30~17:00 |
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17국산 의료기기 글로벌 선점을 위한 병원-기업의 역할
- [Date] 3.23(Thur) (10:00~16:00)
- [Organizer] 스마트의료기기 상생포럼,한국스마트의료기기산업진흥재단
- [Venue] 308호
- [Contact] +82-2-6347-5101
개회사 | [Speaker] 이규성 회장 | [Time] 10:00~10:10 | |
스마트의료기기 산업의 글로벌화 전략 | [Speaker] MeDiF 허영 부이사장 | [Time] 10:00~10:40 | |
제1부 : 국내 혁신 스마트의료기기 기업 소개 | |||
Openning the Era of Digital Twin : MEDICAL IP | [Speaker] 메디컬아이피(주) 이혁희 전무 | ![]() |
[Time] 10:40~11:00 |
의료영상 AI 기기의 글로벌 이슈선점: Trustworthy AI의 보증 선도 모델 | [Speaker] 클라리파이 김종효 대표 | ![]() |
[Time] 11:00~11:20 |
의료 인공지능 기업 뷰노가 만든는 개인용 만성질환 토탈 솔루션 하티브 | [Speaker] 뷰노 임석훈 사업본부장 | ![]() |
[Time] 11:20~11:40 |
렌즈프리 현미경 응용 공동연구 제안 | [Speaker] ㈜솔 이종묵 대표 | ![]() |
[Time] 11:40~12:00 |
국내 스마트의료기기 글로벌 선점을 위한 기업의 역할 패널 토의 | [Speaker] 최재순 교수, 허영 부이사장 | ![]() |
[Time] 12:00~12:30 |
점심식사 | [Time] 12:30~14:00 | ||
제2부 : 국산 의료기기 지원을 위한 병원 프로그램 소개 | |||
탄소소재기반 신소재의료기기 및 정형재활의료기기 지원 | [Speaker] 전북대학교병원 의생명연구원장 고명환 | ![]() |
[Time] 14:00~14:20 |
디지털 치료제 및 전자약의 현재와 미래 | [Speaker] 서울삼성병원 손영민 센터장 | ![]() |
[Time] 14:20~14:40 |
광기반 의료기기의 사용적합성 및 인허가지원 | [Speaker] 단국대학교 모지훈 센터장 | ![]() |
[Time] 14:40~15:00 |
“분당서울대병원 국산의료기기 개발 및 실증 지원 프로그램 사례” | [Speaker] 분당서울대병원 우세준 교수 | ![]() |
[Time] 15:00~15:20 |
국내 스마트의료기기 글로벌 선점을 위한 병원의 역할 패널 토의 | [Speaker] 김철호 교수 | [Time] 15:00~15:20 | |
폐회사 | [Speaker] 허 영 부이사장 | [Time] 15:50~16:00 |
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18한국의료기기안전정보원 주요업무 통합설명회
- [Date] 3.23(Thur) (13:30~16:20)
- [Organizer] 한국의료기기안전정보원
- [Venue] 328호
- [Contact] +82-2-860-4315
의료기기 표준코드 및 공급내역보고 안내 [Speaker] 유통정보관리팀 김지연 선임연구원 [Time] 13:30~14:20 의료기기 신고·인증 주요 업무 및 절차 [Speaker] 인증심사2팀 윤보은 선임연구원 [Time] 14:30~15:20 의료기기 임상시험 통계적 기법-임상통계 보완사례 [Speaker] 혁신성장지원팀 정수연 전문연구원 [Time] 15:30~16:20 -
19K-뇌광학 단위의 발견을 통한 글로벌 안과와 치매시장의 창출과 코로나 변이 바이러스의 광융합파 치료기의 개발
- [Date] 3.23(Thur) (14:00~15:00)
- [Organizer] ㈜스마트 한방광학
- [Venue] 310호
- [Contact] +82-2-358-9378
K-뇌광학 단위의 발견을 통한 글로벌 비수술 안과/치매 시장의 창출 [Speaker] ㈜스마트한방광학 이상엽 대표 [Time] 14:00~14:40 코로나 변이 바이러스의 광융합파 치료기의 개발 [Speaker] ㈜스마트한방광학 이상엽 대표 [Time] 14:40~15:00 -
20The role of hospitals and companies to preoccupy the global market for domestic medical devices
- [Date] 3.23(Thur) (14:00~15:00)
- [Organizer] 스마트의료기기 상생포럼,Medical Device Industry Promotion Foundation
- [Venue] Rm. 308
- [Contact] 02-6347-5101
개회사 [Time] 10:00~10:10 CES 2023을 빛낸 국내 스마트의료기기 기업 소개 [Time] 10:10~12:00 국산 의료기기 지원을 위한 병원 프로그램 소개 [Time] 14:00~15:50 폐회사 [Time] 15:50~16:00