-----------------------------------------------------------------------------
HOME > Seminar > Seminar Schedule

KIMES Seminar

3/23(Thur)
  • 1
    CE 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
  • CE MDR Regulation [Speaker] BSI Group | Michael Weissig | Managing Director [Time] 14:00~18:00
  • 2
    Person 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
  • 3
    Vietnam · 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
  • 4
    Current 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
  • 5
    Understanding 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
  • 6
    Medical 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
  • 7
    European 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
  • 8
    Digitalization of Korean medical industry
    • [Date] 3.23(Thur) (10:05~11:25)
    • [Organizer] KMDIA
    • [Venue] Rm. 307
    • [Contact] +82-2-596-0460
  • 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
  • 9
    의료기기 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
  • 10
    2023 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
  • 11
    EU Regulatory MDD -> MDR
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
  • 12
    US 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
  • 13
    Australian 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
  • 14
    Entire 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
  • 15
    YONSEI 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
 [Time] 16:30~17:00
  • 17
    국산 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
  • 18
    한국의료기기안전정보원 주요업무 통합설명회
    • [Date] 3.23(Thur) (13:30~16:20)
    • [Organizer] 한국의료기기안전정보원
    • [Venue] 328호
    • [Contact] +82-2-860-4315
    등록하기
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
  • 19
    K-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
  • 20
    The 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