한국, 국제의료기기규제당국자포럼(IMDRF) 의장국으로 선임
한국, 국제의료기기규제당국자포럼(IMDRF) 의장국으로 선임
의료기기 분야에서 국가적 위상 높아져 국제 의료기기 제도 선도 기대
식품의약품안전처(처장 이의경)는 러시아 모스크바에서 개최된 제15차 국제의료기기규제당국자포럼(IMDRF) 정기총회(3.18.~21.)에서 우리나라가 ’21년 의장국으로 선임되었다고 밝혔습니다.
우리나라는 ’17년 IMDRF에 가입하였으며 매년 IMDRF 총회에 참석하여 우리나라 의료기기 제도를 소개하는 등 적극적으로 의료기기 규제의 국제 조화를 위해 노력하였습니다.
국제의료기기규제당국자포럼(IMDRF, International Medical Device Regulators Forum) : 의료기기 규제조화를 위해 구성된 선진 10개국 규제 당국자간 협의체로 11년도에 설립
회원국(10개국) : 한국, 호주, 브라질, 캐나다, 중국, 유럽연합, 일본, 러시아, 싱가포르, 미국
우리나라는 이번 의장국 선임으로 국제 의료기기 규제 정책 수립 및 IMDRF에서 제·개정하는 가이드라인 마련에도 주도적 역할을 하게됩니다.
아울러, ’21년에는 의장국인 우리나라에서 정기총회가 개최되어, 해외 규제당국과 국내 의료기기 업계와의 소통의 장이 마련됨으로써 해외 진출을 희망하는 국내업체에는 많은 도움이 될 것입니다.
식약처는 IMDRF의 의장국이 되어 우리나라 의료기기 산업의 국제 신인도를 높이는 계기가 될 것이며, 앞으로도 우리나라 의료기기 제도의 국제 조화와 국내 의료기기의 세계 진출을 위하여 지속적으로 노력할 계획이라고 밝혔습니다.
IMDRF(International Medical Device Regulators Forum)
of the IMDRF-15 MANAGEMENT COMMITTEE
18 to 21 March 2019
The fifteenth meeting of the Management Committee (MC) of the International Medical Device
Regulators Forum (IMDRF) took place in Moscow, Russia, from 18 to 21 March 2019. The
meeting was chaired by Russia. The MC consists of regulators from Australia, Brazil, Canada,
China, the European Union (EU), Japan, Russia, Singapore, South Korea and the United States of
America (USA). Representatives of the World Health Organization (WHO) participated as Official
Observers and the Asian Harmonization Working Party (AHWP), Pan American Health
Organization (PAHO) and Asia-Pacific Economic Cooperation Life Sciences Innovation Forum
Regulatory Harmonization Steering Committee (APEC LSIF RHSC) participated as Regional
On Monday, March 18th, IMDRF/DITTA Joint Workshop on “Optimization of Standards for
Regulatory Use” in the frame of IMDRF with about 200 participants has been successfully held.
Industry representatives and the regulators presented their view on the Standards
development, improvements, and guidance. A panel discussion finalized the Workshop.
On the first day March 19th, an Open Stakeholder Forum was held. The Forum included
approximately 300 participants representing regulators, industry, and the research community.
In the morning, participants had an opportunity to hear regulatory updates from Australia,
Brazil, Canada, China, EU, Japan, Russia, Singapore, South Korea and the USA and update reports
on IMDRF’s eight current working groups. A Question & Answers Session was held after each
The IMDRF’s eight current working groups are:
a. Regulated Product Submission (RPS) - Canada
b. Medical Device Adverse Event Terminology - Japan
c. Good Regulatory Review Practices - USA
d. Standards - USA
e. Personalized Medical Devices-Australia
f. Unique Device Identification - EU
g. Medical device clinical evaluation - China
h. Medical device Cybersecurity – Canada/USA
In the afternoon, there was a Stakeholder session including Official Observers, RHIs and
Invited Observers. Brief updates were provided by:
1. Official Observers
a. APEC LSIF RHSC represented by Taiwan Food and Drug Administration
b. AHWP represented by Saudi Food and Drug Authority
3. Invited Observers
a. Eurasian Economic Commission
d. International association of developers, producers and users of medical
At the end of the Day 1, a special session on the regulatory approach for NGS testing has been
performed, which was followed by a panel discussion on regulatory approaches for this new
technology. The panel discussion explored the challenges, opportunities and the complexity of
medical device validation and verification in the context of the current trends in New Generation
On the second day, the MC firstly held an open session to hear regulatory updates on the
progress achieved by Invited Observers:
a. Saudi Arabia
c. Republic of Kazakhstan
d. Kyrgyz Republic
After that, the MC heard a presentation from Argentina ANMAT.
The MC received feedback with respect to the progression of each IMDRF work item from DITTA
a. DITTA presented results of discussion of IMDRF/DITTA Joint Workshop and suggested
discussion on forthcoming IMDRF-16 Workshop in September
b. GMTA presented a Pilot training proposal for IMDRF guidance documents.
In the afternoon MC open session, Medical Device Nomenclatures issues were presented and
discussed by the Global Medical Device Nomenclature (GMDN) Agency, WHO and the EU.
The afternoon Closed session of the Day 2 MC members and Official Observers started with
discussions of matters arising around the documents put forward from the current working
Following this discussion, the MC discussed the matters arising from the Open Stakeholder
Forum and the session with invited observers and industry.
On the third day, the MC discussed and made decisions regarding the documents put forward
from current working groups, the New Work Item Proposals and New Work Item Extensions
proposed by MC members, as well as some procedural issues (See Annex).
DECISIONS BY THE IMDRF MANAGEMENT COMMITTEE
• The MC approved the proposed documents, “Clinical Evaluation – Key Definitions
and Concepts”, “Clinical Investigation” and “Clinical Evaluation”, of the Medical
Device Clinical Evaluation Working Group, for a two-month public consultation
• The MC approved the proposed document, with necessary revisions “Personalized
Medical Devices – Regulatory Pathways of the Personalized Medical Devices Working
Group, for a two-month public consultation period.
• The MC approved the revised Final N9 document, “Non-In Vitro Diagnostic Medical
Device Market Authorization Table of Contents (nIVD MA ToC)” of the Regulated
Product Submission (RPS) Working Group.
• The MC approved the revised Final N13 document, “In Vitro Diagnostic Medical
Device Market Authorization Table of Contents (IVD MA ToC)” of the Regulated
Product Submission (RPS) Working Group.
• The MC approved the Final N43 document “Terminologies for Categorized Adverse
Event Reporting (AER): terms, terminology structure and codes (Annex E-F)” of the
Medical Device Adverse Event Terminology Working Group.
• The MC approved the Final N52 document “Principles of Labeling for Medical
Devices and IVD Medical Devices” of the Good Regulatory Review Practices Working
• The MC approved the Final N48 document “Unique Device Identification System (UDI
system) Application Guide”, with the necessary revisions of the Unique Device
Identification System (UDI) Working Group and decided to close the Unique Device
Identification System (UDI) Working Group at this time.
• The MC agreed to post the Final N53 document “Use of UDI Data Elements Across
IMDRF Jurisdictions” and the Final N54 document “System Requirements related to
the use of UDI in healthcare including selected use cases” of the Unique Device
Identification System (UDI) Working Group on the IMDRF website as information
• The MC approved the NWIP: Review and Update of the GHTF Principles of In-Vitro
Diagnostic (IVD) Medical Devices Classification (GHTF/SG1/N45:2008).
• The MC approved the NWIP: IMDRF Standard Developing Organizations (SDO)
• The MC discussed the proposed changes to SOP which includes the New Work Item
Proposal (NWIP) adoption process, updating the IMDRF Membership Criteria to
provide additional clarity to become an Official Observer and a Management
Committee Member of IMDRF and finalizing a Record of Discussion process and
format. These were approved and the SOP will be revised accordingly.
• The MC continued their discussions on a document which indicates the
implementation of IMDRF documents by member jurisdictions, and will be further
discussed in IMDRF-16
• South Korea has volunteered to serve as the 2021 Chair of the IMDRF
March 21, 2019