BCGMED’s Jimin Choi will present on Korea’s medical device KGMP inspection pathways at the 94th China International Medical Equipment Fair (CMEF) in Beijing on October 22, 2026.
The presentation forms part of “知汇公开课,” a separate public lecture series organized by Wiselink at its A1 K36 booth during the exhibition. CMEF is organized by Reed Sinopharm Exhibitions Co., Ltd.; BCGMED will participate as a speaker in Wiselink’s lecture program.
Preparing for On-Site Inspections and Document Reviews
The presentation, “Navigating Korea's KGMP Inspection Pathway: On-Site or Document Review?”, is scheduled for October 22, 10:00–11:00 AM Beijing time, equivalent to 11:00 AM–12:00 PM in Korea.
The session will examine considerations for determining the applicable KGMP inspection pathway and the circumstances addressed by on-site inspections and document reviews. It will compare the two approaches in terms of documentation, timelines, and potential risks, highlighting practical issues for manufacturers preparing for assessment.
The discussion will also address document review preparation, including the structure of the documentation system and priorities for reviewing materials before submission. Further topics include considerations for different product types and common preparation problems identified in the lecture outline.
For manufacturers entering Korea and the regulatory and quality teams supporting them, a key planning task is to understand how the applicable inspection pathway affects the evidence and preparation required. The session is intended to provide a practical reference for identifying the questions to resolve and organizing documentation priorities.
CMEF and the International Market Access Lecture Program
Launched in 1979 and held each spring and fall, CMEF combines medical device exhibitions with business exchange, forums, and education. Its scope spans medical imaging, in vitro diagnostics, medical electronics, operating room equipment, and medical robotics, bringing together products, technologies, and services across the medical device industry. Official CMEF overview
The 94th edition will take place October 21–24, 2026, at the Capital International Exhibition & Convention Center in Beijing. During the exhibition, Wiselink will hold six public lectures over October 21–23. The program covers regulatory and market access topics concerning the United States, Southeast Asia, Korea, Japan, the European Union, and Latin America. The Korea KGMP presentation is the morning session on the program’s second day.
Visitors planning to attend in person can use the official CMEF visitor registration page for exhibition admission. For participation in Wiselink’s lectures and viewing instructions, refer to its lecture announcements. Wiselink has announced that all six lectures will be livestreamed through the WeChat Channels account “出海合规找知汇.” Exhibition registration and participation instructions for Wiselink’s lectures should be checked separately.
BCGMED is a regulatory consulting company supporting Korean market entry for medical devices and in vitro diagnostic devices. It assists international manufacturers and Korean importers with Ministry of Food and Drug Safety (MFDS) regulatory submissions, technical documentation preparation and review, KGMP assessment preparation, and post-approval maintenance. One Stop, We Don’t Stop. Further information is available on the official BCGMED website.
Event Information
Event: 94th China International Medical Equipment Fair (CMEF) / 第94届中国国际医疗器械博览会
Exhibition Organizer: Reed Sinopharm Exhibitions Co., Ltd. / 国药励展展览有限责任公司
Public Lecture Organizer: Wiselink
BCGMED Participation: Speaker in Wiselink’s “知汇公开课” public lecture series
Format / Venue: Capital International Exhibition & Convention Center (Beijing) / 首都国际会展中心（北京）, China; Wiselink booth A1 K36
Full Exhibition Schedule — Korea: October 21–23, 2026, 10:00 AM–6:00 PM daily; October 24, 10:00 AM–5:00 PM / KST, UTC+09:00, Asia/Seoul
Full Exhibition Schedule — United States, New York: October 20, 2026, 9:00 PM–October 21, 5:00 AM; October 21, 9:00 PM–October 22, 5:00 AM; October 22, 9:00 PM–October 23, 5:00 AM; October 23, 9:00 PM–October 24, 4:00 AM / EDT, UTC−04:00, America/New_York; reference times for US readers
Full Exhibition Schedule — Beijing, China: October 21–23, 2026, 9:00 AM–5:00 PM daily; October 24, 9:00 AM–4:00 PM / China Standard Time, UTC+08:00, Asia/Shanghai
Wiselink Lecture Schedule — Beijing, China: October 21–23, 2026, 10:00–11:00 AM and 2:00–3:00 PM daily / UTC+08:00
Wiselink Lecture Schedule — Korea: October 21–23, 2026, 11:00 AM–12:00 PM and 3:00–4:00 PM daily / KST, UTC+09:00
Wiselink Lecture Schedule — New York, United States: October 20–22, 2026, 10:00–11:00 PM daily, and October 21–23, 2:00–3:00 AM daily / EDT, UTC−04:00
Speakers — Complete Wiselink Public Lecture Series, in Published Order:
Eddie (Wiselink知汇)
Aisy (Wiselink知汇)
Jimin Choi (Wiselink知汇)
神崎博维 (Wiselink Group)
Dr.Nelson Xie (Wiselink Group)
Danny (Wiselink知汇)
BCGMED Presentation: Navigating Korea's KGMP Inspection Pathway: On-Site or Document Review?
BCGMED Presentation Time — Korea: October 22, 2026, 11:00 AM–12:00 PM / KST, UTC+09:00
BCGMED Presentation Time — New York, United States: October 21, 2026, 10:00–11:00 PM / EDT, UTC−04:00
BCGMED Presentation Time — Beijing, China: October 22, 2026, 10:00–11:00 AM / China Standard Time, UTC+08:00
Livestream: WeChat Channels account “出海合规找知汇”
Official Event Information: CMEF website
Official Exhibition Dates and Opening Hours: CMEF English website
Wiselink Lecture Announcements: Official promotional link 1, Official promotional link 2
Visitor Registration — CMEF Exhibition: Official visitor registration page