Jimin Choi, Managing Director of BCGMED, will speak at a global medical device inspections workshop hosted by the Regulatory Affairs Professionals Society (RAPS) on October 27, 2026.
About RAPS: A Global Organization for Regulatory Professionals
Founded in the United States in 1976, the Regulatory Affairs Professionals Society (RAPS) is a nonprofit professional organization supporting regulatory and quality professionals across the medical device, in vitro diagnostic, pharmaceutical, biopharmaceutical, and digital health sectors. According to RAPS, the organization has more than 30,000 members across 114 countries and is the world's largest global professional organization dedicated to regulatory and quality affairs for healthcare products. RAPS promotes professional development and international regulatory knowledge exchange through education and training, professional certifications, research and publications, international conferences, and professional networking. These activities facilitate the exchange of regulatory knowledge and practical experience across jurisdictions while supporting the advancement of healthcare product safety and effective regulatory practices.
The upcoming workshop, "Navigating Global Medical Device Inspections: Expectations from US, EU, China, Korea, and Japan," will examine medical device inspection frameworks and regulatory requirements in the United States, European Union, China, South Korea, and Japan. The program will also address effective inspection preparation and regulatory compliance strategies for medical device manufacturers operating across international markets. The four-hour virtual workshop will bring together regulatory affairs and quality management professionals from different jurisdictions. Participants will explore inspection priorities and quality management system expectations under the US FDA, European regulatory frameworks and MDSAP, China's NMPA, Korea's MFDS, and Japan's PMDA. Drawing on practical inspection experiences and case studies, the program will also address responses to inspection findings, corrective actions, and strategies for improving inspection readiness.
Sharing Practical Expertise in Korea's MFDS and KGMP Inspections
Jimin Choi, Principal of BCGMED, will present Korea's regulatory perspective in a session titled:
Korea MFDS GMP/inspections: key regulations, inspection focus areas, evidence expectations, effective remediation
The presentation will examine the principal regulatory requirements of Korea's medical device GMP framework, key areas of focus during KGMP inspections, expectations for objective evidence, and effective approaches to addressing inspection findings. Particular attention will be given to practical challenges faced by overseas manufacturers preparing for KGMP inspections, including quality management system compliance, consistency of documents and records, sufficiency of inspection evidence, root cause analysis of nonconformities, and corrective and preventive actions (CAPA). The session will provide an overview of Korean regulatory inspection expectations and their implications for manufacturers seeking to demonstrate compliance. Jimin Choi has an extensive experience in quality management systems, GMP compliance, manufacturing quality oversight, and regulatory inspections across the medical device and biopharmaceutical industries. Drawing on his experience supporting a number of KGMP audits and assessments, he will share practical perspectives to help international medical device manufacturers understand Korea's regulatory requirements and prepare effectively for KGMP inspections.
Exchanging Knowledge with Global Medical Device Regulatory Experts
Connecting Korean Regulatory Expertise with Global Markets
For medical device manufacturers operating across multiple jurisdictions, effective inspection readiness requires more than compliance with individual national regulations. It also requires an understanding of each regulatory authority's inspection approach, expectations for objective evidence, and how these requirements can be consistently incorporated into quality management systems. Overseas manufacturers seeking to enter the Korean market must consider MFDS product authorization requirements alongside KGMP compliance obligations. Early assessment of product-specific regulatory requirements and manufacturing-site quality system readiness is therefore an important part of developing a structured regulatory strategy. Through its participation in this RAPS workshop, BCGMED aims to share practical experience in Korean medical device regulations and KGMP inspections, contributing to a broader understanding of Korea's regulatory environment and the similarities and differences among international inspection frameworks.
BCGMED is a regulatory consulting firm supporting international medical device and in vitro diagnostic manufacturers entering the Korean market. Its services encompass MFDS regulatory approvals, KGMP inspection support, market access strategy, and post-approval regulatory compliance management. Guided by its commitment, "One Stop, We Don’t Stop.", BCGMED provides integrated regulatory support based on a comprehensive assessment of product characteristics and applicable requirements, from initial market entry through post-approval management.
Official Website: https://bcgmed.com
Event Information
Event: Navigating Global Medical Device Inspections: Expectations from US, EU, China, Korea, and Japan
Organizer: Regulatory Affairs Professionals Society (RAPS)
Format / Venue: Virtual Workshop
Full Event Schedule — New York, USA: October 27, 2026, 10:00 AM–2:00 PM (EDT, UTC−04:00)
Speakers (including panel participants):
Grace F. Palma (China Med Device, part of Accel Groups)
Christine Forcier (Intertek)
Viki Chen (China Med Device, part of Accel Groups)
Jimin Choi (BCGMED, part of Accel Groups)
Ira Dave (Elixir Medical Corporation)
Rica Morris (ELIQUENT Life Sciences)
Noemi Portillo Schambach (Shockwave Medical)
Kim Trautman (USC Kim Center Advisory Committee)
Omar Gonzalez (Eliquent; panel participant listed in the agenda)
Official Event Information:
Event Registration:
https://www.raps.org/ems-event-booking-page.html?id=22D4648B-8E9C-4817-B5FF6112DB1CF7D2