Jimin Choi, Managing Director and Principal of BCGMED, was featured in The Elendi Files, a regulatory affairs interview series produced by ElendiLabs, a global platform for pharmaceutical and medical device regulatory consulting. Published on October 17, 2026, the interview explored key regulatory requirements and practical considerations for international medical device manufacturers seeking market access in South Korea.
Hosted by Teddy, General Manager of ElendiLabs, the discussion examined South Korea's Ministry of Food and Drug Safety (MFDS) regulatory framework, including medical device registration pathways, Korea Good Manufacturing Practice (KGMP) inspections, the use of Medical Device Single Audit Program (MDSAP) evidence, local importer Quality Manager requirements, license transfers, technical documentation, labeling compliance, and the acceptance of testing evidence. ElendiLabs
Understanding Korea's Medical Device Registration and Equivalence Framework
One of the central topics of the interview was the distinction between South Korea's medical device registration framework and the US FDA 510(k) pathway. Jimin Choi explained the respective roles of MFDS-designated Third Party Authorities (TPAs) and the National Institute of Medical Device Safety Information (NIDS) in the technical documentation review and certification processes for Class II medical devices. The discussion also addressed the importance of evaluating substantial equivalence against medical devices already registered in South Korea, particularly in relation to intended use, principles of operation, materials, and performance characteristics. Even when a medical device has received regulatory clearance in another jurisdiction, manufacturers must separately evaluate whether its existing technical documentation meets Korean regulatory requirements. Understanding these differences enables international manufacturers to assess the applicability of existing regulatory evidence and identify potential documentation gaps before initiating the Korean registration process.
KGMP Inspections and Strategic Use of MDSAP Evidence
Korea's medical device GMP framework was another major focus of the interview. Jimin Choi outlined the distinctions among initial, additional, change, and periodic KGMP inspections, highlighting how inspection requirements and the supporting quality management system documentation may vary depending on the applicable audit category. Particular attention was given to the use of MDSAP audit reports in supporting KGMP conformity assessments. The discussion emphasized that eligibility to use MDSAP evidence depends on specific regulatory conditions, including the applicable inspection type, product group coverage, audit report suitability, and the status of corrective actions associated with identified nonconformities. Holding an international quality management system certification does not, by itself, automatically exempt a manufacturer from Korea's KGMP inspection requirements. For international manufacturers, understanding these distinctions is essential when evaluating inspection readiness and developing an appropriate regulatory compliance strategy.
Local Importer Responsibilities and License Lifecycle Management
Entering the Korean medical device market requires manufacturers to consider not only product-specific regulatory requirements but also the legal responsibilities of locally licensed importers. The interview addressed the qualification and training requirements for Quality Managers employed by Korean medical device importers, as well as regulatory procedures associated with changing local license holders. Jimin Choi also discussed the distinctions between transferring existing product licenses and pursuing independent registrations for identical products under applicable Korean regulatory pathways. These considerations become particularly relevant when overseas manufacturers change local distribution arrangements or seek to establish alternative market access structures. The discussion highlighted the importance of establishing clear responsibilities for regulatory compliance, product licensing, and quality management from the outset, while anticipating potential changes in distribution and commercial operations.
Technical Documentation, Korean Labeling, and Testing Evidence
The final part of the interview focused on technical documentation and the regulatory acceptability of supporting test reports. Topics included Korean-language Instructions for Use (IFUs), product labeling requirements, consistency between approved product information and supporting documentation, and evidence requirements for electrical safety, electromagnetic compatibility, and biological safety testing. Jimin Choi discussed the importance of reviewing existing technical files and test reports against Korean regulatory expectations before submission. This process helps manufacturers identify documentation gaps, determine whether additional testing or supporting evidence may be required, and establish a more informed registration strategy. The discussion also addressed how device classification, the availability of an appropriate Korean predicate, KGMP inspection requirements, and the acceptability of testing evidence can influence overall registration timelines and costs.
Connecting Global Medical Technology with Korean Regulatory Expertise
Successful medical device market entry in South Korea requires more than understanding individual regulatory procedures. Manufacturers must coordinate product registration, quality management system compliance, technical documentation, testing evidence, and local importer responsibilities within a consistent regulatory strategy. Through this interview, BCGMED contributed practical perspectives on Korea's medical device regulatory environment to an international audience of medical technology manufacturers and regulatory professionals. BCGMED is a South Korea-based regulatory consulting firm supporting international manufacturers of medical devices and in vitro diagnostic medical devices. Its services encompass MFDS product registration, KGMP compliance and inspection support, regulatory assessment, and post-approval regulatory maintenance. Guided by its commitment, “One Stop, We Don’t Stop.”, BCGMED helps clients navigate Korean regulatory requirements and manage their market access activities.
Official Website: https://bcgmed.com
Further Information
Program: The Elendi Files
Interview Title: Navigating South Korea MFDS Medical Device Market Access: Strategic Insights on KGMP Audits, MDSAP Reliance, Class II Equivalence, Quality Manager Rules, and License Transfers
Publication Date: October 17, 2026
Publisher and Program Host Organization: ElendiLabs
Interviewer: Teddy (ElendiLabs)
Featured Guest: Jimin Choi (BCGMED)
Format: Global medical product regulatory affairs interview and published transcript
Topics Covered: MFDS medical device registration, KGMP inspections, MDSAP, Class II equivalence assessments, local Quality Manager requirements, license transfers, labeling compliance, and testing evidence requirements
Official Interview Transcript:
https://elendilabs.com/en/articles/kor-MFDS-KGMP-MDSAP-medical-device-market-access-1xUWRwwiSz5IoQvhVmvLmE
The Elendi Files Official Program Page:
https://elendilabs.com/en/podcast