The Ministry of Food and Drug Safety (MFDS) is currently advancing a significant regulatory reform scheduled for implementation in December 2026. This regulatory reform is aimed at transitioning the medical device change approval system from a regulator-driven model to one in which manufacturers and importers take primary responsibility for managing changes autonomously.

Under the current system, virtually all changes – except those designated by the MFDS as minor – require prior MFDS change approval or certification. Under the new system, mandatory pre-approval will be limited to changes that significantly affect safety or efficacy, while all other changes will be managed under a negative regulation model in which companies independently assess and control modifications.

This regulatory shift aligns with change management frameworks already in operation at the US FDA, EU MDR, and Japan's PMDA. It is part of a broader push to modernize regulation and better accommodate the pace of medical device innovation — including continuous product improvements, software updates, raw material changes, and supply chain variability. Under the new system, manufacturers will be expected to go beyond simply determining whether a change requires regulatory approval. They will be required to operate a documented, MFDS-approved change management process that systematically covers safety and efficacy impact assessment, risk management, verification and validation (V&V), and record keeping. For importers, the obligations are equally significant: close coordination with overseas manufacturers to secure and review change-related documentation, and the establishment of internal systems capable of evaluating and managing changes in accordance with Korean regulatory requirements.

In this context, MDREX has been selected as a co-research institution to carry out the MFDS- commissioned study, “Application Case Studies for Significant Change Criteria for Medical Devices.

This study will systematically analyze significant change management frameworks applied by the US FDA, EU MDR, and Japan's PMDA, and other major regulatory authorities, and will develop significant change criteria and decision-making standards applicable to medical devices in the Korean regulatory context. The study will also include development of change management SOPs and practical guidelines that manufacturers and importers can directly implement within their quality management systems.

The findings from this study are expected to serve as foundational reference material for MFDS’s forthcoming detailed guidelines and industry operating standards, and are anticipated to have direct implications for how medical device companies in Korea structure their internal change management systems going forward.

We want to hear from you. As we conduct this study, MDREX is actively seeking input from industry practitioners. If your organization has encountered challenges or has specific improvement suggestions related to any of the following, we encourage you to reach out: 

• Determining whether a product change requires regulatory submission
• Managing changes initiated by overseas manufacturers, 
• Software updates and version control
• Raw material changes or component changes
• Manufacturing site changes

Your on-the-ground experience will serve as invaluable reference material in shaping the regulatory framework and developing the guidelines.

MDREX will continue to provide updates on regulatory developments and the progress of this study. We are committed to supporting your organization in effectively adapting to the new change management framework.

For inquiries or to share input, please contact us at pro@mdrex.co.kr.