South Korea Notifies WTO of Proposed Amendments to Medical Device Regulation

On May 9, 2025, South Korea notified the World Trade Organization (WTO) of proposed amendments to the "Regulation on the Permission, Notification, Review, etc of Medical Devices”. The revision aims to clarify cybersecurity documentation requirements for medical devices that use wired or wireless communication. It also aligns clinical trial data requirements with international standards and addresses administrative inefficiencies identified during prior regulatory operations. 

Key Contents  

1. Procedures for Deferral of New Health Technology Assessment 

The regulations now establish clear steps for applying for approval or certification to defer new health technology evaluations. This includes adding clinical evaluation data as a new type of clinical trial documentation and providing detailed guidance on how to prepare each section. 

2. Unified Oversight for Class II Medical Device Certification 

Applicants seeking confirmation for products equivalent to already-certified Class II devices must now submit documentation to the Ministry of Food and Drug Safety (MFDS) which centralizes the process. 

3. Clarification of Manufacturing and Import Filing Procedures 

Following the amendment to the Medical Device Act Enforcement Rules, the procedure for reviewing manufacturing and import reports has been clearly defined to enhance transparency. 

4. Cybersecurity Requirements for Medical Devices 

The amendment introduces a formal definition of cybersecurity for medical devices and requires that detailed cybersecurity information be included in approval applications. Multiple related provisions and documentation templates have been updated accordingly. 

5. Support Measures for Innovative Medical Devices 

Newly developed medical devices are now eligible for expedited review. However, the exemption from submitting clinical trial data based on equivalence during post-market surveillance is restricted to ensure safety. 

6. Expanded Scope for Technical Documentation 

Examples of situations requiring the submission of clinical data are now included to help clarify when such data is necessary, thereby improving predictability and compliance. 

Public comments 

Individuals or organizations with feedback on the draft amendment may submit written comments by May 20, 2025.