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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. 

On March 27, 2025, South Korea’s Ministry of Employment and Labor (MOEL) released a list of 72 new chemical substances that were manufactured or imported into the country during the first quarter (Q1) of 2025. The announcement is part of Korea’s continued effort to ensure chemical safety in workplaces under the Korea Occupational Safety and Health Act (KOSHA). Consequently, employers are urged to review the published list, implement the recommended safety measures, and educate all workers, especially foreign employees, on the proper chemical handling practices. 

Key Contents 

• Total Substances Announced: 72 new chemical substances registered in Q1 2025. 

• Hazardous Substances Identified: 32 substances, including 2-methylpiperazine, found to pose risks such as: 

• Acute toxicity 

• Reproductive toxicity 

• Skin corrosion/irritation 

 Compliance Requirements for Manufacturers and Importers 

• Pre-Notification Obligation: Manufacturers and importers must submit a hazard and risk assessment report to the MOEL 30 days before production/import. 

• Safety Measures for Employers: 

• Provide personal protective equipment (PPE) 

• Install local exhaust ventilation 

• Maintain and display Material Safety Data Sheets (MSDS) 

• Use proper hazard warning labels 

Foreign Worker Safety 

• To improve chemical safety for foreign employees, MOEL has published MSDS and label training materials in 17 languages, including English, Vietnamese, Chinese, and more. These materials help workers recognize hazard symbols and understand key safety instructions.