South Korea Regulatory News

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 ...

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 (Q...

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. 

On 28 March 2025, the South Korean Ministry of Environment published a draft amendment to the Enforcement Rules of Consumer Chemical Products and Biocides Safety Control Act. The proposed changes aim ...

On 28 March 2025, the South Korean Ministry of Environment published a draft amendment to the Enforcement Rules of Consumer Chemical Products and Biocides Safety Control Act. The proposed changes aim to align with recent amendments to the Act on Registration and Evaluation of Chemicals (K-REACH) and to improve regulatory efficiency and transparency. 

Key Objectives of the Amendment 

• Legal Alignment: Reflect changes from the revised K-REACH, which take effect on August 7, 2025, particularly the removal of the definition of “hazardous chemicals.” Related legal references are updated accordingly. 

• Simplified Document Submission: Companies modifying previously approved biocidal products or household chemical products will no longer be required to resubmit documents already held by the authorities from previous applications. However, this exemption does not apply to changes involving the transfer of rights or obligations. 

• Enhanced Public Disclosure: To ensure clarity and transparency, information on the location of manufacturing facilities will now be included in the publicly disclosed information about approved biocidal substances and products. 

Public Comment Period 

The MoE is accepting feedback from individuals and organizations until May 7, 2025. Comments should include the submitter’s position (support or opposition) and reasoning, along with their contact details. 

On March 28, 2025, the National Institute of Chemical Safety in South Korea announced a partial revision of the Standards for Installation and Management of Hazardous Chemical Transport Facilities. Th...

On March 28, 2025, the National Institute of Chemical Safety in South Korea announced a partial revision of the Standards for Installation and Management of Hazardous Chemical Transport Facilities. This revision aims to clarify and specify the standards for vehicle transport facilities to reduce confusion in the file and enhance the chemical safety of transport facilities.  

Specifically, the current regulations for vehicle-mounted tanks require a minimum steel plate thickness of 3.2 mm or equivalent materials for all substances, but this approach is impractical for corrosive substances, leading to increased vehicle weight and reduced steel lifespan. To address this, the regulations have been revised to allow materials tailored to the specific needs of corrosive substances. However, existing guidelines for lining materials and methods are unclear, resulting in frequent accidents despite the use of linings. 

Key Content 

• Target audience: Operators of hazardous chemical vehicle transport facilities, specifically those transporting corrosive substances. 

• Stakeholders: The public, especially those impacted by the transportation of hazardous chemicals. 

• Key change: The revised standards specify that when transporting corrosive substances, the selection of appropriate corrosion-resistant lining materials must be clearly defined. This includes providing practical guidance on how to inspect and apply the correct lining materials. 

Submission of Comments  

Individuals, organizations, and associations wishing to provide feedback on the proposed revisions to the "Standards for Installation and Management of Hazardous Chemical Transport Facilities" must submit their comments by April 18, 2025. Feedback can be submitted online through the National Legislative Center website, or by email with the necessary contact details. 

On April 8, 2025, South Korea issued a notice of administrative announcement on a partial revision on the result of chemical hazard evaluation. This revision is based on the completion of toxicity eva...

On April 8, 2025, South Korea issued a notice of administrative announcement on a partial revision on the result of chemical hazard evaluation. This revision is based on the completion of toxicity evaluations for existing chemicals under the K-REACH Act. The revised notice includes details on the chemical substance names, hazard information, whether substances are hazardous, and other relevant results. Additionally, the notice includes the publication of the names of newly evaluated chemical substances after the expiration of their data protection periods. 

Key Changes 

1. Expiration of Data Protection: 

• Following the expiration of the data protection (2023), chemical substance names that were previously protected will now be made public. This includes four substances, with corrections to one item. 

2. Hazard Evaluation of Existing Substances: 

• The hazard evaluation results for 29 substances, conducted between February and June 2024, will be included in Annex 2.  

3. Additional Data for Previously Announced Chemicals: 

• Four additional substances will have their data updated, and 20 substances will be assigned unique identifiers based on toxicity status. 

4. Chemical Substance Details: 

• The notice will include comprehensive details such as CAS numbers, hazard status, and key hazard characteristics for substances that have been evaluated. 

Submission of Comments 

Interested individuals, institutions, and associations are invited to submit their feedback on the proposed changes by April 28, 2025. Comments should be addressed to NICS and should include details such as the subject of the feedback, contact information, and the reasons for any suggested revisions. 

On February 5, 2025, a group of 13 congressmen in South Korea proposed amendments to the Act on Registration and Evaluation of Chemical Substances (also known as K-REACH). The purpose of this new prop...

On February 5, 2025, a group of 13 congressmen in South Korea proposed amendments to the Act on Registration and Evaluation of Chemical Substances (also known as K-REACH). The purpose of this new proposal is, first, to improve the transparency of the chemical registration process, especially in the process of joint submission and its cost sharing. Secondly, it aims to enhance the efficiency of the Only Representative (OR) appointment system by addressing gaps related to the transfer of responsibilities when the OR is changed.  

Key Amendments and Changes 

1. Fair and Transparent Cost Allocation for Joint Registration: 

• The amendments propose a clear and fair framework for cost sharing for joint registrations of chemicals. 

• Costs will be allocated based on objective criteria, taking into account the interests of each party and the specific manufacturing or import volumes. 

• The proposal ensures transparency by requiring clear and verifiable evidence for all cost allocations. 

2. Dispute Resolution for Registration Conflicts: 

• If disputes arise during the joint registration process the parties will be able to seek mediation from the Ministry of Environment. 

• This will ensure that disputes over shared registration materials or costs are resolved in a fair and transparent manner. 

3. Protection for Latecomer Registrants: 

• To protect the interests of latecomer registrants, the amendments propose a formal process to resolve issues that cannot be settled through negotiation. 

• This protection will ensure that latecomer registrants who joined the joint submission at a late stage are not unfairly burdened with excessive fees or delays in the registration process. 

4. Clarification of the OR System for Foreign Manufacturers: 

• The amendments will address gaps in the law by providing clarity regarding the transfer of responsibilities when a foreign manufacturer changes their Only Representative. 

• The responsibilities of the previous OR, including completed registrations, will be transferred to the new OR to ensure continuity in the registration process. 

• Foreign manufacturers must report the change to the Ministry within one month. 

Public Feedback and Status of the Proposal  

• Public feedback was accepted from  February 7 to February 21, 2025.  

• The proposal is still under committee review. When there are further updates regarding this amendment, GPC will continue to update the news.  

On March 18, 2025, the South Korean Ministry of Food and Drug Safety (MFDS) notified the World Trade Organization (WTO) of a proposed amendment to the Enforcement Rule of the Special Act on Imported F...

On March 18, 2025, the South Korean Ministry of Food and Drug Safety (MFDS) notified the World Trade Organization (WTO) of a proposed amendment to the Enforcement Rule of the Special Act on Imported Food Safety Control.  

The purpose of the amendment is to enhance efficiency by expanding the circumstances under which importers can request a change in the purpose of raw materials. It also aims to establish a legal framework for the issuance of electronic export health certificates for food products.  

Key Updates 

• Raw material sourcing during crisis: Allows businesses to purchase raw materials from other manufacturers if domestic supply is disrupted due to global crises such as wars, pandemics, or natural disasters. 

• Exemption of registration change fee: Exempts businesses from registration change fees if the change is due to administrative district reorganization, and the applicant is not responsible for the change. 

• Business Registration: New requirements for businesses to include mobile numbers and email addresses on registration forms. 

• Import Declaration: Clear guidelines for submitting photos with import declarations, including specific labeling and packaging details. 

• Export Hygiene Certificates: Introduction of electronic formats for export food hygiene certificates and updated document templates. 

Public Feedback 

MFDS invites public feedback on the proposed changes until April 21, 2025. For more information and to submit comments, visit the Food and Drug Safety Administration (FDA) website.