Korea KC Certification | GCA

  This notification enters into force upon promulgation. On August 20, 2025, South Korea’s Ministry of Food and Drug Safety (MFDS) enacted the Regulation on the Designation of Long-term Follow-up Medical Devices and Submission of Real-world Data . Pursuant to the amended Medical Device Act , the regulation sets forth requirements for designating long-term follow-up medical devices and for medical institutions to submit related real-world data. Key Provisions: Designation of devices: Implantable cardiac pacemakers (with electrodes), breast implants, and hip joints. Regular review: Requires periodic reviews of designations and de-designations, including review frequency. Institution participation: Provides for the registration and approval of medical institutions seeking to participate. Data submission: Outlines the items and methods for submitting real-world data. GCA Korea provides expert support for global companies navigating South Korea’s regulatory requirements....

With the issuance and enforcement of all relevant laws and notifications concerning automotive cybersecurity as outlined below, South Korea officially began implementing the regulations on August 14. Motor Vehicle Management Act(No. 20298) Enforcement Ordinance of Motor Vehicle Management Act(No. 35703) Enforcement Regulations of Motor Vehicle Management Act(No. 1519) Regulations for Performance and Safety Standards of Motor Vehicle and Vehicle Parts(No. 1520) Regulations for Motor Vehicle & Vehicle parts Certification and Investigation(Notice No. 2025-444) Notification on Submission Document Related to Software Updates(Notification No. 2025-445) You can find information on GCA KOREA website, GCA KOREA (gca-global.com) , including KC mark requirement for each product in the Library section and helpful news for easier access to the Korean market. GCA Korea provides expert support for global companies navigating South Korea’s regulatory requirements. Our specialties...

This Decree will take effect on August 14, 2025. On August 12, 2025, the Enforcement Decree of the Motor Vehicle Management Act was amended to set out compliance requirements for motor vehicle manufacturers and others when conducting software updates, and to allow the imposition of administrative fines or penalties on those who fail to meet these requirements. Key provisions include: Impose administrative fines on parties that fail to ensure a vehicle operates normally after a software update. Impose fines on parties that fail to submit, or submit false, update-related materials to the Ministry of Land, Infrastructure and Transport (MOLIT) before carrying out the update. Authorize MOLIT to order restrictions on the operation of vehicles if a cyberattack or threat poses a serious risk to safe operation or public safety. GCA Korea provides expert support for global companies navigating South Korea’s regulatory requirements. Our specialties include  KC EMC ,  KC...

Conformity Assessment Manufacturers, sellers, and importers of broadcasting and communication equipment must verify compliance with technical regulations before distribution, demonstrated through testing and issuing a Certificate or Registration of Conformity.   Follow-Up Management Marketed products are collected for testing, and on-site inspections ensure compliance with obligations like conformity assessment labeling, change reporting, and document retention. Violations lead to sanctions.   Ongoing Compliance with Technical Regulations Products must meet technical regulations (e.g., frequency, output power, bandwidth, electromagnetic emission) even after certification, throughout manufacturing and sales.   Change Reporting & Document Control If a certified product is modified, a revision report must be filed. For Self-Declaration of Conformity (SDoC) items, records must be maintained and publicly disclosed. Changes to conformity criteria must be...

On August 6, 2025, South Korea’s Ministry of Food and Drug Safety (MFDS) announced a proposed partial amendment to the Enforcement Rules of the Digital Medical Products Act. This amendment seeks to establish detailed provisions delegated by the Act, including procedures and criteria for performance certification of digital healthcare devices, the development and implementation of distribution management plans, and the issuance of orders and public disclosure related to the recall, replacement, disposal, or suspension of sales. Organizations or individuals wishing to provide feedback on the proposed amendment may submit their comments online via the Integrated Legislative Notice System or in writing to MFDS by September 15, 2025. This rule will take effect on the date of its promulgation. For more information, please refer to the link:  Legislative Notice: Proposed Partial Amendment to the Enforcement Rules of the Digital Medical Products Act in South Korea GCA Korea provi...

On August 1, 2025, the Korean Agency for Technology and Standards (KATS) revised the safety standards for sports protective helmets to correct interpretation errors made during the adoption of international standards and to align terminology and specifications with global requirements. Key Amendments Unified the terminology used in the four parts of “protective helmets.” Part   1 is Protective helmets for bike   &   roller sports users, Part   2 is Protective helmets for mountaineers, Part   3 is Protective helmets for skiers, and Part   4 is Protective helmets for baseball. Corrected the misclassification of model types to match international standards. The classification of Type   A and Type   B models has been updated in accordance with EN   1077. Updated the headform specifications to reflect the latest standards. Added a requirement to indicate head size on product labeling. This notification will take effect six months after the date of its announcement. GCA...

Effective August 1, 2025, South Korea’s amended Enforcement Rule of the Medical Device Act will require implantable devices with frequent or potentially serious adverse events to be formally designated for mandatory long-term follow-up. The revision introduces a framework for the systematic collection, analysis, and evaluation of real-world data (RWD) generated during the use of these devices, sets out the criteria the Minister of Food and Drug Safety must apply when making designations, and authorizes the Korea Medical Device Safety Information Center to carry out the related tasks. Key Points Defines criteria for designating devices that require long-term follow-up studies Empowers the Korea Medical Device Safety Information Center to collect, analyze, and evaluate RWD Provides a legal basis for the Center to recruit physicians and dentists for follow-up participation Specifies the RWD that participants must submit, including the date and details of device use and any associate...