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Showing posts from August, 2025

Stricter password requirements are going to be implemented for IP cameras

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Stricter password requirements are going to be implemented to image information processing devices(including IP cameras) on Feb. 20, 2026. The password required for image information processing devices shall meet the following conditions: The password shall consist of at least 8 characters using a combination of 3 types among uppercase letters, lowercase letters, numbers, and special characters, or at least 10 characters using a combination of 2 types. If the password is entered incorrectly a certain number of consecutive times (up to 5 times), access shall be blocked for a certain period of time (30 seconds to 60 minutes). GCA Korea provides expert support for global companies navigating South Korea’s regulatory requirements. Our specialties include  KC EMC ,  KC Safety ,  KC Energy Efficiency ,  KC Automotive Components ,  KCsEx (ATEX, IECEx) , or  MFDS (Korean Medical Devices) . For tailored certification and regulatory assistance, contact GCA Korea. We’...

KC Energy Efficiency Management Regulation has been revised and is scheduled to be implemented soon

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For the purpose of achieving energy savings through strengthening item-specific standards and expanding the scope of equipment subject to energy efficiency management as part of improving the energy efficiency management system, the regulation on the operation of energy efficiency management equipment is scheduled to be revised as follows. The following content is scheduled to be implemented soon after collecting public opinions until September 10. Item Key details Expected date of implementation Fan -Expansion of application scope(addition of circulators and BLDC) -Upgrading of efficiency grades and minimum energy performance standards(MEPS) 2027.1.1 Clothes dryer Upgrading of efficiency grades and minimum energy performance standards(MEPS) 2026.10.1 Household gas boiler -Efficiency grades -> minimum standards -Upgrading of minimum energy performance standards (MEPS) 2026.10.1 Air fryer New one of energy efficiency management equipment(efficiency grade) 2027.1.1 Printer New one o...

South Korea Updates Industrial Standards for Medical Products

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Establishment of 25 Standards (Ministry of Food and Drug Safety (MFDS) Announcement No. 2025-347) • KS X NEW 2025 2602: Health software and health IT systems safety, effectiveness and security — Part 5-1: Security — Activities in the product life cycle • KS C NEW 2025 4600: Medical electrical equipment - Part 4-5: Guidance and interpretation - Safety-related technical security specifications • KS P NEW 2025 2303: Medical devices — Connectors for reservoir delivery systems for healthcare applications - Part 1: General requirements and common test methods Revision of 77 Standards (MFDS Announcement No. 2025-348) KS C IEC 60601-1-12: Medical electrical equipment — Part 1-12: General requirements for basic safety and essential performance — Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment Abolition of 7 Standards (MFDS Announcement No. 2025-349) KS P ISO 16971...

South Korea Sets New Safety Standards for Portable Ethanol Fireplaces

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This regulation will take effect one year after its promulgation. On August 26, 2025, the Korean Agency for Technology and Standards (KATS) announced new safety standards for portable ethanol fireplaces to help prevent fires and injuries. Widely used for camping and home decoration, these products are valued for their convenience as they require no electricity or gas. However, from 2022 to June 2025, 40 fires and 12 injuries were reported. Many of these incidents occurred when users refueled under the mistaken belief that the flame was extinguished while a residual flame remained, or when the unit toppled during use and spilled fuel ignited. The new standards require proper fuel filling and ignition devices, stability features to prevent tipping, and surface temperature limits by material. Portable ethanol fireplaces will now be managed as consumer products subject to compliance with safety standards under the Electrical Appliances and Consumer Products Safety Control Act. ...

South Korea Designates Long-term Follow-up Medical Devices

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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. Our s...

Korea's Vehicle Cybersecurity Regulations Took Effect on August 14

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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...

Automotive Cyberattacks Could Lead to Vehicle Operation Restrictions in South Korea

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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...

Are You Aware of Conformity Assessment Violations in South Korea?

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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...

Digital Medical Products in South Korea Face New Compliance Requirements

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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...

Protective Helmets Newly Regulated to Reflect Latest Standards in South Korea

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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...

South Korea Sets Criteria for Designating Medical Devices Requiring Long-Term Follow-Up Studies

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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...