Korea KC Certification | GCA

On July 31, 2025, South Korea’s Ministry of Food and Drug Safety (MFDS) released a draft partial amendment to the Enforcement Rule of the In Vitro Diagnostic Medical Devices Act, scheduled to take effect on January 3, 2026. The draft outlines delegated matters such as performance evaluation criteria and methods, application procedures, and task entrustment. It aims to clarify evaluation standards and establish provisions for administrative actions based on the results of such evaluations. Main Contents of the Draft Amendment Performance evaluation: Evaluations will be conducted by the standards under the Medical Device Act and the detailed criteria and methods established by the MFDS Commissioner. Application procedures: Applicants must submit technical documents, specimens, and reference materials to an entrusted institution. The institution will report the results to both the applicant and the MFDS Commissioner, and fees may be charged after being publicly disclosed in advance....

The amended rules will take effect on August 14, 2025, following a draft amendment announced by the Ministry of Land, Infrastructure and Transport (MOLIT) on July 29, 2025. The amendment to the Rules on Standards and Procedures for Administrative Dispositions under Article 21(2) of the Automobile Management Act introduces a vehicle cybersecurity management system certification scheme and sets clear criteria and procedures for revoking or suspending certification. It addresses the growing need for secure software updates and stronger cybersecurity as vehicles become more software-driven and connected. Key Points New criteria for revocation and suspension of certification: define the grounds for cancelling or suspending a vehicle cybersecurity management system certification. Detailed penalty periods in Annex 2: specify suspension or cancellation periods based on the number of violations. Opinions on the draft amendment may be submitted by August 7, 2025, either online via the ...

On July 28, 2025, South Korea’s Ministry of Food and Drug Safety (MFDS) announced the reissue of a partial amendment to the Enforcement Rule of the In Vitro Diagnostic Medical Devices Act. The amendment aims to improve the quality and infrastructure of newly developed in vitro diagnostic medical devices (IVDs) and address gaps in the current system. Key Changes Approval fees for new IVDs will be revised, with provisions for fee reductions. Applicants for manufacturing licenses or modifications will be exempt from resubmitting verified quality manager qualification documents. Packaging of personal blood glucose test strips must indicate the period of use after opening. The Class I IVD management system will move to a notification-based process with a five-day processing period. Institutions, organizations, and individuals may submit opinions on the amendment online or by sending a written statement to MFDS by September 8, 2025. For inquiries about South Korea’s regul...

South Korea’s National Radio Research Agency (RRA) announced on July 25, 2025, its plan to enact, revise, and repeal national standards in the broadcasting and communications sector. Proposed Enactment of Standards (3 of 11) Guidelines for Intrusion Prevention Systems in Connected Vehicles: This standard presents IDS-based methodologies to address the limitations of traditional in-vehicle detection systems in Ethernet-based vehicle networks. EMC Test Methods for Ultra-Wideband (UWB) Wireless Devices: Based on ETSI EN 301 489-33, it outlines test methods to protect communication services from emissions generated by UWB devices such as Ground Penetrating Radar (GPR) and object detection sensors. EMC Test Methods for Fixed Satellite Earth Stations: Based on ETSI EN 301 489-12, this standard provides EMC testing procedures for low Earth orbit satellite ground stations introduced in South Korea. Proposed Revision of Standards (2 of 9) KS X 3036 (Ground Resistance Measurement for ...

On July 23, 2025, South Korea’s National Radio Research Agency (RRA) issued a draft amendment to the “Notification on Conformity Assessment of Broadcasting and Communication Equipment.” The proposed changes aim to address operational challenges arising from the introduction of the Supplier’s Declaration of Conformity (SDoC) system and the reorganization of equipment classifications. The amendment also reflects efforts to improve regulatory clarity by simplifying terminology and refining ambiguous provisions. Key updates include establishing a legal basis for identification code applications, clarifying procedures for composite equipment that combines certified devices, and correcting labeling requirements. The draft also proposes updates to EMC-related definitions, reclassification of certain equipment types, clearer exclusion criteria for industrial-use devices, and revised classifications for headend and in-building communication systems. Stakeholders are invited to submit commen...

The amended Enforcement Decree of the Medical Device Act took effect upon promulgation on July 22, 2025. Provisions related to processing personal information will come into force on August 1, 2025. The amendment provides a legal basis for Korea’s Minister of Food and Drug Safety (MFDS) and local governments to process sensitive and personally identifiable information when necessary to collect, analyze, and evaluate real-world data generated during the use of certain medical devices. This change follows a revision to the Medical Device Act that enables the designation of devices requiring long-term follow-up due to frequent or serious adverse effects after insertion into the human body. Personal information may also be processed when responding to adverse events, including reporting, recall, and notification involving patients who have used the relevant devices. For any inquiries regarding medical device certification in South Korea, don’t hesitate to reach out to GCA KOREA. O...

On June 23, 2025, South Korea’s National Radio Research Agency (RRA) issued a notification revising the technical standards for maritime radio equipment. This amendment aims to enhance maritime safety by eliminating outdated provisions and harmonizing Korea’s standards with international regulations. The revision took effect immediately, and equipment certified or authorized under previous rules remains valid. Key Highlights: Relaxed SAR Transmitter Requirements:  Technical requirements for Search and Rescue (SAR) location transmitters have been eased and clarified with diagrams, aligning them with international standards. EPIRB AIS Support Mandated: Satellite Emergency Position-Indicating Radio Beacons (EPIRBs) are now required to support the Automatic Identification System (AIS). Clear Occupied Bandwidth Specifications for Ship Stations: Occupied bandwidths are now clearly defined as 16   kHz for 25   kHz channel spacing and 8.5   kHz for 12.5   kHz spacing. ITU Compliance fo...