South Korea Medical Device Registration
Unlock the South Korean market with expert regulatory guidance, KGMP compliance support, and an independent local regulatory representative, with Cisema.
We help foreign manufacturers of medical devices, IVDs, and digital medical products navigate the full MFDS registration process, comply with Korean regulatory requirements, and maintain regulatory and quality compliance throughout the entire product lifecycle. As your experienced local regulatory partner, we support your market entry into Korea from initial strategy and device classification through approval and post-market surveillance.
With an experienced local team in South Korea and deep knowledge of the Korean “Medical Device Act,” “IVD Act,” and “Digital Medical Products Act,” Cisema acts as your independent Korean regulatory representative and compliance partner. We provide comprehensive support for MFDS approvals, KGMP conformity assessment, technical documentation, regulatory planning, Korean labeling, UDI compliance, and ongoing lifecycle management.
South Korea is widely recognized as one of the most advanced healthcare and technology markets in Asia, combining sophisticated healthcare infrastructure, strong purchasing power, rapid adoption of innovative technologies, and increasing demand for digital healthcare solutions. Korea has become an especially important market for AI-based medical devices, Software as a Medical Device (SaMD), Digital Therapeutics (DTx), wearable healthcare technologies, advanced IVD solutions, and aesthetic medical devices.
As Korean regulations continue to evolve rapidly, regulatory authorities are placing increasing emphasis on cybersecurity, software lifecycle management, AI governance, post-market surveillance, and quality system compliance. Having an effective MFDS regulatory strategy and strong local regulatory support has therefore become increasingly important for successful market entry and long-term commercial success.
From regulatory pathway assessment and dossier preparation to KGMP coordination, clinical and performance evaluation support, and post-market compliance, Cisema helps simplify your path to market entry in South Korea while giving you long-term flexibility, transparency, and control.
South Korea Medical Device Registration Services
We guide you through every step of medical device registration in Korea. We take care of compliance with MFDS requirements, advising you on the optimal market entry pathway, test methods and helping you through the whole process to achieving your medical device registration certificate.
Regulatory Strategy & Classification
Technical Documentation & Localization Support
Testing, KGMP & Technical Support
Registration Application & Submission
Post-Approval & Lifecycle Support
Local Authorized Representative Services for Korea
All foreign manufacturers of medical devices, IVDs, and digital medical products entering the South Korean market without a physical office in South Korea must appoint a local authorized representative, known as the Korean License Holder (KLH), as their in country representative. The KLH must be a legal entity residing in South Korea and acts as the legal license holder and regulatory liaison before the Ministry of Food and Drug Safety (MFDS) throughout the entire product lifecycle.
For overseas manufacturers, the KLH is not simply a filing agent. The KLH plays a central role in controlling and maintaining access to the Korean market and is responsible for managing submissions to the MFDS.
While appointing a distributor as KLH may initially appear commercially convenient, it can also create long-term limitations regarding distribution flexibility, certificate control, and intellectual property protection. Many manufacturers therefore prefer working with an independent regulatory partner to maintain greater commercial flexibility and long-term control of registrations.
The KLH compiles the STED and other application files in Korean and submits the completed dossier through the MFDS electronic submission portal.
At Cisema, we act as an independent Korean License Holder (KLH), providing manufacturers with transparent regulatory support while allowing full flexibility in selecting or changing distributors as business needs evolve.
Korea Legal Representation
Regulatory Coordination
Regulatory Compliance
Post-Market Vigilance
Conformity Assessment Bodies Collaboration
Regulatory Strategy
Global Communication
Warum mit Cisema zusammenarbeiten?
Ein Partner, umfassende Unterstützung über den gesamten Lebenszyklus
Von der Strategie vor der Markteinführung bis zur Compliance nach der Markteinführung unterstützen wir interne Zulassungsteams und sorgen für ein nahtloses Lebenszyklusmanagement.
Regionale Reichweite, globale Präsenz
Mit Standorten in Asien und Europa sowie einem globalen Team bieten wir weltweite Reichweite.
Branchenübergreifende Expertise
Pharma, Biotech, Medizinprodukte, Kosmetik, Nahrungsergänzungsmittel, Veterinärprodukte sowie Industrie- und Konsumgüter.
Nachgewiesene Erfolge
Über 20 Jahre Erfahrung mit regulatorischen Einreichungen, Fachwissen und Zulassungen für Ihren geschäftlichen Erfolg.
