Cisema Expands into South Korea

We are pleased to announce the expansion of Cisema's regulatory affairs services into South Korea. With a local team now in place, we are supporting foreign manufacturers with medical device, IVD, and quasi-drug registration, KGMP compliance, and ongoing market access across the Korean market.

Why South Korea

South Korea is one of Asia's most advanced healthcare and medical technology markets, with strong and growing demand for innovative medical devices, diagnostics, digital health solutions, and quasi-drug products. As MFDS requirements continue to evolve, having dedicated local regulatory support has become essential for successful market entry and long-term compliance.

What We Offer

Our Korea services cover the complete product lifecycle — from initial regulatory strategy and product classification through to MFDS submission, KGMP coordination, labeling localisation, post-market surveillance, and ongoing compliance management.

Specifically, we support manufacturers with:

• Medical Device and IVD Registration — product classification, dossier preparation, and full MFDS submission management
• Quasi-Drug Registration — regulatory classification, dossier preparation, importer coordination, labeling compliance, and submission support
• Korea License Holder (KLH) Services — local license holder representation, giving foreign manufacturers a compliant presence while retaining full control of their registrations
• KGMP Compliance Support — readiness assessments, gap analysis, and factory inspection preparation
• Regulatory Strategy and Submission Management — proactive MFDS planning, change notifications, labeling localisation, and post-market surveillance

All services are delivered independently, so manufacturers maintain full flexibility and control over their registrations and distribution strategies.

Part of Our Broader Asia Pacific Offering

This expansion builds on more than 20 years of regulatory experience across Asia Pacific. South Korea joins our existing network of markets where we support manufacturers of medical devices, IVDs, cosmetics, supplements, and healthcare products with registration, compliance, and market access.

Learn more about our South Korea quasi-drug services and our medical device & IVD services or get in touch to discuss how we can support your market entry and compliance needs.

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