South Korea Quasi Drug Registrations
South Korea has one of the most established and highly regulated consumer healthcare markets in Asia, creating strong opportunities for international manufacturers of quasi-drugs and hygiene-related healthcare products.
Quasi-drugs in Korea occupy a unique regulatory category positioned between cosmetics and pharmaceuticals. Products in this category typically provide mild pharmacological, preventive, disinfecting, sanitary, or hygiene-related functions and are regulated by the Ministry of Food and Drug Safety (MFDS).
Cisema supports foreign manufacturers throughout the entire Korean quasi-drug registration process, from initial feasibility assessment and classification through MFDS submission, Korean labeling, import coordination, and ongoing lifecycle compliance.
According to an MFDS report issued in April 2025, 659 quasi-drugs were successfully registered for the Korean market. While approval and notification volumes have normalized following the temporary COVID-19 surge, the Korean market continues to offer strong opportunities for overseas manufacturers seeking stable regulatory conditions and reduced competitive pressure.
Successful market entry into Korea requires accurate product classification, a clear MFDS registration strategy, compliant Korean-language documentation, and reliable local regulatory support. Depending on the product category and formulation, quasi-drugs may follow either a simplified notification pathway under Korean Standard Manufacturing Standards or a full MFDS approval process requiring individual review.
South Korea Quasi Drug Registration Services
We guide you through every step of quasi-drug registration in Korea. We assess your product category, identify the correct MFDS pathway, prepare the required documentation, and support communication with Korean authorities and relevant import bodies.
Regulatory Strategy & Classification
Technical Documentation & Dossier Preparation
Notification & Approval Applications
Import & Market Entry Support
Post-Approval & Lifecycle Support
Local Authorized Representative Services for Quasi Drugs in Korea
Foreign manufacturers of quasi-drugs entering the South Korean market must work with a locally established Korean entity, known as the Korea License Holder (KLH) to manage MFDS registration, importation, regulatory communication, and lifecycle compliance. This local license holder acts as the manufacturer’s in-country regulatory representative and is responsible for ensuring that the registered product continues to meet Korean requirements after approval or notification.
For overseas manufacturers, the KLH is not simply an administrative contact. It plays a central role in maintaining access to the Korean market and may control product registrations, regulatory filings, import documentation, and communications with MFDS and other relevant Korean bodies.
While appointing a distributor as the local license holder may appear convenient, it can create long-term limitations around certificate control, distributor changes, confidentiality, and commercial flexibility. Many manufacturers therefore prefer to appoint an independent regulatory partner to help maintain control over registrations while keeping distribution options open.
As your independent Korean license holder and regulatory partner, Cisema supports quasi-drug registration, MFDS communication, import coordination, labeling compliance, and lifecycle maintenance, helping you enter and remain in the Korean market with greater transparency, flexibility, and control.
Korea Legal Representation
Regulatory Coordination
Regulatory Compliance
Post-Market Vigilance
Regulatory Strategy
Global Communication
Why Work with Cisema?
One Partner, Full Lifecycle Support
From pre-market strategy to post-market compliance, we provide support to internal regulatory teams and ensure seamless lifecycle management.
Regional Reach, Global Presence
Based in Asia and Europe with a global team delivering global reach.
Cross-Industry Expertise
Pharma, biotech, medical devices, cosmetics, supplements, veterinary, industrial and consumer goods.
Proven Results
Over 20 years of regulatory submissions, regulatory expertise, and approvals to drive business success.
