South Korea – MFDS Regulatory Landscape

Regulatory Framework and Stakeholders

In South Korea, medical devices fall under the authority of the Ministry of Food and Drug Safety (MFDS). The system covers a wide range of stakeholders, from manufacturers to distributors, with a particular focus on foreign companies appointing a local Authorized Representative (Importer). This representative plays a critical role, handling submissions, labeling, recalls, and post-market safety reporting on behalf of the manufacturer.

Classification and Registration

Devices are classified into four risk classes:

• Class I – low risk, reviewed by NIDS.
• Class II – reviewed by designated notified bodies.
• Class III & IV – higher-risk devices, reviewed by MFDS or NIFDS.

In addition to product registration, KGMP (South Korea Good Manufacturing Practice) certification is required. Any site involved in design, assembly, sterilization, packaging, quality control, or shipment must hold KGMP certification. Subcontractors performing these functions are also required to comply. Certification is typically valid for three years, but facilities recognized as “excellent” may extend the cycle to six years. KGMP is closely aligned with ISO 13485, with only minor local adaptations.

Product Certificate and Technical Documentation

To obtain a product license, manufacturers must submit technical documentation covering safety, performance, biocompatibility, and electromagnetic compatibility. Devices that involve software must also meet cybersecurity documentation requirements, as clarified in MFDS Notification No. 2023-80. Clinical evidence may be required for higher-risk products, and in certain cases, MFDS allows the use of international testing reports (e.g., ISO, IEC) if equivalent.

Regulatory Updates

South Korea has introduced several changes to modernize its system:

• Digital Health: Clearer definitions and pathways for digital healthcare products.
• Fast-Track Approvals: A regulatory route for innovative technologies to reach the market sooner.
• Extended KGMP Cycles: Inspection intervals lengthened to six years for high-performing facilities.
• Adverse Event Reporting: Contact details must be included in device documentation, with reporting timelines set based on severity.
• Implantable Devices: A new legal framework introduces post-market tracking requirements.

These changes reflect South Korea's intent to encourage innovation while maintaining strict oversight of safety and quality.