SEOUL, February 2026 — The Ministry of Food and Drug Safety (MFDS) has formally published the updated Medical Device GMP Regulations, marking a significant overhaul in how medical devices are manufactured, imported, and monitored in South Korea. These regulations, effective throughout 2025 and 2026, introduce specialized standards for digital health and artificial intelligence while harmonizing more closely with global audit standards.
OVERVIEW OF THE 2026 GMP FRAMEWORK
The new regulatory package is comprised of four primary pillars, each with specific enforcement dates and mandatory compliance modules:
- Enforcement Rule of the Medical Devices Act: The foundational law governing classification, business approvals, and quality manager qualifications.
- General Standards for Good Manufacturing Practice: Standard requirements for traditional medical hardware.
- GMP for In Vitro Diagnostic (IVD) Medical Devices: Specialized standards for diagnostic reagents and equipment.
- GMP for Digital Medical Devices: A brand-new module dedicated to medical software and AI-enabled technologies.
MEDICAL DEVICE GMP REGULATIONS: CRITICAL DEADLINES FOR MANUFACTURERS
This publication serves as a consolidated guide to the Medical Device GMP Regulations. It includes specific GMP guidelines and standards that were formally enacted and began enforcement throughout 2025, even though the manual itself was compiled and released in February 2026. The MFDS has established a phased rollout. Failure to comply with these GMP guidelines by the established dates will result in devices being out of legal compliance:
- April 21, 2025: Mandatory use of the Digital Medical Device GMP module begins for software and AI-based products.
- August 12, 2025: Updated standards for In Vitro Diagnostics come into force.
- October 31, 2025: Formal enforcement of the overarching Medical Devices Act Enforcement Rules.
- December 9, 2025: Deadline for compliance with the updated General Manufacturing Standards.
IMPACTED MODULES: WHAT IS CHANGING?
- The Digital and AI Revolution
For the first time, standalone software and AI-enabled devices have a dedicated GMP path under the Medical Device GMP Regulations. Manufacturers must now pass an “AI Control” assessment, which scrutinizes algorithm transparency, data de-identification, and cybersecurity measures, in line with the new GMP guidelines. - Actor & Quality Manager Registration
Every manufacturing site must assign at least one Quality Manager who meets strict educational and experience criteria. These individuals are now required to complete 8 hours of mandatory annual training to maintain their certification under the Good Manufacturing Practice framework. - Global Harmonization via MDSAP
In a major win for international exporters, the MFDS now officially recognizes the Medical Device Single Audit Program (MDSAP). Manufacturers holding a valid MDSAP certificate may qualify for document-only reviews, potentially bypassing redundant on-site inspections, in compliance with Good Manufacturing Practice standards. - Real-World & Market Surveillance
Oversight no longer ends at the factory gate. The new Post-Marketing Surveillance (PMS) module requires periodic safety reporting every 6 months in the first year of a product’s launch. High-risk or implantable devices, including In Vitro Diagnostic Medical Devices, are also subject to Long-term Follow-up requirements to track real-world adverse events for years.
RESOURCES FOR MANUFACTURERS
To ensure a smooth transition, the MFDS and designated audit organizations have provided the following tools:
- GMP Product Group Classification Guide: Annex 3 for hardware and Annex 5 for digital devices.
- UDI Management Standards: Mandatory guidelines for assigning and registering Unique Device Identification codes in the integrated system.
- Compliance Checklist: Specialized forms for initial, additional, and periodic assessments (Form 1).