Regulatory readiness for medical devices in South Korea

Competent authority: Ministry of Food and Drug Safety (MFDS, formerly KFDA). Core statutes: Medical Devices Act (enacted 2003; repeatedly amended, with major consolidated updates through 2024) and its Enforcement Decree and Rule; for in vitro diagnostics, the In Vitro Diagnostic Medical Devices Act (effective May 2020) with separate Enforcement Decree/Rule. Key implementing notices cover KGMP, UDI, labeling, vigilance, and distribution. Specialized programs include the Special Act on Fostering and Supporting Innovative Medical Devices (effective 2020) that establishes innovative device and company designations with priority or conditional reviews. Industry engagement commonly occurs via the Korea Medical Devices Industry Association (KMDIA). Regulated businesses (manufacturers and importers) must designate an RA responsible manager who meets MFDS training requirements. Foreign manufacturers cannot hold device licenses directly; they must appoint a Korean Importer or License Holder that secures item approvals and manages vigilance and distribution compliance.

MFDS applies a risk-based classification: Class I (lowest) to Class IV (highest). Most noninvasive accessories are Class I; many general active and nonactive devices are Class II; implantables, life-supporting, and long-term invasive devices trend to Class III–IV. Korea uses KMDN (Korean Medical Device Nomenclature) codes mapped to class and applicable standards; correct KMDN selection drives the route (notification, third‑party certification, or MFDS approval). Borderline and combination products are coordinated across MFDS divisions; software as a medical device is classified by intended use and risk, with cybersecurity and lifecycle evidence expected. In vitro diagnostics follow the separate IVD Act with Grades 1–4 by public health risk. Certain IVDs (e.g., infectious disease diagnostics) require designated performance evaluation at MFDS-recognized institutions. Classification also influences KGMP timing (e.g., deferral options for some Class II) and UDI deadlines, as well as post‑market tracking for implantables.

Routes depend on risk and novelty. Class I: notification to MFDS by the Korean License Holder via e-submission; no technical review. Many Class II: third‑party certification by MFDS-designated certification bodies, supported by type testing at MFDS/KFDA‑certified test laboratories (e.g., electrical safety, EMC) and technical documentation; MFDS issues the item license on the basis of certification. Class III–IV and novel devices: MFDS technical review and approval. Dossiers typically include device description and intended use; KMDN/class rationale; standards list; risk management; biocompatibility (ISO 10993); electrical safety/EMC; software lifecycle validation (IEC 62304) and usability (IEC 62366) where applicable; sterilization and shelf life; clinical evaluation or clinical data if required; manufacturing information; labeling/IFU in Korean; and equivalence rationale when used. For certain IVDs, designated performance evaluation reports are mandatory. Innovative devices under the 2020 Special Act may receive priority or conditional review with real‑world evidence commitments. The Korean Importer/License Holder holds the item license and must also possess a Medical Device Import Business License and an RA responsible manager. Clinical investigations in Korea require MFDS and IRB approvals and compliance with Korean GCP. Local testing is often required even when foreign reports exist, though harmonized IEC/ISO reports from accredited labs may reduce repeats.

Korea Good Manufacturing Practice (KGMP) is closely aligned to ISO 13485:2016 but requires site-specific certification by MFDS or MFDS-designated auditors. Certification is typically valid for three years, is tied to each manufacturing site on the item license, and is mandatory for Class II–IV (Class I generally exempt). For first approvals, MFDS often requires completion of KGMP before license issuance for Class III–IV; a deferral may be possible for some Class II with submission within a defined post‑licensing window. Audits are risk-based and may include on‑site or remote evaluations; they expect robust management responsibility, design and change control, production and process validation, supplier control, complaint handling, vigilance interfaces, distribution controls, and record retention. An RA responsible manager must be designated by the Korean Importer/License Holder and maintain MFDS‑recognized training. MDSAP is not formally accepted as a substitute; ISO 13485 certificates and prior audit reports may inform scoping but do not replace KGMP. Ensure alignment of DHF/DMR/DHR, process validations, and Korean distribution traceability with KGMP clauses.

MFDS is rolling out Unique Device Identification (UDI) in phases. By 2024, high-risk and implantable devices (Class III–IV) must bear UDI carriers and submit master data to the MFDS UDI database; remaining classes follow per MFDS notices. UDI includes DI and PI elements and must appear in human-readable and AIDC formats per device and packaging level. Labeling must be in Korean and include device name and model, item license number, manufacturer and Korean Importer/License Holder details, UDI, lot/serial, manufacturing and expiry dates as applicable, storage conditions, warnings/precautions, and instructions for use; IVD labels must state specimen type, measuring units, performance limits, and intended user. E‑IFU is permitted for specified device categories under conditions defined by MFDS. Electrical devices must meet Korean EMC/safety mark requirements evidenced by test reports from KFDA/MFDS‑certified laboratories. Advertising and promotional claims must match licensed indications and be in Korean. Maintain strict version control to keep Korean content synchronized with the licensed dossier.

Manufacturers and Korean Importers/License Holders must operate PMS proportional to risk. Adverse events are reportable to MFDS via the national vigilance system within defined timelines: serious public health threats and deaths typically within 7 calendar days of awareness; other reportable events within 15 days; updates and final reports per MFDS instruction. Field Safety Corrective Actions (FSCA) require immediate notification to MFDS and customers, with recall classification and completion reporting; implantables may require patient tracking. Significant changes to design, intended use, indications, materials, sterilization, software, or manufacturing site/processes require prior MFDS approval or certification update; minor changes may be reportable post‑implementation. Some innovative or newly approved devices are subject to re‑examination within defined years post‑approval and periodic safety reporting. Distributors must maintain storage/transport controls and traceability per Korean GDP expectations. Maintain complaint handling, trend analysis, and CAPA integration to proactively manage risk and compliance.

Days 0–30: Select and contract a Korean Importer/License Holder; confirm they hold an Import Business License and an RA responsible manager with current MFDS training. Map product KMDN, class, and route (notification, third‑party certification, or MFDS approval). Launch a KGMP gap assessment against your ISO 13485 QMS, including supplier control and Korean distribution interfaces. Freeze intended use and indications for Korean translation alignment. Days 30–90: Assemble the technical file (STED‑like) with risk management, biocompatibility, electrical/EMC, sterilization, software validation, usability, clinical evidence as applicable; commission any required local testing at KFDA/MFDS‑certified labs; prepare Korean labeling/IFU; configure UDI DI/PI and packaging hierarchy; plan PMS and vigilance procedures with Korean timelines. Initiate KGMP certification for each manufacturing site (or, if eligible Class II, plan deferral). Days 90–150: Submit Class I notification, Class II third‑party certification, or Class III–IV MFDS application; respond to RFI within set windows; complete KGMP audit activities; finalize UDI data for submission; validate distribution and traceability processes. Days 150–180: Close audit findings and CAPA; lock change control; train commercial and service teams; prepare launch materials compliant with licensed indications; schedule re‑examination or post‑market commitments. For innovative devices, consider applying for designation to access priority or conditional review.