Korea’s medical device regulatory framework is undergoing one of its most significant transformations in recent years. With the introduction of MFDS Notice 2026-6, the Ministry of Food and Drug Safety has comprehensively revised the Regulation on Medical Device Approval, Notification, and Review moving decisively toward international alignment, operational consistency, and regulatory transparency.
Importantly, Notice 2026-6 did not arrive in isolation. In February 2026, MFDS simultaneously published updated Medical Device GMP Regulations, strengthening regulatory expectations across the entire device lifecycle from design and manufacturing through post-market surveillance and regulatory inspections. Together, Notice 2026-6 and the updated KGMP framework represent a coordinated regulatory modernization effort that manufacturers entering or already operating in Korea must understand holistically.
For manufacturers, these updates reshape how companies prepare submissions, document technical files, manage software and AI-enabled devices, and maintain KGMP compliance throughout the product lifecycle. This article provides a detailed comparison of previous and updated requirements under Notice 2026-6 and explains what they mean in practical terms.
Why MFDS Introduced Notice 2026-6
Before this revision, Korea’s regulatory system faced persistent structural challenges: reviewer interpretation varied, documentation expectations lacked consistency, and emerging technologies, particularly software-based and AI-enabled devices, were insufficiently addressed. These gaps created uncertainty and prolonged review timelines for manufacturers.
The timing of Notice 2026-6 also reflects Korea’s broader strategic ambitions. South Korea is experiencing one of the world’s most rapid aging populations, entering super-aged society status in 2025 when the population aged 65 and over exceeded 20%. The home medical device market is projected to grow from approximately 6 trillion won in 2019 to approximately 15 trillion won by 2025, driving significant demand for diagnostic, monitoring, and chronic disease management devices. A modernized regulatory framework is essential infrastructure for sustaining this growth and for attracting the global manufacturers needed to serve it.
Clearer Definitions and Device Categorization
Previous Framework
Under the previous system, device categorization was only partially harmonized with international standards. Important distinctions, such as those between combination products, integrated systems, components, and accessories, were often open to interpretation.
Software-based technologies were particularly affected, as they lacked consistent classification rules and were frequently evaluated on a case-by-case basis.
Updated Requirements
Notice 2026-6 introduces standardized, IMDRF-aligned definitions that bring greater clarity and consistency to device classification.
The revised framework:
- Clearly differentiates between combination, integrated, and single-use devices
- Establishes explicit criteria for components and accessories
- Formally defines Software as a Medical Device (SaMD)
- Standardizes new device classification rules
As a result, manufacturers can now approach classification with greater confidence and fewer regulatory uncertainties.
Notice 2026-6 introduces IMDRF-aligned definitions that bring greater clarity and consistency to device classification. The revised framework differentiates between combination, integrated, and single-use devices; establishes explicit criteria for components and accessories; formally defines SaMD; and standardizes new device classification rules.
A practical addition for foreign manufacturers: all Class II–IV applications must include a comparison table to a substantially equivalent device registered with MFDS. Devices without a Korean market predicate require clinical data and will undergo Clinical Data Review (CDR). Notice 2026-6’s clearer classification rules make it easier to identify appropriate Korean predicates earlier in the submission process, reducing the risk of late-stage discovery that CDR is required.
Strengthened Oversight of Software as a Medical Device (SaMD)
Under Notice 2026-6, software regulation has been substantially strengthened, providing a formal IMDRF-aligned SaMD definition, explicit regulatory treatment of AI-driven functionality, defined requirements for data transmission and storage, standardized software documentation structures, and clear differentiation between embedded and standalone software.
These Notice 2026-6 updates should be read alongside the Digital Medical Products Act (DMPA) framework, now fully in effect as of January 24, 2026. The DMPA covers definitions related to digital medical devices, classification, authorization, clinical trials, manufacturing and quality control, electronic infringement security, and labeling with new labeling requirements for digital medical device software under Article 22 and requirements for digital medical/health support devices under Articles 33 to 35 now active. Manufacturers of digital health products must ensure compliance with both Notice 2026-6 and the DMPA framework simultaneously.
Mandatory IMDRF STED Technical Documentation
Notice 2026-6 makes the IMDRF STED format mandatory for applicable submissions, introducing a uniform structure for technical files, clear expectations for safety and performance evidence, harmonized risk management and usability documentation, and enhanced labeling and packaging standards.
A practical note for foreign manufacturers: most application documents must be submitted in Korean or in dual-language format. Korean in-country representatives (ICRs) often provide standardized templates for declarations, process charts, and interrelationship diagrams, using these can improve clarity and alignment with reviewer expectations. Manufacturers building STED-compliant technical files for Korea should factor Korean-language preparation into their project timelines from the outset, not as a final translation step.
Harmonized Performance and Safety Testing Standards
The revised regulation introduces harmonized testing protocols aligned with global benchmarks, including defined mandatory testing criteria, expanded software validation requirements, standardized biocompatibility and electrical safety protocols, and clearer clinical evaluation expectations.
These testing harmonization changes work in concert with the February 2026 KGMP update: manufacturing quality under the new KGMP framework is no longer assessed independently of market performance data, reflecting a lifecycle approach where testing and production quality are evaluated together. Manufacturers should ensure their testing documentation aligns with both Notice 2026-6 submission requirements and the updated KGMP quality management expectations.
Formalized Pre-Submission Review Procedures
Notice 2026-6 establishes a structured pre-submission framework with clearly defined procedural steps, standardized documentation requirements, transparent eligibility criteria, predictable review timelines, and consistent documented feedback.
For manufacturers new to the Korean market, proactive engagement with this pre-submission framework is strongly recommended, particularly for novel, AI-enabled, or hybrid devices where classification uncertainty exists. MFDS continues to update its regulations and guidelines related to approvals to reflect advancing technologies, and pre-submission engagement allows manufacturers to understand current reviewer expectations before committing to a full submission strategy. For AI/ML-based devices, clinical validation data plays a central role in regulatory approval in Korea, more so than in some other jurisdictions, making early alignment on evidence expectations especially important.
Streamlined Approval and Certification Pathways
The revised framework simplifies market entry pathways by clarifying procedures for innovative and hybrid products, expanding exemption categories, defining boundaries between approval and certification, and establishing standardized review timelines.
KGMP certification, a mandatory prerequisite for Class II, III, and IV device registration, typically takes 2–3 months from submission once the on-site or document audit is complete, though this can extend if auditors raise queries or manufacturers need additional time to address non-conformities. Manufacturers should treat KGMP certification as a parallel work stream to Notice 2026-6 submission preparation, not a sequential one as KGMP delays are one of the most common causes of extended time-to-market in Korea.
Improved Change Management and Notification Requirements
Notice 2026-6 introduces structured lifecycle management requirements with clear re-notification triggers, defined manufacturer and distributor responsibilities, standardized notification documentation, formal change control reporting systems, and enhanced compliance monitoring.
For AI/ML-based device manufacturers, the change management framework has an important DMPA-specific dimension: the DMPA allows pre-approved change management plans that enable companies to update AI algorithms without full re-approval, as long as updates remain within pre-approved parameters. Significant changes that could impact patient safety still require additional regulatory review. Manufacturers of AI-enabled devices should build their change management systems to accommodate both Notice 2026-6 notification requirements and DMPA algorithm change management plan obligations simultaneously.
Standardized Inspection and Verification Procedures
Notice 2026-6 establishes unified inspection protocols including standardized evaluation criteria, uniform certificate formats, transparent reporting processes, defined corrective action timelines, and risk-based inspection frequencies.
The February 2026 KGMP update adds critical inspection-specific detail: on-site inspections remain a key component of KGMP certification, particularly for higher-risk devices. For implantable and higher-class devices, MFDS may conduct more detailed audits focusing on risk management integration within manufacturing controls, evaluating not only compliance with documented procedures but also the effectiveness of implementation in practice.
Supplier qualification systems must include regular evaluation, defined quality agreements, and performance monitoring. MFDS inspections increasingly review supplier oversight as a core compliance area, manufacturers relying on complex international supply chains should anticipate additional scrutiny.
A key distinction for foreign manufacturers: ISO 13485 certification alone is no longer sufficient for smooth market entry into Korea. KGMP certification requires formal MFDS supervision and is distinct from ISO 13485, even though it is based on the same standard. For manufacturers that have never undergone an MFDS audit, there is a near 100% likelihood that MFDS will require an on-site audit as part of KGMP certification. Manufacturers holding MDSAP certification may be eligible for a paper-based audit instead, though feasibility depends on several factors and historical success rates are approximately 50%
Clearer Same Product Group Criteria
Previous Framework
Ambiguity surrounding “same product group” definitions often led to inconsistent bundling decisions, especially for software versions and accessory configurations.
Updated Requirements
Notice 2026-6 introduces explicit grouping standards that:
- Define rules for bundling similar devices
- Clarify software version grouping
- Establish accessory classification guidelines
- Reduce reviewer discretion
This improves predictability for multi-product submissions and portfolio management.
Refined New Device Classification Rules
Previous Framework
Criteria for identifying “new devices” were broad and inconsistently applied. Limited examples and guidance made it difficult for manufacturers to anticipate regulatory outcomes.
Updated Requirements
The revised framework establishes:
- Precise thresholds for novelty and innovation
- Supporting examples and case references
- Consistent application across device types
- Special provisions for emerging software technologies
These refinements enable earlier and more accurate regulatory strategy development.
Expanded Pathways for Rare-Disease and Special-Purpose Devices
Previous Framework
Rare-disease and special-purpose devices were subject to narrow eligibility criteria and limited regulatory flexibility, discouraging investment in low-volume markets.
Updated Requirements
Notice 2026-6 expands access through:
- Broader eligibility definitions
- Conditional and expedited approval options
- Flexible review pathways
- Incentives for underserved therapeutic areas
- Clear documentation expectations
This supports innovation in areas of unmet medical need.
Broader and More Transparent Fee Exemptions
Previous Framework
Fee exemptions were rarely granted, and application processes lacked clarity and consistency.
Updated Requirements
The revised regulation formalizes exemption policies by introducing:
- Clearly defined eligibility categories
- Transparent application procedures
- Predictable review timelines
- Incentives for public health and rare-disease devices
These changes reduce financial barriers for qualifying manufacturers.
What These Changes Mean for Manufacturers
Taken together, MFDS Notice 2026-6 and the February 2026 KGMP update signal a decisive move toward a more structured, internationally harmonized, and lifecycle-integrated regulatory environment in Korea. Compliance requirements have become more detailed, but regulatory outcomes are now more predictable.
For manufacturers, this shift emphasizes the importance of early regulatory planning; standardized STED technical documentation; integrated software and AI governance under both Notice 2026-6 and the DMPA; proactive pre-submission engagement; robust lifecycle management systems; and KGMP certification treated as a strategic project, not an administrative step. Manufacturers that strengthen their QMS, supplier control, and post-market systems now will not only meet MFDS expectations, they will be better prepared for global regulatory convergence.
Preparing for Compliance Under Notice 2026-6
To navigate the revised framework effectively, manufacturers should:
Conduct gap analyses against updated STED and SaMD requirements under Notice 2026-6. Revise internal documentation templates to reflect mandatory IMDRF STED format and Korean-language requirements. Strengthen change management processes, including DMPA algorithm change management plans for AI/ML devices.
Enhance software validation and cybersecurity programs to meet both Notice 2026-6 and DMPA obligations. Engage early with MFDS through formal pre-review channels, particularly for novel or AI-enabled devices. Conduct early gap assessments against the updated KGMP requirements, manufacturers of Class III and implantable devices should allocate additional resources to validation documentation, risk management integration, and inspection simulations. Evaluate MDSAP certification status as a potential path to paper-based KGMP audit. Prepare for on-site MFDS inspection if KGMP certification has not previously been obtained.
Conclusion
MFDS Notice 2026-6, together with the February 2026 KGMP update, represents Korea’s most comprehensive medical device regulatory modernization in recent years. By strengthening international alignment through IMDRF standards, formalizing review and inspection procedures, and expanding oversight of digital and AI-enabled technologies, MFDS has created a more transparent and predictable pathway to market, but also a more demanding one.
For foreign manufacturers in particular, the combination of mandatory STED documentation, KGMP certification requirements that go beyond ISO 13485, Korean-language documentation obligations, and the dual Notice 2026-6 and DMPA compliance requirements for digital products demands early, structured preparation. Companies that begin gap assessments and KGMP certification planning now, rather than after a submission is ready, will be best positioned to minimize delays and capitalize on Korea’s significant and growing medical device market opportunity.
FAQ
What is MFDS Notice 2026-6 and what does it cover? MFDS Notice 2026-6 is a comprehensive revision to Korea’s Regulation on Medical Device Approval, Notification, and Review, issued by the Ministry of Food and Drug Safety in early 2026. It covers device classification and definitions (including a formal SaMD definition), mandatory IMDRF STED technical documentation, harmonized testing standards, formalized pre-submission review procedures, streamlined approval pathways, structured change management and notification requirements, standardized inspection procedures, same product group criteria, new device classification rules, expanded rare-disease pathways, and formalized fee exemption policies. The revision aligns Korea’s regulatory framework more closely with IMDRF standards and international regulatory expectations.
Does ISO 13485 certification satisfy Korea’s GMP requirements under the updated framework? No, ISO 13485 certification alone is not sufficient for smooth market entry into Korea. Korea requires formal KGMP certification issued under MFDS supervision, which is distinct from ISO 13485 even though it is based on the same standard. For foreign manufacturers that have never undergone an MFDS audit, there is a near 100% likelihood that MFDS will require an on-site audit as part of KGMP certification. Manufacturers holding MDSAP certification may request a paper-based audit, but feasibility varies and success rates are approximately 50%. KGMP certification should be treated as a separate, parallel work stream to submission preparation.
What are the new SaMD and AI device requirements under Notice 2026-6? Notice 2026-6 introduces a formal IMDRF-aligned SaMD definition, explicit regulatory treatment of AI-driven functionality, defined requirements for data transmission and storage, standardized software documentation structures, and clear differentiation between embedded and standalone software. For AI/ML devices, these requirements must be read alongside the Digital Medical Products Act (DMPA), fully in effect from January 24, 2026, which allows pre-approved change management plans for algorithm updates within pre-approved parameters, while significant changes impacting patient safety still require additional regulatory review.
What does Notice 2026-6 mean for foreign manufacturers specifically? Several elements have particular impact for non-Korean manufacturers. All Class II–IV applications must include a comparison table to a substantially equivalent device registered with MFDS, devices without a Korean market predicate require clinical data and will undergo Clinical Data Review (CDR). Most documents must be submitted in Korean or dual-language format. KGMP certification remains a mandatory prerequisite requiring MFDS-supervised inspection. Supplier qualification systems must include regular evaluation, defined quality agreements, and performance monitoring, supply chain complexity will receive increasing scrutiny during MFDS inspections.
How does Notice 2026-6 relate to the February 2026 KGMP update? The two updates are complementary and should be understood together as a coordinated regulatory modernization effort. Notice 2026-6 governs the approval, notification, and review process: how devices are classified, submitted, and approved. The February 2026 KGMP update strengthens manufacturing oversight, enhances inspection expectations, and integrates manufacturing controls with post-market surveillance in a lifecycle approach — where manufacturing quality is no longer assessed independently of market performance data. Manufacturers should prepare for both simultaneously rather than sequentially, as KGMP delays are one of the most common causes of extended Korean market entry timelines.
