Korea’s medical device regulatory framework is undergoing a significant transformation. With the introduction of MFDS Notice 2026-6, the Ministry of Food and Drug Safety has implemented one of its most comprehensive regulatory updates in recent years, revising the Regulation on Medical Device Approval, Notification, and Review.
Rather than serving as a routine procedural update, this notice reflects a broader shift toward international alignment, operational consistency, and regulatory transparency. By strengthening its connection to International Medical Device Regulators Forum (IMDRF) standards, MFDS aims to create a more predictable and globally compatible approval environment.
For manufacturers seeking access to the Korean market, understanding these changes is no longer optional. Classification rules, documentation standards, review pathways, and post-market obligations have all been refined.
Together, these updates reshape how companies prepare, submit, and maintain regulatory approvals in Korea. This article provides a detailed comparison of the previous and updated requirements under MFDS 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. Interpretation often varied between reviewers, documentation expectations were not always consistent, and emerging technologies (particularly software-based and AI-enabled devices) were insufficiently addressed.
These gaps created uncertainty for manufacturers and, in some cases, led to prolonged review timelines and repeated requests for clarification.
MFDS Notice 2026-6 was designed to resolve these issues by:
- Aligning national regulations with IMDRF frameworks
- Clarifying ambiguous definitions and classification criteria
- Standardizing documentation and review procedures
- Improving transparency across approvals, inspections, and notifications
- Supporting innovation through more flexible regulatory pathways
Collectively, these changes aim to strengthen regulatory rigor while reducing unnecessary friction for compliant manufacturers.
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.
Strengthened Oversight of Software as a Medical Device (SaMD)
Previous Framework
Historically, SaMD submissions in Korea were governed by fragmented guidance. Artificial intelligence and algorithm-based functions were not explicitly regulated, while expectations for software updates, cybersecurity, and data management remained unclear.
This lack of consistency made regulatory planning particularly challenging for digital health developers.
Updated Requirements
Under Notice 2026-6, software regulation has been substantially strengthened.
The revised framework now provides:
- A formal, IMDRF-aligned SaMD definition
- Explicit regulatory treatment of AI-driven functionality
- Defined requirements for data transmission and storage
- Standardized software documentation structures
- Clear differentiation between embedded and standalone software
These changes establish a more predictable regulatory environment for digital technologies while reinforcing patient safety and data integrity.
Mandatory IMDRF STED Technical Documentation
Previous Framework
Previously, technical documentation formats varied widely. Although the IMDRF Summary Technical Documentation (STED) model was encouraged, its use was often optional, and safety and performance data were not always presented consistently.
Updated Requirements
Notice 2026-6 makes the IMDRF STED format mandatory for applicable submissions.
This transition introduces:
- A uniform structure for technical files
- Clear expectations for safety and performance evidence
- Harmonized risk management and usability documentation
- Enhanced labeling and packaging standards
By standardizing technical submissions, MFDS has reduced reviewer subjectivity and simplified regulatory preparation for multinational manufacturers.
Harmonized Performance and Safety Testing Standards
Previous Framework
Testing requirements previously differed by device type and reviewer interpretation. International standards were not always applied consistently, and software validation expectations were limited.
Updated Requirements
The revised regulation introduces harmonized testing protocols aligned with global benchmarks, including:
- Defined criteria for mandatory testing
- Expanded software validation requirements
- Standardized biocompatibility and electrical safety protocols
- Clearer clinical evaluation expectations
These updates improve consistency across conformity assessments and reduce approval delays caused by testing discrepancies.
Formalized Pre-Submission Review Procedures
Previous Framework
Pre-review processes were largely informal. Eligibility requirements were unclear, timelines were unpredictable, and feedback quality varied significantly.
Updated Requirements
Notice 2026-6 establishes a structured pre-submission framework that includes:
- Clearly defined procedural steps
- Standardized documentation requirements
- Transparent eligibility criteria
- Predictable review timelines
- Consistent, documented feedback
This allows manufacturers to identify regulatory risks earlier and address them proactively.
Streamlined Approval and Certification Pathways
Previous Framework
Approval pathways often depended on individual reviewer interpretation, particularly for novel and hybrid devices. Exemption criteria were narrow, and review timelines lacked consistency.
Updated Requirements
The revised framework simplifies and standardizes market entry pathways by:
- Clarifying procedures for innovative and hybrid products
- Expanding exemption categories
- Defining boundaries between approval and certification
- Establishing standardized review timelines
These improvements support more reliable regulatory planning and commercialization strategies.
Improved Change Management and Notification Requirements
Previous Framework
Manufacturers frequently faced uncertainty about when design or manufacturing changes required re-notification. Documentation standards varied, and enforcement was inconsistent.
Updated Requirements
Notice 2026-6 introduces structured lifecycle management requirements, including:
- Clear triggers for re-notification
- Defined responsibilities for manufacturers and distributors
- Standardized notification documentation
- Formal change control reporting systems
- Enhanced compliance monitoring
This strengthens regulatory traceability throughout the product lifecycle.
Standardized Inspection and Verification Procedures
Previous Framework
Inspection practices differed across regions and inspectors. Reporting formats were inconsistent, and follow-up timelines were not always clearly defined.
Updated Requirements
The revised regulation establishes unified inspection protocols that include:
- Standardized evaluation criteria
- Uniform inspection certificate formats
- Transparent reporting processes
- Defined corrective action timelines
- Risk-based inspection frequencies
These measures promote greater consistency and accountability in regulatory oversight.
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 signals a decisive move toward a more structured, internationally harmonized regulatory environment. While compliance requirements have become more detailed, regulatory outcomes are now more predictable.
For manufacturers, this shift emphasizes the importance of:
- Early regulatory planning
- Standardized technical documentation
- Integrated software governance
- Proactive pre-submission engagement
- Robust lifecycle management systems
Organizations that adapt early are better positioned to minimize delays and accelerate market access.
Preparing for Compliance Under Notice 2026-6
To navigate the revised framework effectively, manufacturers should consider:
- Conducting gap analyses against updated STED and SaMD requirements
- Revising internal documentation templates
- Strengthening change management processes
- Enhancing software validation and cybersecurity programs
- Engaging early with MFDS through formal pre-review channels
Strategic regulatory support can further streamline implementation.
Conclusion
MFDS Notice 2026-6 represents a major step forward in modernizing Korea’s medical device regulatory system. By strengthening international alignment, formalizing review procedures, and expanding oversight of digital technologies, MFDS has created a more transparent and predictable pathway to market.
Although compliance may require operational adjustments, the long-term benefits include reduced regulatory uncertainty, improved review efficiency, and stronger global integration.
For manufacturers willing to invest in early preparation and structured regulatory strategies, Notice 2026-6 offers an opportunity to strengthen both compliance and competitive positioning in the Korean market.
