Understanding South Korea's Strategic Roadmap for Digital Medical Product Safety Management

South Korea is positioning itself as one of the most active regulatory environments for digital health technologies. Supporting this ambition, the country's latest digital health roadmap provides an early indication of the regulatory priorities that are expected to shape future market access, compliance, and product development.

Announced by the Ministry of Food and Drug Safety (MFDS) on January 14, 2026, the “First Comprehensive Plan for Digital Medical Product Safety Management” establishes a long-term regulatory strategy focused on patient safety, regulatory innovation, cybersecurity, lifecycle management, and international harmonization for digital medical products.

The roadmap builds upon Korea's Digital Medical Products Act, which established a dedicated legal framework for regulating digital medical products, including Software as a Medical Device (SaMD), digital therapeutics (DTx), AI-based medical devices, and other software-driven healthcare technologies. Rather than introducing new legal requirements the plan indicates how this framework is expected to evolve over the coming years through future guidance, implementation measures, and regulatory initiatives.

Continue reading to explore the key implications, or contact Cisema for tailored support with digital medical product registration and compliance in South Korea.

Why Digital Medical Products Are Receiving Increased Regulatory Attention in Korea

Digital medical products present regulatory challenges that differ from those associated with many traditional medical devices.

Unlike conventional hardware-based products, software can be updated after commercialization, connected to external systems, and increasingly incorporates AI into healthcare applications. These characteristics create new considerations around cybersecurity, product performance, software changes, and post-market oversight.

At the same time, digital health technologies are moving rapidly into routine clinical use. AI-assisted diagnostics, digital therapeutics, remote monitoring platforms, and connected care systems are no longer experimental — they are becoming embedded in everyday healthcare delivery.

In response, MFDS has outlined a dedicated roadmap for digital medical product regulation, reflecting the growing importance of cybersecurity, lifecycle oversight, and AI governance within healthcare regulation.

These evolving characteristics were among the key drivers behind Korea's enactment of the Digital Medical Products Act and the development of the First Comprehensive Plan for Digital Medical Product Safety Management.

The Vision Behind South Korea's Digital Medical Product Strategy

MFDS’s stated objective for the First Comprehensive Plan is to establish an innovative regulatory framework and a science-based safety management system that supports digital transformation while ensuring the safe, effective, and reliable use of digital medical products.

The strategy is built around several key goals:

• Strengthening patient safety
• Modernizing regulatory oversight
• Supporting innovation
• Expanding regulatory science capabilities
• Promoting international cooperation
• Enhancing global competitiveness

Pillar 1: Enhancing Safety Management for AI and Digital Medical Products

One of the roadmap's primary areas of focus is strengthening oversight of AI-based and software-driven medical products.

Tightening Review Criteria for AI-Based Products

MFDS plans to strengthen regulatory review criteria for AI-based and generative AI-based digital medical devices.

While detailed requirements have not yet been published, the initiative signals continued regulatory attention to how AI-driven technologies are assessed before entering the Korean market. Companies planning future submissions should closely monitor developments in this area, as evolving review approaches may influence expectations for clinical evidence, performance validation, and real-world evidence, and supporting documentation.

Expanding Guidance for Industry

MFDS also plans to publish review outcomes and expand guidance in areas such as:

• Clinical evaluation
• Product information requirements

These initiatives are expected to improve transparency and help manufacturers better understand MFDS expectations. However, future guidance will likely provide the practical detail that is not yet captured in the high-level roadmap.

Introducing Digital Product-Specific Post-Market Management

In recognition that software-based products require continuous oversight beyond approval, the roadmap introduces plans for post-market management measures tailored specifically to digital medical products.

For manufacturers, this initiative reinforces the importance of viewing compliance as an ongoing lifecycle activity rather than a process that ends once authorization has been obtained.

Pillar 2: Strengthening Cybersecurity for Digital Medical Products

Cybersecurity features prominently throughout the roadmap. As healthcare technologies become increasingly connected, cybersecurity is emerging as a critical component of digital medical product regulation — not only for data security but also product functionality and patient safety.

Establishing Cybersecurity Management Systems

MFDS plans to establish cybersecurity management systems for digital medical products, including approaches based on Software Bill of Materials (SBOM) frameworks.

SBOM (Software Bill of Materials) provides a structured inventory of software components used within a product and is increasingly recognized as an important tool for cybersecurity risk management.

While implementation details remain forthcoming, the inclusion of SBOM frameworks highlights MFDS's focus on software transparency and cybersecurity risk management.

Standardizing Incident Response Procedures

MFDS also plans to develop standardized procedures for responding to cybersecurity incidents and electronic threats.

Together with the proposed cybersecurity management systems, these initiatives suggest increasing emphasis on how cybersecurity risks are identified, monitored, and managed throughout the lifecycle of digital medical products.

For companies already navigating cybersecurity requirements in other jurisdictions, these developments may indicate growing alignment with broader international regulatory trends.

Pillar 3: Advancing Regulatory Innovation for Digital Health

Alongside its safety initiatives, MFDS is also focused on ensuring that regulatory systems continue to evolve alongside emerging technologies.

Building Regulatory Pathways for Emerging Technologies

Beyond product-level review requirements, MFDS also plans to establish regulatory frameworks specifically designed for AI-based medical devices.

Whereas review criteria determine how individual products are assessed, regulatory frameworks help define the broader rules and processes governing an entire technology category. This initiative reflects MFDS's intention to continue adapting its regulatory system as AI technologies evolve.

Supporting Industry Development

MFDS also plans to expand quality management certification programs, introduce performance certification programs, and support self-regulatory initiatives within the digital healthcare and wellness sectors.

Although the roadmap does not yet provide implementation details, these initiatives indicate MFDS's interest in using a broader range of regulatory tools beyond traditional product review and approval processes.

Developing Integrated Review Pathways for Digital Combination Products

MFDS also plans to develop integrated review pathways for digital combination products consisting of pharmaceuticals and digital medical devices including digital therapeutics used in combination with medicinal products.

This initiative may be particularly relevant for developers whose products combine pharmaceutical and digital components. As these technologies become increasingly integrated, coordinated review pathways could provide greater clarity regarding how such products are assessed within the Korean regulatory framework.

Pillar 4: Accelerating Industry Support and Global Expansion

While Pillar 3 focuses on regulatory frameworks and pathways, the roadmap also includes initiatives aimed at helping companies navigate those frameworks more effectively and strengthening South Korea's international regulatory engagement.

MFDS plans to:

• Introduce lifecycle-based regulatory support programs for AI medical devices
• Expand on-site regulatory consultation services
• Advance international regulatory cooperation and standardization initiatives
• Strengthen regulatory science expertise and industry communication programs

Together, these measures are intended to help companies navigate regulatory requirements more effectively while supporting greater alignment with global regulatory practices.

For international manufacturers, the emphasis on regulatory cooperation and standardization may be particularly noteworthy as they develop regional and global market access strategies.

Preparing for the Future of Digital Medical Product Compliance in South Korea

Although many aspects of the roadmap will be implemented over time, the direction of travel is already clear.

Companies evaluating the Korean market should assess whether their existing regulatory and compliance frameworks adequately address the roadmap's key focus areas: AI governance, cybersecurity, software lifecycle management, post-market oversight, and quality systems.

Focus on Capability Gaps

Organizations should use roadmap as an opportunity to evaluate their current state of readiness.

Key questions include:

• Are cybersecurity processes sufficient for connected and software-driven medical products?
• Can software updates and product modifications be managed through documented lifecycle and change management procedures?
• Do quality management systems adequately support software development, cybersecurity activities, and post-market obligations?
• Is the organization prepared to generate the evidence and documentation that may be required under evolving AI-specific review approaches?
• Can existing quality management systems adequately support continuous software updates, AI model changes, and cybersecurity risk management throughout the product lifecycle?

Identifying gaps early can help reduce compliance challenges as the regulatory framework continues to develop.

Monitor Regulatory Developments Closely

The roadmap establishes MFDS's strategic direction, but future guidance and implementation measures will determine how these priorities are translated into practical requirements.

Companies should therefore closely monitor developments in areas such as AI review criteria, cybersecurity management, software change management, and post-market obligations. As the framework evolves, partnering with an experienced local regulatory specialist, such as Cisema, can help interpret new guidance and compliance requirements.

Build Regulatory Strategy Beyond Initial Market Entry

One of the clearest messages from the roadmap is that MFDS is increasingly focused on the full lifecycle of digital medical products, not simply pre-market review. It’s therefore vital that software-based medical product manufacturers ensure their regulatory, quality, and compliance strategies extend beyond initial registration.

Organizations that begin strengthening these capabilities now will be better positioned to adapt as South Korea's digital medical product regulatory framework matures.

Final Thoughts

South Korea's First Comprehensive Plan for Digital Medical Product Safety Management provides an important glimpse into the future direction of digital health regulation in one of Asia's most technologically advanced healthcare markets.

While many implementation details remain to be developed, the roadmap clearly signals MFDS's priorities: stronger oversight of AI-enabled products, greater attention to cybersecurity and software lifecycle management, enhanced post-market controls, and increased support for innovation.

For companies evaluating market opportunities in Korea, these priorities offer valuable insight into where regulatory expectations are likely to develop next. Organizations that begin aligning their regulatory, quality, and compliance strategies with these emerging themes will be better positioned as the framework continues to mature.

For tailored, local support navigate South Korea’s evolving regulatory landscape for digital medical products, including regulatory affairs, quality management, compliance, and market access strategy, contact Cisema today.

Further Information

Explore Cisema’s services for medical device registration in South Korea.

About the Author: Will Noh

Will Noh brings more than 14 years of Regulatory Affairs and Quality Assurance experience across the medical device and healthcare industries, with deep expertise in South Korea’s Ministry of Food and Drug Safety (MFDS) regulatory framework. As Regulatory Affairs Manager at Cisema Korea, he supports international companies seeking market access in South Korea, providing regulatory, quality, and Local Authorized Representative (LAR) services for pharmaceuticals, medical devices, quasi-drugs, and cosmetics.

References

• Clinical Study Guidance for Digital Medical Devices (디지털의료기기 등의 임상시험 가이드라인)
• Digital Medical Products Act (디지털의료제품법)
• Enforcement Decree of the Digital Medical Products Act (디지털의료제품법 시행령)
• GMP Guidance for Digital Medical Devices (디지털의료기기 GMP)