In January 2024, South Korea enacted the Digital Medical Products Act (DMPA)—a landmark piece of legislation designed to regulate the growing field of digital health technologies, including AI-driven devices, digital therapeutics, and health-related software. As the first comprehensive law focused solely on digital medical products, the DMPA represents a major step toward ensuring the safety, effectiveness, and innovation of digital healthcare solutions. Here’s an overview of what this law entails and its implications for the medical device industry.
Why Was the DMPA Introduced?
With the rapid rise of AI diagnostics, digital therapeutics (DTx), and health apps, Korea’s existing medical device regulations were insufficient to fully address these innovations. The DMPA was introduced to:
- Ensure patient safety and product effectiveness in a fast-evolving field
- Provide clear pathways for regulatory approval and oversight of digital health products
- Encourage innovation and promote Korea’s competitiveness in global digital health markets
What Does the DMPA Cover?
The Act defines "Digital Medical Products" broadly, encompassing three key categories:
- Digital Medical Devices (디지털의료기기): Devices using AI, robotics, or software for diagnosis, treatment, or monitoring (e.g., AI radiology tools, smart implants).
- Digital Combination Pharmaceuticals (디지털융합의약품): Drugs combined with digital components (e.g., a pill paired with a tracking app). These are regulated similarly to combination products.
- Digital Medical & Health Support Devices (디지털의료ㆍ건강지원기기): Wellness apps and tools that support health management (e.g., fitness trackers, diet monitoring apps).
By defining these categories, the DMPA creates a clear regulatory scope, covering both high-risk clinical tools and lower-risk health applications.
Key Regulatory Framework and Provisions
- Risk-Based Classification
The MFDS will classify digital medical products by their intended purpose and potential risk to users. Regulatory requirements are tiered accordingly. Higher-risk products (e.g. an AI diagnostic tool influencing critical treatment decisions) will undergo strict review, whereas lower-risk products (e.g. a wellness app) face simpler notification processes. This ensures a proportionate level of scrutiny and safety management for each product class. - Licensing and Premarket Approvals
Manufacturers and importers must obtain:- A business license from the Ministry of Food and Drug Safety (MFDS).
- Product-specific approval based on risk classification before market entry.
- Software Quality and Cybersecurity Requirements
Given the nature of digital products, the DMPA emphasizes:- Software quality management: Manufacturers must follow MFDS standards to ensure software safety. While optional, Conformity Certificates, valid for three years, to prove compliance with quality requirements.
- Cybersecurity measures: Mandatory protection against hacking, viruses, and other malware, manufacturers must ensure continuous updates and monitoring to address security risks.
- Post-Market Surveillance
Manufacturers must monitor product performance post-market, identify and manage safety issues, and address emerging risks, including cybersecurity vulnerabilities. MFDS may require periodic post-market safety and efficacy reports. - Optional Performance Certification for Health Support Devices
For low-risk products, companies may opt for MFDS performance certification, offering a quality seal that can improve market acceptance. - Regulatory Flexibility for AI and Software Updates
Recognizing that AI-based products evolve, the DMPA allows pre-approved change management plans, enabling companies to update algorithms without requiring full re-approval, as long as updates remain within pre-approved parameters. Significant changes that could impact patient safety still require additional regulatory review. - Real-World Evidence (RWE) Integration
The DMPA notably encourages the use of Real-World Evidence (RWE), leveraging data from routine clinical practices and patient usage post-market. This evidence supports ongoing assessments of digital medical products, potentially streamlining regulatory processes and facilitating faster iterations and improvements based on actual patient outcomes. Companies can utilize RWE to demonstrate long-term safety, efficacy, and value in real-life settings, enhancing credibility and market acceptance. - Enforcement and Recalls
MFDS holds the authority to enforce corrective measures, including recalls, suspensions, and disposal of non-compliant or hazardous products. It also conducts market surveillance and may require manufacturers to submit safety data to verify ongoing compliance.
How Digital Health Manufacturers Should Prepare for the DMPA
- Clearer Regulatory Pathways
Before the DMPA, many digital health products (especially software and AI) lacked a well-defined regulatory process. Now, developers of digital therapeutics, AI diagnostics, and health apps have a structured approval process, reducing uncertainty and facilitating faster market access. - Increased Compliance Obligations
Companies—especially startups and software-focused firms—will need to invest in:- Quality management systems tailored for digital products.
- Robust cybersecurity infrastructure and incident response plans to address regulatory concerns.
- Regulatory affairs expertise to manage MFDS submissions and compliance documentation.
Smaller companies may need to collaborate with regulatory consultants to meet these new demands.
- Boost to Innovation and Market Confidence
By establishing clear and robust standards, the DMPA enhances regulatory clarity and product reliability, leading to greater trust among clinicians and patients. Companies that comply may find smoother acceptance in international markets, leveraging DMPA compliance as a mark of quality. - Competitive Advantage for Early Compliers
Manufacturers who adapt early will gain first-mover advantage in Korea’s digital health sector, benefiting from new opportunities such as digitally enhanced pharmaceuticals and AI-assisted healthcare tools. Early compliance may also facilitate faster regulatory approvals and market entry. - Growth of New Product Segments
The DMPA encourages growth in areas like:- Digital therapeutics (DTx) (e.g., mental health apps paired with medication).
- AI diagnostics integrated into healthcare workflows.
- Certified wellness apps that go beyond simple tracking to clinically relevant interventions.
How Does DMPA Compare Internationally?
Korea’s DMPA is unique in being a standalone digital health law, unlike the U.S. and EU, which regulate digital health under broader medical device frameworks. However, it aligns with global trends emphasizing:
- AI and software-specific regulations.
- Mandatory Cybersecurity Standards for medical software.
- Risk-based oversight and full lifecycle management.
By segmenting digital health products into devices, combination products, and support tools, Korea has created a model that may inspire other regulators. Its emphasis on pre-approved AI software updates is particularly forward-thinking, potentially shaping future global regulatory approaches.
The Future of Digital Health in Korea: Implications of the DMPA
The Digital Medical Products Act (DMPA) marks a significant milestone in regulating digital health innovations in Korea. While it introduces stricter compliance requirements, it provides much-needed regulatory clarity and support for a sector poised for growth. For companies in the digital health space, early adaptation to DMPA standards can provide a competitive edge and unlock opportunities in both Korean and global markets.
With the Enforcement Rules now in effect, industry players should proactively assess their product portfolios, ensure alignment with MFDS guidelines, and prepare for a new era of digital health regulation in South Korea.
Ensure Compliance & Unlock Market Potential
The Digital Medical Products Act introduces new regulatory challenges, but also immense opportunities for innovation in South Korea’s growing digital health sector. Whether you're a local startup or a global manufacturer, staying ahead of compliance is key to market success.
With 25 years of expertise, Qualtech Consulting Corporation has been a trusted partner for medical device manufacturers, helping them navigate complex regulatory landscapes with ease.
Let us empower your digital medical products to enhance lives. Connect with us today to ensure seamless compliance and maximize your market potential!