Medical Device and Healthcare Industry Trends — 2026-09-17
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The Ministry of Food and Safety (MFDS) is reshaping the regulatory landscape by strengthening institutional designation criteria following the implementation of the Digital Medical Products Act through revisions to medical device approval, notification, and review regulations. Meanwhile, the global MedTech regulatory relaxation trend is accelerating as the FDA launches the "TEMPO" pilot program to pave the way for generative AI medical devices to enter the market. Domestic companies are focusing on expanding the digital healthcare ecosystem, highlighted by Daewoong Pharmaceutical expanding its AI and medical device partnership network and GIVITA securing Series A investment.
Medical Device and Healthcare Industry Trends — 2026-09-17
Top 5 Headlines Today
- MFDS announces revisions to the "Regulation on Medical Device Approval, Notification, and Review" (Notice No. 2026-6) and notices related to the Digital Medical Products Act
- FDA launches the "TEMPO" pilot program, allowing patient access to generative AI medical devices prior to marketing authorization
- Daewoong Pharmaceutical builds a partnership network with over 60 domestic sales contracts and alliances spanning drugs, medical devices, and AI
- Digital healthcare startup GIVITA successfully secures 4.5 billion won in Series A funding
- FDA updates its list of approved digital healthcare (AI, AR/VR, sensor-based) medical devices
Daewoong Pharmaceutical
- What happened: Maximizing business synergy by building a tight partnership network covering various fields such as drugs, medical devices, and AI.
- Numbers: Over 60 domestic sales contracts
- Implications: Strengthening its position as a healthcare platform through a strategy that organically connects investment, distribution rights, and sales. This is interpreted as an intention to transform from a single-product-centric provider into an integrated solution provider.
GIVITA
- What happened: Secured Series A investment to develop and expand digital healthcare services for pre-diabetic patients.
- Numbers: 4.5 billion won in investment secured
- Implications: Plans to build an ecosystem connecting medical staff and patients through data by digitizing offline face-to-face medical protocols. This is a recognized case of the growth potential in the digital therapeutics (DTx) and chronic disease management markets.
MFDS, Policy, and Regulations (At least 3 items)
Revision of Medical Device Approval, Notification, and Review Regulations
- Details: Announcement of partial amendment to the "Regulation on Medical Device Approval, Notification, and Review" (Notice No. 2026-6)
- Target: Domestic medical device manufacturers and importers overall
- Implementation Timing: Within 2026 (notice number check required)
- Industry Impact: Expected to enhance predictability in licensing by increasing consistency with existing regulatory frameworks and clarifying the review process.
Revision of Regulations on Designation of Institutions Related to the Digital Medical Products Act
- Details: Announcement of partial amendment to the "Regulation on Designation of Institutions under the Digital Medical Products Act" (Notice No. 2026-5)
- Target: Digital medical product certification and evaluation agencies and related manufacturers
- Implementation Timing: Within 2026
- Industry Impact: Systematizes market entry barriers for Software as a Medical Device (SaMD) by detailing the institutional designation criteria and procedures required following the implementation of the Digital Medical Products Act.
Revision of Medical Device Item and Class Regulations
- Details: Announcement of partial amendment to the "Regulation on Medical Device Items and Item-specific Classes" (Notice No. 2026-18) and regulations related to in vitro diagnostic medical devices
- Target: In vitro diagnostic medical device manufacturers and importers, companies applying for new items
- Implementation Timing: March 9, 2026 (Note: One of recently announced amendment drafts)
- Industry Impact: Caution is required as licensing pathways (notification vs. approval) for certain products may change due to item classification and class modifications.
Digital Health & AI Medicine (At least 3 items)
- FDA TEMPO Pilot: Generative AI products such as Cadence and Limbic were selected for a regulatory sandbox-style pilot program allowing them to launch products to patients prior to marketing authorization.
- FDA Digital Health List Update: Updated the list of approved medical devices incorporating AI, AR/VR, and sensor-based technologies to reflect the latest digital health technology status.
- GIVITA Digital Protocol: Building a service model to digitize offline medical protocols for pre-diabetes management and connect medical staff and patients based on data.
Global MedTech Context
- FDA Generative AI Regulatory Innovation: The FDA allows pre-market entry of generative AI medical devices through the TEMPO pilot — Implications for the Korean industry: Domestic AI medical device companies need to review the "launch first, approve later" model and revise regulatory response strategies when expanding overseas.
- FDA Digital Health Approval Acceleration: Lists of approvals related to AI and wearables continue to be updated — Implications for the Korean industry: Securing FDA approval data is emerging as a core KPI to close the technology gap with global competitors such as Samsung and LG.
Investment, M&A, and IPO Trends
- GIVITA Series A: Secured 4.5 billion won to fund the expansion of digital healthcare services.
Today's Insight
The MFDS's announcement of follow-up notices related to the Digital Medical Products Act and the FDA's launch of the TEMPO pilot suggest that "regulatory innovation" is a core buzzword for the digital healthcare industry in both countries. In particular, the FDA's drastic measure to allow pre-approval market testing demands a strategic approach from Korean companies that goes beyond simply obtaining licensing to accelerate data verification speed in clinical settings.
Checkpoints This Week
- Whether specific application guidelines for MFDS Notices No. 2026-6 and No. 2026-5 are distributed
- Initial user data disclosure and safety reporting trends of companies participating in the FDA TEMPO pilot
- Follow-up investment rounds and M&A news in the digital healthcare sector
Reader Action Items
- Practitioners: Check the full text of the revised MFDS notices to inspect whether licensing pathways for company products have changed
- Investors: Analyze the impact of the FDA's AI/wearable regulatory relaxation trend on Korean company valuations
- Founders: Optimize clinical design by referencing FDA's "pre-market entry" cases when developing digital therapeutics and AI diagnostic devices
This content was collected, curated, and summarized entirely by AI — including how and what to gather. It may contain inaccuracies. Crew does not guarantee the accuracy of any information presented here. Always verify facts on your own before acting on them. Crew assumes no legal liability for any consequences arising from reliance on this content.
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