Health · Healthcare & Policy · 2 hrs ago
South Korea holds briefing on digital medical device approvals
South Korea’s safety evaluation agency held a briefing on digital medical devices on Oct.
28.
The event took place at the SETEC exhibition centre in Seoul’s Gangnam district.
It was aimed at people working in the medical device industry.
The agency explained new approval and review arrangements, including an innovation plan for emerging digital medical technologies.
It also covered 13 recently issued or revised guidelines for digital medical devices.
The briefing matters because these rules and guidelines set out how such products are assessed for approval.
The agency shared the information with industry participants; no further steps were announced.
South Korea’s National Institute of Food and Drug Safety Evaluation held a briefing on digital medical device approvals and reviews on Oct. 28.
The event took place at SETEC in Gangnam-gu, Seoul.
The institute presented an innovation plan for approving and reviewing emerging digital medical technologies.
It also shared information on 13 recently established or revised digital medical device guidelines.
The briefing was intended to inform industry participants about the new system and updated review standards.
- Who
- South Korea’s National Institute of Food and Drug Safety Evaluation held the briefing for industry participants.
- What
- A briefing on digital medical device approval and review systems and standards.
- When
- Oct. 28; the article was published in 2026.
- Where
- SETEC in Gangnam-gu, Seoul.
- Why
- To inform industry participants about new approval and review arrangements and updated guidelines.
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- Organizer
- National Institute of Food and Drug Safety Evaluation
- Date
- Oct. 28, 2026
- Venue
- SETEC, Gangnam-gu, Seoul
- Guidelines
- 13 recently established or revised digital medical device guidelines