Science & Tech · Cybersecurity · 3 hrs ago
South Korea revises medical device cybersecurity review guidance
South Korea’s National Institute of Food and Drug Safety Evaluation revised its medical device cybersecurity guidance on October 30.
The guidance covers how medical devices are assessed for approval and review.
The revised rules apply international standards to account credentials and password strength.
They also include changes based on issues that often lead reviewers to ask for additional information in South Korea.
The changes are intended to improve the country’s cybersecurity review process for medical devices.
The guidance has been revised, but no further steps or implementation timetable were given.
South Korea’s National Institute of Food and Drug Safety Evaluation revised its medical device cybersecurity approval and review guidance on October 30.
The changes apply international standards to requirements for managing authentication information and setting password strength.
The revision also incorporates cases that frequently require supplementary information during domestic reviews.
The institute said the changes aim to advance the approval and review system for medical device cybersecurity.
- Who
- South Korea’s National Institute of Food and Drug Safety Evaluation.
- What
- It revised guidance for medical device cybersecurity approval and review.
- When
- October 30, 2026.
- Where
- South Korea.
- Why
- To advance the medical device cybersecurity approval and review system.
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- Revised
- Medical device cybersecurity approval and review guidance
- Date
- October 30, 2026
- Authentication information
- Requirements now apply international standards
- Password strength
- Requirements now apply international standards
- Domestic reviews
- Frequently raised requests for supplementary information were incorporated