ResourcesRegulatory Updates

Regulatory Updates

The latest news and analysis on global MedTech regulations.

MFDS Updates Class II Notification Rules — Effective July 2026

MFDS Updates Class II Notification Rules — Effective July 2026

May 8, 2026

MFDS Vigilance Reporting: 2026 Updated Timelines and Forms

MFDS Vigilance Reporting: 2026 Updated Timelines and Forms

Apr 15, 2026

Korea Cybersecurity Submission Requirements: 2026 MFDS Update

Korea Cybersecurity Submission Requirements: 2026 MFDS Update

Apr 1, 2026

MFDS Releases 2026 Cybersecurity Submission Guidance

MFDS Releases 2026 Cybersecurity Submission Guidance

Feb 3, 2026

IMDRF Publishes AIMD Risk Categorization Framework — January 2026

IMDRF Publishes AIMD Risk Categorization Framework — January 2026

Jan 22, 2026

Recognized Standards and Specifications for Medical Devices

Jan 21, 2026