FDA CYBERSECURITY GUIDANCE TIGHTENS THE NET : NEW 2026 CYBERSECURITY RULES FOR MEDTECH
WASHINGTON, D.C., 10 Feb 2026 — The FDA has officially issued the final version of its high-impact FDA cybersecurity guidance, “Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions”. This document represents the Agency’s latest thinking on ensuring that medical devices remain resilient against the backdrop of increasing cyber threats and […]
HONG KONG MEDICAL DEVICE REGULATION ELEVATES MEDICAL TECH STANDARDS: NEW 2026 RULES FOR AI AND CYBERSECURITY
Hong Kong, 3 February 2026 – The Department of Health’s Medical Device Division (MDD) has officially updated two critical Technical References under the Medical Device Administrative Control System (MDACS). These documents, TR-007 (Software Medical Devices and Cybersecurity) and TR-008 (Artificial Intelligence Medical Devices), have been revised to address the rapid advancement of digital health technologies […]
USFDA REGULATIONS UPDATES COMPLIANCE PROGRAM CP 7382.850 FOR MEDICAL DEVICE INSPECTIONS
United States, 10 Feb 2026 — In line with USFDA regulations, the U.S. Food and Drug Administration (FDA) has officially issued a major update to its Compliance Program, CP 7382.850, titled “Inspection of Medical Device Manufacturers.” This update, which carries an implementation date of February 2, 2026, fundamentally shifts how the Agency will conduct inspections […]