Hong Kong MDACS 2025 Guidance for Medical Device Listing
The Department of Health’s latest guidance, GN-01:2025-1(E), tightens administrative controls for medical device listings in Hong Kong. Manufacturers must now adhere to stricter renewal windows, enhanced Local Responsible Person (LRP) duties, and mandatory tracking for high-risk implants to maintain market access. Hong Kong, January 5, 2026 – The Medical Device Division (MDD) has released the […]
INDIA CDSCO RELEASES 2026 RISK CLASSIFICATION LIST FOR ONCOLOGY DEVICES
New Delhi, January 5, 2026 — The Central Drugs Standard Control Organisation (CDSCO) has officially released its definitive Risk Classification List for Medical Devices Pertaining to Oncology. Dated January 2, 2026, this new guidance provides clarity for manufacturers and importers by categorizing 77 specific oncology devices into four risk classes under the Medical Devices Rules, […]