NEW IMPLEMENTING DECISION (EU) 2026/193 STANDARDS PUBLISHED
Europe, January 31, 2026 — The European Commission formally published Implementing Decision (EU) 2026/193 in the Official Journal of the European Union (OJEU). This decision updates the list of harmonised standards drafted in support of the Medical Device Regulation (EU) 2017/745 (MDR). It replaces older references with new 2024 and 2025 versions, covering critical areas […]
MALAYSIA’S DESIGNATED MEDICAL DEVICE ORDER 2026 PUBLISHED IN THE FEDERAL GOVERNMENT GAZETTE
Malaysia, 31 Jan 2026 — The Medical Device (Designated Medical Device) Order 2026 has now formally been published in the Federal Government Gazette. This new Order explicitly designates specific aesthetic equipment including various lasers, HIFU, and liposuction devices as regulated medical devices under the Medical Device Act 2012. For manufacturers of aesthetic equipment, this regulation […]