Oral Care Systems

PMDA Tightens Import Review for Home-Use HIFU Devices: learn how Japan’s new 3D thermal injury simulation requirement may affect import approvals, timelines, and compliance planning before September 2026.

EU customs tighten checks on sapphire-cooled IPL devices, putting CE-MDR Class IIa Clinical Evaluation Summary compliance at the center of clearance. Learn the risks, delays, and what exporters must verify now.

FDA Sets UV Safety Test Rule for Whitening Kits: learn how ISO 15004-2:2026 testing and UVA dose labeling will affect registration, customs compliance, and export timelines.