EU Revises RoHS Annex II for phthalate limits: learn how the 100 ppm rule and DIBP inclusion affect EU exports, suppliers, testing, and compliance planning before Feb 2027.

FDA Tightens Importer Duties for Medical Devices: Learn how new U.S. Agent, UDI, batch, and serial data rules may affect import clearance, compliance readiness, and exporter risk.

FDA tightens entry rules for unregistered device makers. Learn how new FDA registration, U.S. Agent, and product listing checks may trigger detention and disrupt U.S.-bound medical device shipments.

FDA Tightens U.S. Entry Rules for Vietnam-Linked Devices: learn how VMDA preregistration and VMDA-ID requirements may affect medical device exports, OEM supply chains, and U.S. shipment clearance.

Vietnam VMDA pre-registration will become mandatory for imported medical equipment from August 2026. Learn the 30-day rule, required certificates, and how to avoid customs delays.

FDA Tightens Import Files for AI Medical Devices: learn how the 2026 FDA import documentation update affects clearance, compliance, and delivery planning for U.S.-bound AI medical equipment.

ANVISA tightens filing rules for AI beauty devices in Brazil. Learn the new registration requirements, local clinical report needs, and how exporters can protect market access.

EU updates RoHS Annex II with four nanomaterial restrictions, impacting EEE exports to Europe. Learn what changes by 2027 and how to prepare compliance, traceability, and supplier documentation now.