FDA Tightens BSL-3/4 Import Rules for Bio-Barrier Systems: learn how digital twin verification and ISO 27001 decontamination logging could reshape compliance, costs, and delivery plans.

EN 17068:2026 makes RBV mandatory for BSL-3/4 decon systems, reshaping compliance, certification, and market access. See what importers, suppliers, and buyers must prepare before Feb 2027.

FDA Tightens Import Rules for BSL-3/4 Decon Systems: learn how new IIoT sensor and real-time data reporting requirements may impact exporters, OEM/ODM suppliers, distributors, and U.S. compliance planning.

FDA makes Digital Twin validation mandatory for BSL-3/4 imports starting Oct 1, 2026. Learn how the rule impacts biosafety equipment exports, compliance documents, and delivery timelines.

EU Tightens EN 13772 for BSL-3/4 imports: learn how the 2026 rule impacts certification, customs clearance, and EU market access for biosafety infrastructure exporters.

FDA Tightens Import Rules for BSL-3/4 Lab Systems: learn how new Digital Twin verification and IIoT monitoring requirements may impact U.S. market access, delivery timelines, and supplier readiness.

MFDS Tightens Decon System Validation Records: learn how South Korea’s new cloud and blockchain validation rules for imported Decon Systems may affect compliance, suppliers, and market access.

FDA updates remote validation rules for decon systems, allowing real-time IIoT cloud validation under 21 CFR Part 11. See what suppliers and regulated facilities must do now.