IVD Diagnostic Kits

IVD reagents evaluation starts with accuracy and lot stability. Learn how to verify performance, detect batch drift, and reduce diagnostic risk with practical review steps.

Saudi SFDA Adds RTase Origin Rule for PCR Kits: learn how the new October 2026 labeling and CoA requirement affects exporters, suppliers, and compliance teams entering Saudi Arabia.

Malaysia mandates digital readouts for POCT tests, reshaping compliance, customs clearance, and supply chains. Learn what exporters, distributors, and buyers must do now.

FDA Tightens CLIA Reagent Import Exemption Path: learn how the new USP <1208> Extractables report requirement may raise compliance costs, affect filings, and reshape delivery planning before Sept. 1, 2026.