CDSCO Issues New Directive on Manufacturing Licenses for Class A, B & IVD Medical Devices
23 October 2025, Central Drugs Standard Control Organization (CDSCO), India — In a significant move to tighten regulatory control, the Central Drugs Standard Control Organization (CDSCO) has issued a directive aimed at streamlining the grant of manufacturing licenses for Class A and Class B medical devices, as well as in-vitro diagnostic (IVD) devices under the […]
EDA Issues New Requirements for Procedure Packs Under EU MDR in Absence of Certificate of Free Sale
Cairo, Egypt 29 October 2025 —- The Egyptian Drug Authority (EDA) has issued a significant regulatory update concerning the import of Procedure Packs under the EU Medical Device Regulation (MDR) 2017/745. This announcement provides essential clarity for manufacturers and importers when a Certificate of Free Sale (CFS) is not available from a reference country for […]
EU Language Requirements for Medical Devices: A Guide to MDR & IVDR Compliance
YOUR EASY GUIDE TO MDR/IVDR LANGUAGE COMPLIANCE ACROSS EUROPE The EU requires that all medical devices (MDR) and in vitro diagnostic devices (IVDR) provide information such as labels, packaging text, and instructions for use in the correct language for the country where the device is sold. Each EU Member State decides which official language(s) must […]