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“IMPORTANCE OF MATERIAL AND CHEMICAL CHARACTERISATION IN TOXICOLOGY RISK ASSESSMENT OF MEDICAL DEVICE”
Introduction The new Medical Devices Regulation (2017/745/ EU) (MDR) and the In Vitro Diagnostic Medical Devices Regulation (2017/746/EU) (IVDR) bring
The long-awaited roll out of the enhanced drug Marketing Authorization Holder (MAH) program in China
As a part of the drug evaluation and approval reform in China, the enhanced Marketing Authorization Holder (MAH) system is
FMD KL Quality Quiz @ Manila, Bangalore & Hyderabad
FMD K&L’s commitment to delivering high Quality services was demonstrated yet again through the recently concluded Quality related Quiz program
New Accelerated Regulatory Paths in China
At the end of August, China’s legislature finally approved the long-awaited Drug Administration Law. Capping the dizzying regulatory reform since