Prost Pharma Group. was established in 2000 with a registered capital of 100 million RMB. It is a national high-tech enterprise integrating the research and development, production and sales of medicines, medical device and Medical beauty products, . The company has high-quality employees, a complete quality management system and first-class facilities, which can ensure continuous production of Class III medical devices that meet the requirements of the State Food and Drug Administration (SFDA) and the US State Food and Drug Administration (SFDA). And drug injection products. EU MDD.
Quality system
ISO9001 quality management system certification
ISO13485 medical device quality management system certification
Medical Device Directive (MDD93 / 42 / EEC)
In Vitro Diagnostic Equipment Directive (IVDD98/79/EC)
GB/T19001-2008
YY / T0287-2003
Good Manufacturing Practice for Drugs (GMP) (Revised in 2010)
Good manufacturing practices for in vitro diagnostic reagents
Good Manufacturing Practices for Medical Devices
In addition, on the basis of the above-mentioned quality management system, Prost Pharma Group has also established a document-based quality management system that uses quality objectives, audit results, data analysis, corrective and preventive measures, and management reviews to maintain strict quality control.