We strictly follow “Good Manufacturing Practice for Sterile Medical Devices” YY0033-2000. The quality assurance systems have been established and are effectively implemented in accordance with ISO13485:2003 “Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes” and ISO9001:2000 “Quality Management Systems – Requirements”. Our products are manufactured according to the standards of GB8368-2005, GB8369-2005 and GB15810-2001, and they prove to be qualified in random inspections by State Medical Devices Quality Supervision and Inspection Center.
Our manufacturing site has an area of 100 mu (66,700m2), with building area of 10,000 m2 in the first-stage project, including various warehouses of 2,500m2 and 100,000-Class medical purificating-room workshops of 3,600m2. There are independent sterilization workshops and laboratories, more than 60 sets of manufacturing equipments and 40 sets of testing equipments in the company. All the workshops are HVAC controlled with air distribution system at constant temperature of 18oC – 28oC all year round. Numbers of bacteria and particles are strictly controlled. The production capacity is 150 million pieces/sets of disposable sterile syringes, transfusion sets and infusion sets. The second-stage project will be mainly for producing medical beds, trolleys, bandages, swabs and infusion bottles for children. Our company is going to be the largest manufacturing base of medical devices in the central-western region in China after the completion of the second-stage project at the end of 2010.