Current situations of sterile and implantable medical device manufacturing in Sichuan Province:an investigation in 31 production enterprises / 中国组织工程研究

ABSTRACT

BACKGROUND:The Specification of Quality Management for Medical Device Production (for Trial Implementation) issued by the China Food and Drug Administration (CFDA) on December 16, 2009 was demanded to be initially implemented in medical device manufacturers with a higher risk in sterility and implant before January 1, 2011. The revised version was published on December 29, 2014 and came into effect on March 1, 2015. OBJECTIVE:To put forward specific suggestions through analyzing the status of 31 sterile implantable medical device manufacturers in Sichuan Province and the corresponding implementation situation of the specification for trial implementation. METHODS:The relevant data of these 31 manufacturers were collected through the quality management system assessment, supervision and inspection, flight inspection and questionnaire survey. And the data were analyzed statistically. RESULTS AND CONCLUSION:The overall size of medical device manufacturers in Sichuan Province is small. There are still some other problems, such as no advanced equipment, low quality of employees, lack of funds and inappropriate management, in these manufacturers. Considering these, we have given some guiding recommendations from the aspects of production and supervision.