It is reported that , in order to regulate the medical device production license management , Gansu Province has promulgated new regulations in the recently issued " Gansu Province Medical Device Manufacturing License and Registration Regulations ( Trial ) " in the provisions in licensing and production of medical devices record further refinement, the medical device manufacturers have also been clear regulation , introduced purpose of this provision is to further standardize the production license and product registration management .
Requirements spelled out in Gansu Province Food and Drug Administration is responsible for the approval of medical devices , the Food and Drug Administration is responsible for the province province product registration, production license supervision of the province are mainly responsible for Yixie test the quality of the province Yixie technical supervision, is also responsible for the province to register Yixie registered product testing, responsible for product standards compliance test. The province's Food and Drug Administration is responsible for the assessment Yixie Quality Certification Center standardize inspection , licensing and technical assessment Yixie production , there is some product registration technology assessment. The province 's Medical Device Safety Center is responsible for monitoring and evaluation of adverse events in the province Yixie monitoring and evaluation .
Also in the province provides a clear and Drug Administration of the City 's departments responsible for the area of medical device manufacturers to conduct daily supervision , but also responsible for the quality of production enterprises Yixie the supervision and implementation of standardized management , and also assume the first category of administrative examination and approval work Yixie products . Provisions clearly medical equipment production license is valid for five years, also required to perform a specified class of medical equipment manufacturing enterprises to obtain the "Gansu Province, the first class of medical device manufacturers record card " while engaged II and III medical equipment manufacturing enterprises to obtain Yixie manufacturing enterprise license , permit and registration tables are valid for five years.
In addition, the regulations also explicitly prohibit medical equipment production sites in the residential district, was not allowed to set up in business premises and hotels do not meet the environmental requirements of these places , not in the military administration of the restricted areas , if the period of validity there are three promises of the production license will be revoked.