Ⅰ. People who are responsible for the production, quality and technology must have the professional ability of producing medical devices and fully understand the law and regulation of medical device supervision and relevant products' quality and technology. Workers can not be in charge both of quality and production.
Ⅱ. The proportion of technicians who is primary or junior or above must meet the requirement of production.
Ⅲ. Enterprises must provide production facilities that meet the products and scale of production, place, storage and environment. Enterprises who have some special requirement for the facility and environment of production must meet the industrial and national standard.
Ⅳ. Enterprises should set up quality inspection body and have the quality inspecting ability that meets the production varieties and scale.
Ⅴ. Enterprises must keep related laws, regulations and standards about producing and managing medical device.
Ⅵ. If enterprises want to do the production of class Ⅲ medical device, In addition to possess all the conditions above , the following conditions are needed:
1. Internal auditors who qualified for the quality management system must not less than two.
2. Full time technical staff who is junior or college degree or above for related major must not less than two.
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