Each medical device manufacturing enterprise must h***e a medical device manufacturing enterprise license, which is supervised and issued by local SFDA. Enterprises who want to obtain the license must meet national medical device industry’s development plan and industrial policy. The SFDA should regulate the medical device enterprises. And the conditi*** for enterprises to obtain the license are as follows:
Ⅰ. People who are resp***ible for the production, quality and technology must h***e 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 h***e 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 h***e the quality inspecting ability that meets the production varieties and scale.
Ⅴ. Enterprises must keep related laws, regulati*** and standa*** about producing and managing medical device.
Ⅵ. If enterprises want to do the production of class Ⅲmedical device, In addition to possess all the conditi*** above , the following conditi*** 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.
O***unda is a service group which is engaged in medical device regulation c***ulting, medical device registered agent, medical device management system certification and product certification, focusing on providing medical device enterprises international medical device registration（CE、FDA、CMDCAS、TGA、JPAL、SFDA、PPE）、medical device system certification（ISO13485、YY/T 0287、GMP、QSR820、GSP）,doing second and third party audit for medical device suppliers, providing detail information of c***ulting the medical production manufacturing license.