Each medical device manufacturing enterprise must have 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. Osmunda is a service group which is engaged in medical device regulation consulting, 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 consulting the medical production manufacturing license.
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