Legal analysis: medical device license process: 1, the enterprise to the drug supervision department to submit the medical device license declaration materials. 2, the drug supervision department to review the materials. 3, the enterprise submitted materials formally accepted. 4, the relevant departments of the administrative review. 5, on-site review. 6, the relevant departments to make an administrative decision. 7, the preparation of certificates, licenses. Enterprises can choose to handle their own can also be entrusted to others to handle, Chengdu City and Zigong City, speech into can help to do, can provide the address, site layout, data preparation and submission
Legal basis: "Medical Device Registration Management Measures"
Article 1 In order to standardize the registration of medical devices and filing management, to ensure the safety and effectiveness of medical devices, according to the "Medical Devices Supervision and Administration Regulations,". The formulation of these measures.
Article 3 The registration of medical devices is based on the application of the applicant for registration of medical devices, in accordance with legal procedures, the food and drug supervision and management department of the medical device to be listed on the safety and efficacy of the research and its results of the systematic evaluation, in order to decide whether or not to agree to the process of its application. Medical device filing is the medical device filer to the food and drug administration to submit the record information, food and drug administration to submit the record information archived for inspection.