1. Establish and improve the organization of the enterprise according to the requirements of the National Bureau of medical device business enterprise on-site inspection and acceptance, and assist the enterprise to carry out medical device regulations and practical training. 2. Examine the existing hardware situation of the enterprise, and according to the requirements of the "national medical device business enterprise on-site inspection and acceptance standards" with the enterprise *** with the development of hardware rectification program, engineering design program. 3. Installation of software Management system, to assist enterprises to complete the preparation of quality management system documents. 4. Provide samples or templates of reporting information, to guide enterprises to complete the preparation of reporting information. 5. To the drug regulatory authorities to apply for a license inspection and follow up until the acquisition of the medical device business license certificate. 6. industrial and commercial business license. Different regions may have some details of the requirements for this area. The most certain way is to directly find the website of your provincial Drug Administration to find the relevant requirements.
The general process is: to confirm the need to operate the device category ----- according to the different categories, to determine whether the municipal or provincial bureau to apply for ---- to find the operating company required to submit the content of ---- according to the requirements of the preparation of information ---- to submit an application ---- review and approval.