1, understand the relevant laws and regulations: Understand the relevant laws and regulations of the medical device business site, including the "supervision and management of medical devices regulations", "medical device business enterprise management regulations" and so on. These regulations stipulate the basic requirements and standards for medical device business sites, as well as the relevant regulatory measures and penalty provisions.
2. Rectification of site non-compliance: According to the requirements of relevant laws and regulations, rectification of site non-compliance. Specific measures include adjusting the layout of the site, improve environmental health, strengthen equipment and facilities management. The rectification process should pay attention to ensure the safety, effectiveness and legality of medical devices.
3, to the relevant departments to declare: rectification is completed, should be submitted to the local health administrative department of the relevant declaration materials, apply for re-approval and approval of medical device business license. If the site illegal situation is more serious, but also need to accept the inspection and review of the relevant departments.
4, comply with laws and regulations: After the rectification is completed and approved by the relevant departments, it is necessary to strictly comply with the relevant laws and regulations, to keep the medical device business site in line with the norms and standards, to maintain the safety and efficacy of the medical devices, and to ensure that the public's life safety and health.