The content is as follows:
1, Definition and Classification: Medical devices are instruments, equipment, appliances, materials and other similar products used for the prevention, diagnosis, treatment, monitoring and mitigation of diseases, which are classified into three categories according to their risk levels.
2, production and sales license: the production and sale of medical devices must obtain the appropriate license, respectively, issued by the State Drug Administration and the provincial Food and Drug Administration.
3, the listing of the record and approval: the listing of medical devices must go through the appropriate record and approval procedures, including technical evaluation, clinical trials and so on.
4, product identification and instructions: medical devices must be labeled with the product name, specifications, batch number, date of manufacture, expiration date, manufacturer and other information, and accompanied by instructions for use.
5. Supervision, Inspection and Punishment: The supervisory and management departments will supervise and inspect the production, circulation and use of medical devices, and will give appropriate punishment for illegal behavior.
Agent in addition to the registration or filing of medical devices should also be responsible for:
1, and the corresponding food and drug supervision and management departments, overseas applicants or filers of the liaison;
2, to the applicant or the filer of the truthful and accurate conveyance of the relevant laws and regulations and technical requirements;
3, the collection of post-market medical device adverse event information and Feedback overseas registrant or filer, and at the same time report to the appropriate food and drug supervision and management departments;
4, coordination of medical devices after the listing of the product recall, and report to the appropriate food and drug supervision and management departments;
5, other product quality and after-sales service related to the joint responsibility.
In summary, through the supervision and management of medical devices can effectively protect public health and safety, and promote the healthy development of the medical device industry.
Legal basis:
Article 3 of the Regulations of the People's Republic of China on the Supervision and Administration of Medical Devices
Medical device registration is a systematic evaluation by the Food and Drug Administration of the applicant for the registration of a medical device according to the application of the applicant for the registration of a medical device, in accordance with the statutory procedures, on the safety and efficacy studies of the medical device to be listed on the market and the results of the system, in order to decide whether or not to agree with the application of its The process.
Medical device filing is the medical device filer to the food and drug administration to submit the record information, the food and drug administration of the filing information submitted to the archives for inspection.