Contents are 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 penalties: the supervision and management department will supervise and inspect the production, circulation and use of medical devices, and will impose appropriate penalties for violations.
To apply for a medical device license, the specific operation method is:
1, specific understanding of the processing requirements: according to the relevant state laws and regulations and provisions, to understand the requirements and process of medical device license. You can check the relevant information through the official website of the National Health and Health Commission or the official website of the local health and health commission.
2, submit the application materials: the applicant needs to submit the application materials to the local health commission, including the copy of the business license of the enterprise legal person, the authorization letter of the medical device agent, the quality management standard documents of the medical device business.
3, review and acceptance: the local health commission to review the application materials, the applicant meets the requirements of the on-site acceptance, in order to confirm that its business premises meet the requirements, and the assessment of business personnel.
4, receive the license: after acceptance, the applicant needs to pay the relevant fees and receive the medical device business license.
In summary, the supervision and management of medical devices is a regulation issued by the State Food and Drug Administration.
Legal basis:
"Regulations of the People's Republic of China on the Supervision and Administration of Medical Devices"
Article 3
Medical device registration is the process by which the Food and Drug Administration, based on the application of an applicant for registration of a medical device and in accordance with the statutory procedures, systematically evaluates the safety and efficacy studies of the medical device that is to be listed on the market and the results of the study in order to determine whether or not to agree with the application. Whether to agree with the application process.
Medical device filing is a 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.