Supervision and management of the use of medical devices quality

The State Food and Drug Administration to develop medical device production quality management standards and supervise the implementation. Food and drug supervision and management departments in accordance with the law and timely release of medical device production license and filing related information. Applicants can inquire about the progress of approval and approval results; the public can access the approval results. Medical device manufacturers shall be responsible for the quality of medical devices produced. Commissioned production, the commissioning party is responsible for the commissioned production of medical devices quality. Engaged in the production of medical devices, should have the following conditions: (a) with the production of medical devices and the production of appropriate production sites, environmental conditions, production equipment and professional and technical personnel; (b) the production of medical devices to carry out quality inspection of the organization or full-time inspectors and inspection equipment; (c) have to ensure that the quality of medical devices management system; (d) with the production of medical devices and the appropriate After-sales service capabilities; (E) in line with the product development, production process documentation requirements. Article I in order to strengthen the supervision and management of biological materials and medical devices, to ensure the safety and effectiveness of clinical use, and safeguard people's health, the development of these measures.

The second approach referred to in this biomaterials and medical devices refers to diagnostic and therapeutic interventions and implanted materials and equipment.

Biological materials and medical devices varieties of management by the Ministry of Health to develop and publish.

Article 3 of the State to encourage scientific research and advanced technology of biological materials and medical devices to promote, and give full play to its role in the prevention and treatment of disease and rehabilitation and health care.

Article 4 The Ministry of Health is responsible for formulating health standards for biological materials and medical devices, promulgating technical requirements; approving clinical research; approving biological materials and medical devices, and issuing approval numbers.

Provincial health administrative departments are responsible for clinical research on biological materials and medical devices and the approval of the initial examination of the number of health administrative departments at or above the county level to carry out health supervision of biological materials and medical devices in the area under their jurisdiction.

Article V of the new biological and medical devices for clinical research before the development unit must be located in the provincial health administrative department to apply. Provincial administrative departments of health after the initial review of the Ministry of Health, the Ministry of Health approved by the review of clinical research. The Ministry of Health to make a decision within three months after receiving all the materials.

How many years is a medical device license valid?

5 years, medical device business license is a medical device business enterprises must have the documents, the opening of the second class of medical device business enterprises, should be to the provinces, autonomous regions, municipalities directly under the Central People's Government Drug Administration for the record; the opening of the third class of medical device business enterprises, should be by the provinces, autonomous regions, municipalities directly under the Central People's Government Drug Administration for review and approval,

To summarize, the use of medical equipment quality supervision and management methods to answer the question, it is recommended that you strictly in accordance with the relevant provisions to implement, to avoid a series of problems.

Legal basis:

"Regulations for the Supervision and Administration of Medical Devices" Article 1 In order to ensure the safety and effectiveness of medical devices, to protect human health and life safety, and to promote the development of the medical device industry, the formulation of these regulations. Article 2 in the Chinese people *** and the country engaged in the development, production, operation, use of medical devices and their supervision and management activities, the application of these regulations. Article 3 the state council drug supervision and management department is responsible for the national supervision and management of medical devices. The relevant departments of the State Council in their respective areas of responsibility for supervision and management of medical devices.