Legal analysis: medical technology is divided into three categories:
The first category of medical technology refers to the safety and effectiveness of the exact, the medical institutions through routine management in the clinical application of the technology can ensure its safety and effectiveness.
The second category of medical technology refers to the safety and effectiveness of the exact, involving certain ethical issues or high risk, health administrative departments should be controlled and managed medical technology.
The third category of medical technology refers to one of the following circumstances, medical education network collects and organizes the need for health administrative departments to strictly control the management of medical technology:
(a) involves major ethical issues;
(b) high-risk;
(c) the safety and efficacy of the standardized clinical trial studies need to be further verified;
(d) the need to use rare and effective medical technology. p>(iv) requires the use of scarce resources;
(v) other medical technologies requiring special management as stipulated by the Ministry of Health.
Legal basis: "Medical Device Business License Management Measures"
Article 1 In order to strengthen the supervision and management of medical device business license, according to the "Regulations for the Supervision and Administration of Medical Devices", the formulation of these measures.
Second "medical device business license" issued, renewal, change and supervision and management of the application of these measures.
Article 3 The operation of the second and third class of medical devices should hold a "medical device business enterprise license", but in the circulation process through routine management can ensure its safety, effectiveness of a few second class of medical devices can not apply for "medical device business enterprise license". Do not need to apply for a "medical device business license" of the second class of medical devices by the State Food and Drug Administration to develop a product list.
Article IV of the State Food and Drug Administration in charge of the national "medical device business license" supervision and management. Provinces, autonomous regions, municipalities directly under the Central (food) Drug Administration is responsible for the jurisdiction of the "medical device business license" of the issuance, renewal, change and supervision and management. Municipal (food) drug supervision and management agencies or provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management departments set up directly by the county (food) drug supervision and management agencies are responsible for the jurisdiction of the "medical device business license" of the daily supervision and management work.