"Medical device clinical trial organizations to implement record management. Medical device clinical trial organization should have the conditions and record management and clinical trial quality management standard, by the state council food and drug supervision and management department in conjunction with the state council department in charge of health and family planning to develop and publish." Second, the first and second paragraphs of Article 34 shall be merged as the first paragraph: "Medical device use units shall have storage places and conditions that are compatible with the varieties and quantities of medical devices in use. Medical device use units should strengthen the technical training of staff, in accordance with product instructions, technical specifications and other requirements for the use of medical devices."
Add a paragraph, as the second paragraph: "medical equipment using units configured with large medical equipment, should be consistent with the State Council competent department of health planning and development of large-scale medical equipment configuration planning, and its functional positioning, clinical service needs are compatible with the corresponding technical conditions, supporting facilities and have the appropriate qualifications, capabilities, professional and technical personnel, and approved by the provincial level Above the people's government health planning department approval, obtain large medical equipment configuration license."
Add a paragraph as the third paragraph: "large-scale medical equipment configuration management by the State Council department in charge of health planning, in conjunction with the relevant departments of the State Council to develop. Catalog of large medical equipment by the State Council department in charge of health planning and health department of the State Council, proposed by the relevant departments of the State Council, reported to the State Council for approval and implementation." Third, the first and second paragraphs of Article 56 shall be merged as the first paragraph: "The food and drug supervision and management department shall strengthen the sampling and inspection of medical devices produced, operated and used by medical device manufacturing and operating enterprises and use units. Sampling and testing shall not charge inspection fees and any other costs, the required costs into the budget of the government at this level. Food and drug supervision and management department of the people's government at or above the provincial level shall, based on the findings of the sampling and testing of medical devices issued in a timely manner quality bulletin."
Add a paragraph as the second paragraph: "The competent department of health planning shall supervise and evaluate the use of large-scale medical equipment; found that the use of non-compliance as well as large-scale medical equipment related to excessive examination, excessive treatment and other circumstances, shall be immediately corrected, and dealt with according to law." Fourth, Article 63 to add a paragraph as the third paragraph: "unauthorized configuration and use of large-scale medical equipment, by the people's governments at or above the county level, the competent departments of health and family planning ordered to stop the use of the people's governments at or above the county level, give a warning, confiscate the illegal income; illegal income of less than 10,000 yuan and impose a fine of 10,000 yuan to 50,000 yuan or less; illegal income of 10,000 yuan or more and impose an illegal income of five times Above 10 times the following fine; the circumstances are serious, within five years will not accept the relevant responsible person and the unit of large-scale medical equipment configuration license application." The first paragraph of Article 64 is amended as follows: "Where false information is provided or other deceptive means are used to obtain a medical device registration certificate, medical device manufacturing license, medical device business license, large-scale medical equipment configuration license, advertising approval documents and other licenses, the original licensing department shall revoke the licenses that have been obtained and impose a fine of not less than 50,000 yuan and not more than 100,000 yuan within 5 years. Fines, not to accept the relevant responsible person and unit within five years of the medical device license application." Sixty-sixth Article to add a paragraph as the second paragraph: "Medical device business enterprises, the use of units to fulfill the provisions of the Regulations such as purchase inspection obligations, there is sufficient evidence to prove that it does not know that the operation, use of medical devices for the first paragraph of the previous paragraph, the third paragraph of the circumstances of the medical device, and can be truthfully accounted for the source of its purchase, may be exempted from punishment, but shall be confiscated according to law Its operation, use of medical devices that do not meet the statutory requirements." Seventh, Article 68 to add an item as the ninth: "(9) medical device use units in violation of the use of large-scale medical equipment, can not guarantee the quality and safety of medical care," and the original ninth item to the tenth. Eight, Article 69 is amended to read: "violation of the provisions of this regulation to carry out clinical trials of medical devices, by the people's government at or above the county level food and drug supervision and management department ordered to correct or immediately stop the clinical trial, and may impose a fine of less than 50,000 yuan; causing serious consequences, according to law, to the directly responsible officer in charge and other personnel directly responsible for the demotion, dismissal, or dismissal Sanctions; the organization shall not carry out clinical trials of related professional medical devices within five years.
"Medical device clinical trial organization issued a false report, by the people's government at or above the county level food and drug supervision and management department shall impose a fine of 50,000 yuan or more than 100,000 yuan; there is illegal income, the confiscation of the illegal income; directly responsible for the supervisor and other personnel directly responsible for the law shall be given to dismissal or dismissal of the sanctions; the organization shall not carry out the relevant professional medical device clinical trial for 10 years. carry out relevant specialized medical device clinical trials." IX. Article 73 is amended to read: "The food and drug administration department, the competent department of health and family planning and its staff shall exercise the right of administrative punishment in strict accordance with the types and ranges of penalties stipulated in these Regulations, according to the nature of the violation and the specific circumstances, and the specific measures shall be formulated by the food and drug administration department and the competent department of health and family planning under the State Council in accordance with their respective responsibilities. "