"Medical device clinical trial organizations to implement record management. Medical device clinical trial organizations should have the conditions and filing 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."
Two, the first paragraph of Article 34, paragraph 2, as a combination of paragraph 1: "Medical devices should have the use of units with the use of medical equipment varieties, the number of storage places and conditions appropriate to the use of medical devices. 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 department in charge of health planning and obtaining a 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. The catalog of large medical equipment shall be proposed by the competent department of health planning and life planning under the State Council in consultation with the relevant departments of the State Council, and shall be 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 medical device production and management enterprises and the use of medical devices produced, operated and used in the sampling and inspection of medical devices. 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 and family planning shall supervise and evaluate the use of large-scale medical equipment; and shall immediately correct and deal with according to law, if it finds irregular use and excessive examination and treatment related to large-scale medical equipment."
Four, 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 government, 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; illegal income of more than 10,000 yuan, and impose a fine of 5 times the illegal income of 10 times the illegal income of 10 times the illegal income of 10,000 yuan. And impose a fine of not less than 5 times but not more than 10 times the amount of illegal income; if the circumstances are serious, the application for a license to configure large-scale medical equipment made by the relevant responsible person and unit shall not be accepted within 5 years."
V. The first paragraph of Article 64 shall be amended as follows: "Where false information is provided or other deceptive means are used to obtain a medical device registration certificate, a medical device manufacturing license, a medical device business license, a large-scale medical equipment configuration license, an advertisement approval document and other licenses, the original licensing department shall revoke the licenses that have been obtained and impose a fine of 50,000 yuan or more than 100,000 yuan and a fine of not more than 10,000 yuan within 5 years. Above 100,000 yuan fine, not to accept the relevant responsible persons and units within five years of the medical device license application."
Sixth, Article 66 to add a paragraph as the second paragraph: "medical device business enterprises, the use of units to fulfill the provisions of these 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 truthfully explain the source of its purchase, may be exempted from punishment, but shall be confiscated in accordance with the law. However, it shall be confiscated in accordance with the law of its operation, use of medical devices that do not meet the statutory requirements."
Seven, Article 68 to add an item, as the ninth: "(I) 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 will be changed from the original ninth to the tenth.
Eighth, 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 make corrections or immediately stop the clinical trial, and may impose a fine of less than 50,000 yuan; causing serious consequences, according to law, the directly responsible for the person in charge of the person in charge and other personnel directly responsible for a demotion, dismissal or dismissal of sanctions; the organization shall not carry out the relevant professional medical device clinical trials 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 the removal or dismissal of the sanction; the organization shall not carry out the relevant professional medical device clinical trial for 10 years. carry out relevant specialized medical device clinical trials."
9, Article 73 is amended to read: "The food and drug administration department, the competent department of health and family planning and its staff shall, in strict accordance with the types and ranges of penalties provided for in these Regulations, exercise the right to administrative penalties in accordance with the nature of the violation and the specific circumstances of the specific measures to be formulated by the State Council's food and drug administration department, the competent department of health and family planning in accordance with their respective responsibilities. responsibilities."
Ten, Article 76 added: "Large medical equipment, refers to the use of complex technology, large amount of capital investment, high operating costs, high impact on medical costs and large medical devices into the catalog management."