Medical Device Supervision and Administration Regulations Amendments (for review)
1, Article 34, paragraphs 1 and 2 combined into a paragraph, and add a paragraph as the second paragraph: "medical equipment should be used in accordance with the function of positioning, medical technology and other factors such as scientific configuration and rational use of suitable large medical equipment. The state to develop large medical equipment configuration planning, large medical equipment by item to implement a hierarchy of configuration licenses. Configuration of large medical equipment should be in line with the configuration plan, and with the appropriate technical conditions, the use of capacity, supporting facilities and the ability to have the appropriate qualifications of professional and technical personnel. Medical equipment using units configured large medical equipment, subject to the approval of the provincial people's government departments in charge of health planning and obtain a configuration license before configuration. Large medical equipment management items and configuration management by the State Council, the competent department of health and family planning in accordance with the Regulations formulated separately."
Second, Article 56, paragraphs 1 and 2 are combined into one paragraph, and add a paragraph as the second paragraph: "the competent department of health planning shall assess the use of large-scale medical equipment, standardize the use of behavior".
Third, 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 authorities to give a warning, ordered to stop using, confiscate the illegal income; illegal income of less than 10,000 yuan and impose a fine of 10,000 yuan or more than 50,000 yuan; illegal income of more than 10,000 yuan, and impose a fine of 5 times the illegal income of more than 10,000 yuan. And impose more than 5 times the illegal income of 10 times the following fine; the circumstances are serious, within five years will not accept the relevant responsible person and medical equipment use units to apply for large medical equipment configuration license."
Four, the first paragraph of Article 64 was amended to read: "provide false information or take other deceptive means to obtain a medical device registration certificate, medical device manufacturing license, medical device license, large-scale medical equipment configuration license, advertising approval documents and other licenses, by the original licensing department to revoke the licenses that have been obtained, and impose a 50,000 yuan Above 100,000 yuan fine, not to accept the relevant responsible persons and units within five years of the application for medical device license".
Fifth, the first paragraph of Article 68 is amended to guess the base boring: "one of the following circumstances, by the people's government at or above the county level, food and drug supervision and management department and the competent department of health planning and health department in accordance with their respective responsibilities and ordered to make corrections, and give a warning; refused to make corrections, impose a fine of 5,000 yuan or more than 20,000 yuan or less; if the circumstances are serious, ordered to stop production and stop using Until the original licensing department to revoke the medical device production license, medical device license and large medical equipment configuration license", and add a content as the ninth item: "medical device user units are not in accordance with the diagnosis and treatment specifications for the rational use of large medical equipment, can not guarantee the quality and safety of medical care ", the original ninth item adjusted to the tenth item.
Sixth, Article 73 was amended to read: "The food and drug administration and the competent authorities of health and family planning and front its staff should be strictly in accordance with the types and ranges of penalties provided for in these regulations, according to the nature of the violation and the specific circumstances of the exercise of the right to administrative penalties, the specific measures by the State Council food and drug supervision and management and the competent authorities of health based on the Their respective responsibilities to develop."
Seven, Article 76 to add a paragraph as the fourth paragraph: "large-scale medical equipment, refers to the use of complex technology, large amount of capital investment, high operating costs, high impact on medical costs, large-scale medical devices into the national management items."
VIII. This amendment shall come into force on the date of publication.