Medical network - July 3 on June 30, according to the jiangsu suqian health development planning commission website message, because of the large medical equipment examination and approval has been changed from non-executive licensing examination and approval matters for the administrative licensing items, according to the provincial planning commission of unified requirements, since June 22, 2017, suqian all kinds of medical institutions shall stop the purchase of large medical equipment, all purchase are considered to be illegal to purchase without approval.
First of all, the "call to stop" initiative is the uniform demand of jiangsu province, not just a city. Second, all kinds of medical institutions are "suspended" and private hospitals should be included. This movement is not small.
In addition, the news on the website of the city's health and family planning commission was not clear when the "stop" measures would end. Perhaps, it will continue until the transitional end of the configuration management model for large medical devices ends.
The large equipment configuration license is handled, the national health and family planning commission also called to stop
In fact, it is not just jiangsu province that is "stopping" big medical devices because of the reform of the state council's administrative review and approval.
In January this year, the national health development planning commission approval of Shanxi Province health development planning commission on the relevant issues of radiological diagnosis and license issuing instruct ", once said, large medical equipment allocation permission changed from non-executive licensing for the administrative licensing, the national health development planning commission is to perform the new set a new license application, in accordance with the state department to check and revise relevant requirements, in the meantime, license suspended for large medical equipment configuration.
The spirit of the above-mentioned document of the national health and family planning commission is applicable to all provinces.
However, in the case of the national health and family planning commission, the regulations on the supervision and administration of medical devices have not yet been revised.
On May 4 this year, the state council issued the 680 order, announcing the decision of the state council to amend the regulations on the supervision and regulation of medical devices (>), which will go into effect on the day of its promulgation.
The revised regulations on the supervision and administration of medical devices has added a few items, including: the configuration of large medical equipment medical institutions must be approved by the health plan department at or above the provincial level, and configure a license; It is clear that medical institutions are not allowed to configure the penalties for using large equipment without permission.
According to the new regulations on the supervision and administration of medical devices, since June 22 in suqian, or in violation of the "stop" measures of medical institutions in jiangsu province, light person will be warned, illegal incomes confiscated, fined 1-50000 yuan, the person that weigh will be fined for 5 to 10 times of the illegal income; Serious offenders will not be able to deploy any large medical equipment within five years.
Two large equipment configurations are being developed
This year may modify the regulations on the supervision and administration of medical devices is also an important content of the new, clearly put forward, the measures for the management of large medical equipment allocation by the who project department under the state council in conjunction with the relevant departments under the state council; The catalogue of large medical devices shall be submitted by the relevant department of the state council for the approval of the state council, and shall be submitted to the state council for approval.
The regulations on the supervision and administration of medical devices is the current "mother law" in the medical device industry. As its modification, industry experts said, the state department in charge of the next step is likely to make corresponding changes to the specific measures for the management of large equipment, a, b equipment item may also be adjusted.
The national health and family planning commission (NHFPC) is working with relevant departments to develop the management of large-scale medical equipment and the catalogue of large medical devices, according to a website of the city's health and family planning commission.
The change in the class ab equipment item, or related provisions configuration changes, in addition to affect the medical institutions, also directly affect the economic interests of the relevant medical equipment manufacturers, the blue parker equipment will be kept continuous attention to two new rules. |
