Medical network - on November 22nd November 16, lanzhou city, gansu province food and drug administration issued notice, for the six medical equipment management enterprise shall be reported violation behavior.
The serial number enterprise name Business license number
1 din in lanzhou xinyuan electronic technology co., LTD. (2014) no. 010176
2 lanzhou Oriental hesheng trading co., LTD. (2012) no. 010227
3 space-based power in gansu province medical instrument co., LTD. (2012) no. 010130
4 gansu TRW electronic technology co., LTD. (2012) no. 010065
5 3 leaf in gansu province medical equipment co., LTD. (2012) no. 010155
6 to gansu hui source trading co., LTD. (2012) no. 010105
Lanzhou city food and drug administration found in the daily supervision and inspection, the above six medical equipment management enterprise alleged change behavior of business premises without authorization.
To further standardize the market order of medical equipment, in accordance with the administrative licensing law of the People's Republic of China regulations on the supervision and administration of medical devices and the measures for the supervision and administration of medical devices management regulations, lanzhou food safety requirements:
Within 15 working days from now on, the relevant enterprises to belonging to food safety investigation processing, and medical equipment business license in accordance with the relevant provisions, handle licensing items related to change in accordance with the law. Delayed in processing and surveyed don't deal with relevant licensing items change, the lanzhou city bureau will be in accordance with the cancellation of this enterprise the medical equipment business license.
In the current local in check by the agency for medical device operation enterprise, "change management place" is a common problem. The corresponding and expand the scope of business without authorization, etc. And, in fact, these are easily machinery dealers "ignore" problems, are illegal.
The measures for the supervision and administration of medical devices management made clear provisions in article 54:
Any of the following circumstances, the food and drug supervision and administration departments at or above the county level shall order correction, a fine of not more than 10000 yuan and 30000 yuan:
(a) medical equipment management enterprise operating conditions change, no longer meet the demands of medical equipment management and the quality control standard, and not in accordance with the provisions of the rectification;
(2) of the medical equipment management enterprise change management place or warehouse address, expand the scope of business without authorization or set up warehouses;
(3) engaged in the management of medical equipment wholesale business of the company sales to not have a qualification of the enterprise or the use of units;
(4) never has the qualification of medical equipment management enterprise production and management enterprises purchase of medical apparatus and instruments.
So, not surprisingly, lanzhou city after the above 6 companies under investigation, will also be a fine of 10000 yuan to 30000 yuan. |
