23 Taiwan imported brand medical equipment has been locked!

According to the information of Yunnan Food and Drug Administration, after nearly a year of hard work and efforts, the bureau has locked in 23 imported color ultrasonic diagnostic equipment of an international brand for the purpose of refurbishing old medical equipment for smuggling. Among them, eight sets of smuggled refurbished medical equipment with a value of more than 7 million yuan have been handed over to the drug control department of the district for investigation.

At present, it is not yet clear what 23 brands and models were found to have been involved in the refurbishment of Doppler ultrasound in Yunnan Province. It is not yet clear what the source is.

Just last week (November 6), Weifang City, Shandong Province Food and Drug Administration has opened 21 administrative penalties information, Weifang City, two medical institutions suspected of using undocumented medical equipment and was punished.

One is a township hospital and one is a county-level people hospital , The color ultrasonic diagnostic apparatus (model: LOGIQ P6) used were all found as unregistered medical devices.

In accordance with the relevant provisions of Article 66 of the "Regulations on the Supervision and Administration of Medical Devices," two medical institutions are all allowed to confiscate the illegal use of ultrasound and avoid other penalties.

Weifang City cases involved in the two color Doppler ultrasound, from the model LOGIQ P6 point of view, is GE's brand.

In Hubei Province, this year there were also ultrasound-related devices used by hospitals under the brand names GE GEI, LOGIQ P5 and Vivid E9, which were found to be refurbished medical devices. The product registration number on the Chinese nameplate is invalid.

In Guizhou Province, late last month, a hospital was also issued a ticket because of the purchase and use of an 'ultrasonic diagnostic apparatus' that was not legally registered.

The hospital to 72 million purchase mark for the GE brand Voluson E6 Choi Chao, the investigation is to have been using the old equipment for many years been refurbished, the product serial number does not exist, the Chinese nameplate is forged. It's

In the current "Regulations on the Supervision and Administration of Medical Devices", there are provisions: medical device management enterprise , The use of units shall not operate, the use of registration in accordance with the law, without qualified documents and expired, invalidated, out of medical equipment.

And on October 31, the State Administration of Drug Control of the People's Republic of China promulgated the Amendment to the Regulation on the Supervision and Administration of Medical Devices (Draft Draft for Comment) on its official website. It is proposed to add another provision: Medical device operators shall not operate medical devices that have been used.

The draft for soliciting opinions also clarified the related legal responsibility to be investigated and dealt with the medical devices that have been used, the light ones were ordered to be rectified, the illegally-operating medical devices were confiscated, and the heavier ones were also fined. If the circumstances are serious, they shall be ordered to suspend business until Revocation of business license.

From a fine, the old medical equipment, the value of more than 10,000 yuan, is the amount of fines can be 5 times to 10 times the amount.

Investigate the old medical equipment smuggling, renovation, sales, re-use of the intensity, more and more.