23 major brands imported medical equipment suspected of smuggling renovation

23 major brands imported medical equipment suspected of smuggling renovation

Release date: 2017-11-15

According to the Yunnan Provincial Food and Drug Administration, after nearly a year of hard work and one by one, the bureau has locked up 23 imported international color brands of imported color ultrasonic diagnostic equipment suspected of smuggling and renovating old medical equipment. Among them, 8 smuggled and refurbished medical equipment with a value of more than 7 million yuan have been investigated and handled by the drug supervision department of the jurisdiction.

At present, it is unclear what 23 brands and models are suspected of being smuggled and refurbished in Yunnan Province. It is also unclear what the source is.

Many provinces, some use medical equipment to find problems

Just last week (November 6), the Weifang City Food and Drug Administration of Shandong Province disclosed 21 administrative punishment information, and two medical institutions in Weifang were punished for alleged use of unlicensed medical equipment.

One is a township health center, and the other is a county-level people's hospital. The color ultrasound diagnostic apparatus (model: LOGIQ P6) used is detected as an unregistered medical device.

According to the relevant provisions of Article 66 of the Regulations on the Supervision and Administration of Medical Devices, both medical institutions have been confiscated for illegal use of color ultrasound and are exempt from other penalties.

The color ultrasound involved in the second phase of Weifang City is GE's brand from the model LOGIQ P6.

In Hubei Province, this year, there were also supermarkets using the GE brand, model LOGIQ P5 and Vivid E9. The color registration was identified as a refurbished medical device, and the product registration number on the Chinese nameplate was invalid.

In Guizhou Province, in the latter part of last month, a hospital was also issued a ticket for purchasing and using an "ultrasound diagnostic device" that was not legally registered.

The hospital purchased the logo for the GE brand Voluson E6 color ultrasound with a price of RMB 620,000. After investigation, the old equipment that has been used for many years was refurbished, the serial number of the product did not exist, and the Chinese nameplate was forged. In the end, the lottery was confiscated.

Operating old medical equipment, to be blocked, severely punished

In the current Regulations on the Supervision and Administration of Medical Devices, it has been stipulated that medical device operating enterprises and users shall not operate or use medical devices that have not been legally registered, have no certificate of conformity, and have expired, expired or eliminated.

On October 31, the State Food and Drug Administration hanged the "Amendment of the Regulations on the Supervision and Administration of Medical Devices (Draft for Soliciting Opinions)" on its official website, and it is proposed to add another provision: medical device operating enterprises may not operate medical devices that have already been used.

The draft for comments also clarified the issue of related legal liability investigations. The medical devices that have been used have been operated. The lighter ones are ordered to correct and confiscate the illegally operated medical devices, and the severe ones will be fined. If the circumstances are serious, the business shall be ordered to suspend business until the business license is revoked.

From the point of view of fines, if the old medical equipment is operated, the value of the goods is more than 10,000 yuan, which is 5 to 10 times the amount of the fine.

The intensity of investigations into the smuggling, refurbishment, sales, and reuse of old medical devices is growing.

Source: Medical Liaison Officer (Micro Signal MLOclub)

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