As the medical device industry prospers forward, many of its drawbacks and problems have gradually emerged. With the exposure of the problem, the State and the food and drug administrations of various provinces have also frequently shot. Words such as surveillance, flight inspection, confiscation of GSP certificates, and suspension of production have been ubiquitous. This 2015 medical circle can be described as a change.

CFDA flight inspection 7 mechanical enterprises were fined for production

In September 2015, the State Food and Drug Administration organized flight inspections for medical device manufacturers. It is reported that the flight inspection involved Liaoning, Anhui, Hubei and Guangzhou provinces, among which seven medical device companies were fined for production.

Gansu Food and Drug Administration routinely inspected 13 armed enterprises

On September 25, 2015, the Gansu Provincial Food and Drug Administration found that 13 medical device operating companies were suspected of arbitrarily changing their business premises during daily supervision and inspection.

According to the "Regulations on the Supervision and Administration of Medical Devices" and the "Measures for the Supervision and Administration of Medical Device Management" and other relevant regulations, 13 medical device operating enterprises such as Gansu Feidu Zhenghe Trading Co., Ltd., which are suspected of arbitrarily changing the business premises, are determined (see the list of notified enterprises for details). To be notified. If an enterprise that fails to apply for a change in the relevant administrative licensing items within one month is revoked, its Medical Device Operating Enterprise License will be revoked according to law.

Thousands of enterprises in Shandong Province were fined

To say the strength and breadth of the attack, the Shandong Food and Drug Administration is definitely not a fuel-efficient lamp. It is understood that as of August 31, Shandong Food and Drug Administration has completed the phased remediation of decorative color flat contact lenses, condoms, experiential business practices, in vitro diagnostic reagents, customized dentures and disposable sterile medical devices. Work tasks have achieved remarkable results.

The inspection of the province a total of 497 production enterprises, 16,271 business enterprises, 756 tourist hawkers, 18,692 users, warned to rectify 4,048 (renovation rate of 11.2%), ordered to suspend production and business 1022 (discontinuation rate of 2.8) %), filed 853.

By the end of August, 853 cases had been filed, 724 cases had been closed, and 13.478 million yuan had been fined and punishable. There were 4 cases involving more than 100,000 yuan and 16 cases with more than 50,000 yuan.

13 mechanical enterprises in Jiangsu Province were “under the horse”

Compared with Shandong Province, the punishment measures in Jiangsu Province are even more rampant. Shandong Province is more or less imprisoned for mechanical enterprises. Look at Jiangsu again, the machinery enterprises are directly "squatting under the horse"

On October 10, 2015, Jiangsu Food and Drug Administration issued the No. 15 announcement on the cancellation of the license for medical device manufacturing enterprises, and five others were cancelled. So far, Jiangsu has issued three batches of “deregistration announcements” this year, and a total of 13 medical device manufacturers have been canceled production licenses. The enterprises that have been cancelled will have to re-produce the medical device products, and the original "Medical Device Product Registration Certificate" will be invalidated at the same time.

Inspected by various provinces, large machinery enterprises will be shuffled

According to incomplete statistics, as of the end of October 2015, there were more than 20,000 devices inspected nationwide, and there were far more than 5,000 mechanical enterprises that ordered rectification, fines, suspension of production, and cancellation of production licenses.

Although the state and the provincial governments have invested a lot of energy to rectify the machinery enterprises, the problems of commercial bribery and high prices are still emerging. It is expected that the government and the procuratorate will intensify inspections in the future, and issue various related policies to solve the problems. It seems that the era of large reshuffle in the medical machinery circle is coming.

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