More than 300 medical equipment enterprises in the 4 clean-up areas were cancelled

Wuhan: 108 medical device operating companies were cancelled

According to the Wuhan Food and Drug Administration, this year, the bureau carried out a comprehensive clean-up of the city's pharmaceutical medical device business enterprises, and found that a group of pharmaceutical medical device operating enterprises have not applied for renewal of the certificate at the expiration of the validity period, do not have the original business license conditions, and the business is terminated. Or abnormal circumstances such as legal closure.

According to the provisions of Article 26 of the Measures for the Administration of Pharmaceutical Business Licenses and Article 39 of the Measures for the Supervision and Administration of Medical Device Management, the Wuhan Municipal Bureau decided to cancel the 18th branch of Hubei Tianlong Pharmacy Chain Co., Ltd., etc. 96 The "Pharmaceutical Business License" of the drug retail enterprise, the "Medical Device Business License" for 108 medical device wholesale and retail enterprises such as Wuhan Yuanjing Trading Co., Ltd. was cancelled.

Nanjing: More than 120 medical device operating companies were cancelled

According to the website of the Nanjing Food and Drug Administration, since the beginning of 2016, the bureau has issued a public notice for the cancellation of the "Medical Device Business License" almost every month.

Among them, 4 were issued in June, and the “Medical Device Business License” of 11 companies was cancelled; in May, 4 were issued, and the licenses of 15 operating enterprises were cancelled; on April 3, 48 were cancelled, and March was cancelled; 7 public notice, canceled 53; public on February 3, canceled 5...

The number of medical device operators involved in the above public announcements adds up to more than 120.

Gansu: 46 medical device operating enterprises were cancelled

The Gansu Provincial Food and Drug Administration issued two announcements on June 12 this year, and cancelled the “Medical Device Business License” of nine enterprises. In May, 4 announced that 14 medical device operating companies had been cancelled. Four were cancelled in February and 15 were cancelled in January.

In addition, this year the provincial Food and Drug Administration has written off the "Medical Device Business License" of 46 companies.

Hohhot: 109 medical device operating companies were cancelled

In order to further rectify and standardize the market order of medical device operators and improve the mechanism of enterprise withdrawal, the Food and Drug Administration of Hohhot, Inner Mongolia Autonomous Region, has carried out the work of rectifying and rectifying the operating enterprises holding the “Medical Device Business Enterprise License”.

The bureau issued a 30-day public notice in March this year, a one-time license for the "Medical Device Business Enterprise License", "Medical Device Business License", or "Second Medical Device Operation Record Certificate" for 109 companies. Can be written off.

Of the 109 companies, only 4 were actively applying for cancellation, and the rest were all expired but the license was expired and was cancelled according to law.

Not only in Hohhot, but also in Nanjing, many of the companies that were cancelled were expired and were not renewed and were cancelled.

In the announcement of the large-scale rectification of the medical device circulation field issued by the CFDA this month, unlicensed operation or certification of the behavior of non-renewal and still operating is one of the key points of rectification. Judging from the above-mentioned places that have been cleaned up, I am afraid that the results of the CFDA's medical equipment circulation will be less optimistic. The so-called 180,000 medical device business enterprises, if you really clean up, how much can you keep?

According to the Regulations on the Supervision and Administration of Medical Devices, if the medical device business license expires after the expiration of the validity period and continues to be engaged in medical device operations, the following administrative penalties will be imposed: confiscation of illegal income, confiscation of illegal medical devices If the value of the goods is less than 10,000 yuan, the fine is 50,000-100,000; if the value is more than 10,000, the fine is 10-20 times the amount of the goods; if the circumstances are serious, the medical device license will not be granted within 5 years. Proof.

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