A batch of medical device registration certificates have been cancelled!

The medical device industry is the core resource of the medical ecological supply si.
In recent years, the state has successively issued a series of favorable policies to support the development and growth of the medical device industry, and the entire medical device market has a bright prospe.
However, it should be noted that under the background of continuous improvement of development, the concentration of the entire industry is constantly increasing, and the supervision it faces is becoming more and more stri.
It is reported that in this context, a large number of machinery companies have begun to voluntarily cancel the medical device registration certifica.
Recently, the website of the State Drug Administration issued an announcement (.
37, 2022) on the cancellation of the medical device registration certifica.
The device registration certificate was cancell.
On April 25, the State Food and Drug Administration announced that in accordance with the "Regulations on the Supervision and Administration of Medical Devices", the medical device registration certificate for cannulated bone screws of Beijing Tianzhihang Medical Technology .
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(registration certificate number: National Machinery Note 2018346004
On April 21, the Henan Provincial Drug Administration issued an announcement (.
46, 2022) on the cancellation of the registration certificate of medical device products, stating that in accordance with the "Regulations on the Supervision and Administration of Medical Devices", according to the application of the enterprise, Yuan (Henan) is now cancell.
) The medical device registration certificate of the medical protective mask (registration certificate number: Yuji Zhuzhun 20202140389) product of the holding compa.
In addition to the above enterprises, the Nanning Market Supervision and Administration Bureau has recently decided to cancel the "Class I Medical Device Products" of Guangxi Haozun Medical Devices .
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Record (record number: Guinan Machinery Equipment .
20180061), "First Class Medical Device Production Record Certificate" (record number: Guinan Food and Drug Administration Equipment Production .

20180016) and "Medical Device Entrusted Production Record Certificat.

In addition, Anhui Saipu Environmental Protection Technology .

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took the initiative to apply for cancellation of the product registration certificate to the Anhui Provincial Drug Administrati.

According to the "Regulations on the Supervision and Administration of Medical Devices", one "Medical Device Registration Certificate" held by the company has also been cancelled in accordance with the l.

On the whole, most of the companies whose registration certificates have been revoked recently applied voluntari.

In this regard, the industry believes that this is mainly due to the continuous increase in the concentration of the medical device industry and the continuous tightening of market supervisi.

Medical devices are related to people's health and life safety, and are related to the overall situation of national economic and social developme.

According to data, there are currently more than 25,000 medical device manufacturers and more than 897,000 operating companies across the count.

In addition, in 2019, the main operating income of medical devices nationwide has reached more than 720 billion yuan, accounting for about 20% of the global medical device mark.

Therefore, with the continuous development of the economic level and the increasing demand for health, while China's medical device market will usher in huge development opportunities, the domestic supervision of the medical device industry is also constantly tighteni.

In recent years, domestic relevant departments have been very frequent in sampling inspections of medical device compani.

Under the background of increasingly strict supervision and intensified market competition, all enterprises must strictly control the procurement of raw materials, select good suppliers, ensure product quality from the source, and prevent the risk of product quality problems; strictly implement and supervise Product release and control procedur.

In addition, it is necessary to focus on the suitability of the quality policy/objectives, the achievement of quality objectives; the conformity and stability of products; the effectiveness of continuous improvement measures in the collection, analysis and utilization of data; the degree of compliance of the documented system with the standards ; The degree of implementationof the document system, e.

But at the same time, this is undoubtedly a big challenge for companies with insufficient strength and products with weak technical competitivene.

At present, the industry generally believes that in the future, enterprises with independent research and development, innovation and development capabilities, and the ability to continuously break through new technologies and meet new needs are expected to stand out, and will win more development space while completing localization substitution and entering the international sta.

And equipment companies with insufficient strength will be eliminated at an accelerated pa.

During this period, a large number of medical device products will have their registration certificates cancell.

It will become the no.