Recently, a news disclosed on the website of the Shenzhen Market Supervision Bureau that a company was fined more than 160,000 yuan for producing Class II medical devices that did not meet the technical requirements of the product attracted attention and heated discussions
in the industry.
Medical devices are products related to human health and safety, and their production and operation should meet the corresponding requirements to protect the rights and interests
of consumers.
Recently, many enterprises producing unqualified medical devices have been "exposed"
.
For example, on November 23, an administrative punishment information published on the website of the Hunan Provincial Drug Administration (the administrative penalty decision showed that a medical protective mask produced by a medical device company in Hunan that did not meet the requirements of mandatory standards was fined
720,000 yuan.
News on November 9, an administrative penalty information released by the Tianjin Food and Drug Administration showed that a medical device co.
, LTD.
in Tianjin was fined 30,000 yuan
by the Tianjin Drug Administration for failing to rectify, stop production and report in accordance with the provisions due to changes in production conditions and no longer meeting the requirements of the medical device quality management system.
Judging from public information, some companies have even been fined millions of yuan
.
For example, in September this year, the Shanghai Pudong New Area Market Supervision Administration imposed an administrative penalty
on a foreign company.
For the company's production, operation and use of medical devices that did not meet mandatory standards or did not meet the technical requirements of registered or filed products, the Shanghai Pudong New Area Market Supervision Administration imposed a fine of 1.
4535 million yuan and ordered corrections
.
It is worth mentioning that not only enterprises that produce and sell unqualified medical devices will be fined, but also hospital institutions that use unqualified medical devices
.
On November 10, the Wuxi Municipal Administration for Market Regulation issued a penalty decision
.
The special column of credit information publicity such as administrative licensing and administrative punishment of Wuxi Market Supervision Administration stipulates that a hospital in Wuxi is suspected of using unregistered medical devices without qualified certification documents, Article 89 of the Regulations on the Supervision and Administration of Medical Devices, and shall be fined 62,000 yuan
.
In mid-November, an administrative penalty decision with the document number "Handan Municipal Supervision Punishment (2022) (CT) No.
020053" showed that a medical beauty salon company was fined 20,000 yuan
for failing to establish and implement medical device purchase inspection records in accordance with regulations.
Also in November, the Shiquan County Market Supervision Administration issued an administrative penalty against a hospital (Shishi Jian Penalty [2022] No.
166), and the administrative penalty decision showed that the company was fined 10,000 yuan
for using invalid medical devices.
In recent years, China's medical device industry has developed rapidly, and with the release of favorable policies such as the "Healthy China 2030" Planning Outline, the industry expects that the industry will usher in a golden period
.
From the perspective of the domestic market, many enterprises are also increasing R&D and innovation, constantly developing in a high-end direction, and accelerating the pace
of import substitution.
The "14th Five-Year Plan" medical equipment industry development plan proposes that by 2025, the medical equipment industry should achieve advanced foundation, significantly improve the modernization level of the industrial chain, basically achieve effective supply of mainstream medical equipment, significantly improve the performance and quality level of high-end medical equipment products, and initially form a comprehensive support capacity
for public health and medical health needs.
Data show that the size of China's medical equipment market was 370 billion yuan in 2016 and increased to 765.
5 billion yuan by 2020, with an average annual compound growth rate of 19.
9%.
Considerable growth
is expected in the future.
In this context, it is very important to keep the quality of products, and with the increase of market rectification, it is believed that it will wake up the industry
.
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