In recent years, under the promotion of multiple advantages such as encouraging innovative medical devices, marginal easing of centralized procurement policies, and supporting equipment renewal with financial discounted loans, the development of the domestic medical device industry is accelerating
.
At the same time, under the background of the continuous high enthusiasm of enterprises and the increasing investment in research and development, medical device innovation has also begun to accelerate
.
According to statistics, in 2022, more than 50 innovative medical device products have been approved for marketing
across the country.
For example, on December 15, Sino Medical announced that the company recently received the "Medical Device Registration Certificate of the People's Republic of China"
issued by the State Food and Drug Administration.
The product name is coronary balloon dilation catheter, which is the fourth coronary balloon dilation catheter product independently developed and produced by the company
.
Clinically, this coronary balloon catheter can be used for dilation of stenosis lesions and as a pre-dilation prior to PCI stent implantation
.
The approval of this product will provide clinicians with a more diverse range of devices in coronary interventional treatment
.
On the same day, a medical announcement was issued that the company's endovascular ultrasound diagnostic equipment has been approved by the State Medical Products Administration and recently obtained a medical device registration certificate
.
The disposable endovascular ultrasound diagnostic catheter of Shanghai Aisheng Biomedical Technology Co.
, Ltd.
, a wholly-owned subsidiary of the company, has also been approved by the State Medical Products Administration and recently obtained a medical device registration certificate
.
On November 30, Lepu Medical announced that the disposable pressure microcatheter independently developed by the company has recently obtained the registration approval of the State Medical Products Administration and obtained the registration certificate
of Class III medical devices.
The product is expected to measure the pressure of coronary artery lesions in adult patients during coronary angiography and/or interventional procedures, and is suitable for primary lesions with a visual degree of stenosis of 40% to 80% stenosis and a diameter of ≥ 2.
5 mm in the reference vessel of the stenosis segment of coronary angiography, and is intended for use by qualified and experienced medical technicians in medical institutions
.
On November 29, MeCan Biologics announced that Ningbo Meikang Shengde Biotechnology Co.
, Ltd.
("Sidley Biotechnology"), a wholly-owned subsidiary of the Company, recently obtained the "Medical Device Registration Certificate" issued by the Zhejiang Provincial Drug Administration, which is: "Automatic Chemiluminescence Immunoassay Analyzer"
.
The product uses acridine-based direct chemiluminescence in conjunction with supporting detection reagents for the qualitative or quantitative detection
of analytes in serum, plasma, whole blood and urine samples derived from humans.
On November 25, Aipeng Medical announced that the company's wholly-owned subsidiary, Aipeng Medical Technology (Hunan) Co.
, Ltd.
, recently obtained the "Medical Device Registration Certificate"
issued by the Hunan Provincial Drug Administration.
The product name is fixed holding anti-snoring device, the scope of application can extend the patient's jaw forward, used for the adjuvant treatment
of sleep snoring or obstructive apnea.
.
.
.
.
.
.
It can be seen from the above that the research and development and industrialization of domestic innovative medical devices have entered the fast lane
.
In view of the current policy determination of the pharmaceutical industry to collect procurement and control fees, "innovation" is expected to be the main theme
of the development of the domestic equipment industry for a long time in the future.
It is understood that the "14th Five-Year Plan" medical equipment industry development plan emphasizes 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.
In this regard, the industry believes that due to favorable policies, the development of China's medical device industry will enter a golden period
of development.
It is worth noting that in this context, relevant enterprises should accelerate the completion of short boards, forge long boards, and penetrate the industrial chain in order to achieve faster and longer-term development
.
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