Driven by multiple advantages such as encouraging innovative medical devices, easing the marginal of centralized procurement policies, and supporting equipment renewal with financial discounted interest loans, the development of the domestic medical device industry is accelerating, and domestic medical devices have gradually begun to usher in a harvest period, and products are constantly on the market
.
On January 4, MeCan Biotech announced that Jiangxi Meikang Shengde Biotechnology Co.
, Ltd.
, a holding subsidiary of Meikang Biotechnology, recently obtained the medical device registration certificate (in vitro diagnostic reagent)
issued by the Jiangxi Provincial Drug Administration.
Products include valproic acid and carbamazepine detection kits (liquid chromatography-tandem mass spectrometry), valproic acid, and carbamazepine controls
.
Valproic acid and carbamazepine detection kits (liquid chromatography-tandem mass spectrometry) are used for in vitro quantitative detection
of valproic acid and carbamazepine concentrations in human serum.
Valproic acid and carbamazepine controls are used with the accompanying valproic acid and carbamazepine detection kit (liquid chromatography-tandem mass spectrometry) for quality control
during the quantitative determination of valproic acid and carbamazepine in human serum.
It is worth noting that in the context of the continuous listing of domestic medical device products, it can be clearly found that domestic medical device companies are continuously improving in terms of product quality, innovation and technical content, and the research and development and industrialization of innovative medical devices have also entered the fast lane
.
It is reported that a large number of innovative products of enterprises have recently obtained medical device registration certificates
.
For example, on December 30, 2022, the State Food and Drug Administration approved the registration application
for the innovative product "Medical Angiography X-ray Machine" produced by United Imaging Medical.
According to the State Food and Drug Administration, the product adopts a 9-axis robot DSA, which can realize cone beam imaging of the whole abdomen and chest, and solve the problem of small field of
view reconstructed by traditional cone beam CT.
In addition, the product uses computer vision technology to reduce radiation exposure and intraoperative procedures
.
Compared with traditional medical angiography X-ray machines, this product can significantly expand the field of view of cone beam CT reconstruction, reduce the operation steps, operation time and radiation dose of cone beam CT scan, and is expected to shorten the preparation time before imaging and improve the surgical efficiency
.
In early December 2022, the NMPA also approved the registration application
for the innovative product "Single-use Pressure Monitoring Magnetic Positioning RF Ablation Catheter" produced by Microelectrophysiology.
The product can measure the contact pressure value between the catheter tip and the heart wall in real time, better assist the surgeon to complete the operation, effectively prevent the incomplete ablation caused by steam bursting caused by excessive adhesion force between the catheter and the tissue during the operation, and shorten the learning curve of doctors and achieve a better long-term treatment success rate
.
In addition to the above products, a number of innovative medical device product registration applications such as disposable intravascular ultrasound diagnostic catheters and single-use pressure monitoring magnetic positioning radiofrequency ablation catheters have also been approved
by the State Food and Drug Administration.
According to incomplete statistics, in 2022, more than 50 innovative medical device products have been approved for marketing
across the country.
In this regard, industry insiders said that innovative medical devices are currently exempt from procurement with quantity, policy support for innovation is increasing, and the innovation momentum of domestic manufacturers is constantly being activated
.
In this context, "innovation" is expected to be the main theme
of the development of the domestic equipment industry for a long time in the future.
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