Another innovative medical device has been approved for marketing, and 16 have been approved during the year

In recent years, with the support of favorable policies, the number of approvals of innovative medical devices in China has shown a rapid upward trend
.
A total of 35 innovative medical devices will be launched in 2021, hitting a new high in previous years
.
Entering 2022, the speed of approval and listing of innovative medical devices is still accelerating
.
Recently, another innovative medical device has been approved for listing
.
According to the public information of the State Food and Drug Administration, the innovative medical device "Magnetic Resonance Imaging System" produced by Xingaoyi Medical Equipment Co.
, Ltd.
has been approved for listing
.
According to reports, the product is composed of superconducting magnet (1.
5T), scanning bed, spectrometer, radio frequency system, gradient system, operating table, isolation transformer, transmitting coil, gradient coil, respiratory gating, and radio frequency receiving coil for clinical MRI.
Image diagnosis
.
The main innovation of this product is the use of liquid nitrogen-free superconducting magnet technology, which uses a refrigerator to conduct direct conduction cooling
.
Compared with the conventional superconducting magnetic resonance product that uses liquid nitrogen to cool the superconducting coil in the magnet, the product has the advantages of lower production and use cost, simplified magnet structure, and reduced magnet weight
.
At present, the two key technologies of the product have applied for invention patents in China and have entered the substantive examination stage
.
The State Food and Drug Administration also released a list of approved innovative medical devices
.
According to the list, the "Magnetic Resonance Imaging System" is the 16th innovative medical device approved this year
.
Among them, in March, the innovative medical devices approved for marketing included CT image-assisted triage software for intracranial hemorrhage and a mobile head and neck magnetic resonance imaging system; in February, the gastrointestinal vibration capsule system was approved for marketing; in January, there were Laparoscopic endoscopic surgery system, dual-channel implantable deep brain stimulation pulse generator set, implantable deep brain stimulation electrode lead set, implantable deep brain stimulation extension lead set equipment, straight thoracic aorta Covered stent system, neurosurgery navigation and positioning system,
etc.
Innovative medical devices are medical devices with high threshold and obvious clinical application value
.
In 2014, the State Food and Drug Administration opened a green channel for innovative medical devices, giving priority to review and approval under the premise that the standards and procedures are not reduced
.
In February 2014, the State Food and Drug Administration issued the Special Approval Procedures for Innovative Medical Devices (Trial), which set up a fast-track approval channel for innovative medical devices and encouraged the research and development of innovative medical devices
.
Judging from the data of innovative devices approved for marketing from 2014 to 2021, 1, 9, 11, 12, 21, 19, 26, and 35 were approved respectively
.
According to statistics, as of April 7, 2022, China has approved 150 innovative medical device products
.
From the data, it can be seen that the number of innovative medical devices approved for listing in China is increasing year by year
.
However, due to the high threshold, from the perspective of overall medical device approval data, the number of innovative medical devices listed each year is still relatively small
.
As of the end of 2021, there have been more than 2,200 applications for special approval for innovative medical devices, and 134 products have been approved for marketing, with an approval rate of only 5.
2%
.
From the perspective of the industry, domestic innovative medical devices need to have hard power to enter the green channel, which greatly reduces the approval time, so as to ensure that products can enter the market as soon as possible, increase the competitiveness of products, and are expected to seize market opportunities
.
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.