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In recent years, the speed of China's innovative medical device products is accelerating
.
According to statistics, from 2014 to 2021, the State Food and Drug Administration approved 1, 9, 11, 12, 21, 19, 26, and 35 innovative medical devices respectively, of which 2020 has already set a record A new high, an increase of 35% compared to 2020
.
A total of 134 innovative medical device products have been approved in 8 years
.
Entering 2022, there is good news that another batch of products will be launched
.
It is reported that from January to February 2022, the State Food and Drug Administration has approved 13 innovative medical device products for the market, exceeding the number from 2014 to 2017
.
In early March, the information released on the website of the State Food and Drug Administration showed that the "mobile head and neck magnetic resonance imaging system" produced by Foshan Ruijiatu Medical Technology Co.
, Ltd.
and the "digestive tract vibration capsule system" produced by Shanghai Anhan Medical Technology Co.
, Ltd.
These two innovative medical device products have also been approved for marketing
.
Among them, the digestive tract vibration capsule system consists of a disposable digestive tract vibration capsule, a configurator and a VCP software (VCP2.
1), which is suitable for the symptomatic relief of functional chronic transit constipation in adults with poor drug treatment effect.
Use under the guidance of a qualified physician
.
This product is a non-drug treatment and can be used as another treatment option for people with functional constipation
.
At the same time, its capsule has the ability to detect acceleration, and it can start the capsule by monitoring the change of the acceleration value
.
At present, there are no similar products on the market at home and abroad
.
The mobile head and neck MRI system consists of permanent magnet, gradient amplifier, gradient shim coil, radio frequency amplifier, radio frequency transmitting coil, head coil (optional), head and neck combined coil (optional), spectrometer, temperature controller, It consists of digital shimming unit, mobile device, shielding cover, hospital bed and alarm unit
.
Mainly used for head and neck clinical MRI (magnetic resonance imaging) diagnosis
.
The product is small in size and light in weight.
It can be deployed inside a medical institution with a fixed shield and connected to an external 220VAC/10A network power supply.
It can also be moved to different sites in a medical institution to perform close examinations on patients, expanding the scope of magnetic resonance products.
installation range
.
Up to now, the State Food and Drug Administration has approved 148 innovative medical devices to be marketed, which better meets the needs of the public
.
At the same time, in order to protect the safety of patients using equipment, the State Food and Drug Administration said that the national drug regulatory authorities will strengthen post-market supervision of these products
.
The author noticed that in addition to the products already on the market, there are also a number of innovative medical device application projects that have entered the special review process
.
For example, on March 1, the Center for Medical Device Evaluation (CMDE) of the State Food and Drug Administration issued the "Announcement of the Review Results of the Special Review Application for Innovative Medical Devices" (No.
2, 2022), which indicated that it intends to agree to Shenzhen Mindray Bio's "full Automatic peripheral blood cell morphology analyzer", "Transcatheter aortic valve system" of Peijia Medical (Suzhou), "anti-CD19-chimeric antigen receptor T cell detection kit (flow cytometer) of Shanghai Xingwan Biotechnology" 5 innovative medical devices, including Law-PE)", entered the special review process
.
According to statistics, from January 1 to March 1, 2022, 13 innovative medical device projects have entered the special review process
.
From the perspective of regional distribution, Beijing and Zhejiang have the most number, with 3 respectively; Shanghai and overseas are closely followed, with 2 respectively
.
In addition, Jiangsu, Guangdong, and Tianjin each have one
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
According to statistics, from 2014 to 2021, the State Food and Drug Administration approved 1, 9, 11, 12, 21, 19, 26, and 35 innovative medical devices respectively, of which 2020 has already set a record A new high, an increase of 35% compared to 2020
.
A total of 134 innovative medical device products have been approved in 8 years
.
Entering 2022, there is good news that another batch of products will be launched
.
It is reported that from January to February 2022, the State Food and Drug Administration has approved 13 innovative medical device products for the market, exceeding the number from 2014 to 2017
.
In early March, the information released on the website of the State Food and Drug Administration showed that the "mobile head and neck magnetic resonance imaging system" produced by Foshan Ruijiatu Medical Technology Co.
, Ltd.
and the "digestive tract vibration capsule system" produced by Shanghai Anhan Medical Technology Co.
, Ltd.
These two innovative medical device products have also been approved for marketing
.
Among them, the digestive tract vibration capsule system consists of a disposable digestive tract vibration capsule, a configurator and a VCP software (VCP2.
1), which is suitable for the symptomatic relief of functional chronic transit constipation in adults with poor drug treatment effect.
Use under the guidance of a qualified physician
.
This product is a non-drug treatment and can be used as another treatment option for people with functional constipation
.
At the same time, its capsule has the ability to detect acceleration, and it can start the capsule by monitoring the change of the acceleration value
.
At present, there are no similar products on the market at home and abroad
.
The mobile head and neck MRI system consists of permanent magnet, gradient amplifier, gradient shim coil, radio frequency amplifier, radio frequency transmitting coil, head coil (optional), head and neck combined coil (optional), spectrometer, temperature controller, It consists of digital shimming unit, mobile device, shielding cover, hospital bed and alarm unit
.
Mainly used for head and neck clinical MRI (magnetic resonance imaging) diagnosis
.
The product is small in size and light in weight.
It can be deployed inside a medical institution with a fixed shield and connected to an external 220VAC/10A network power supply.
It can also be moved to different sites in a medical institution to perform close examinations on patients, expanding the scope of magnetic resonance products.
installation range
.
Up to now, the State Food and Drug Administration has approved 148 innovative medical devices to be marketed, which better meets the needs of the public
.
At the same time, in order to protect the safety of patients using equipment, the State Food and Drug Administration said that the national drug regulatory authorities will strengthen post-market supervision of these products
.
The author noticed that in addition to the products already on the market, there are also a number of innovative medical device application projects that have entered the special review process
.
For example, on March 1, the Center for Medical Device Evaluation (CMDE) of the State Food and Drug Administration issued the "Announcement of the Review Results of the Special Review Application for Innovative Medical Devices" (No.
2, 2022), which indicated that it intends to agree to Shenzhen Mindray Bio's "full Automatic peripheral blood cell morphology analyzer", "Transcatheter aortic valve system" of Peijia Medical (Suzhou), "anti-CD19-chimeric antigen receptor T cell detection kit (flow cytometer) of Shanghai Xingwan Biotechnology" 5 innovative medical devices, including Law-PE)", entered the special review process
.
According to statistics, from January 1 to March 1, 2022, 13 innovative medical device projects have entered the special review process
.
From the perspective of regional distribution, Beijing and Zhejiang have the most number, with 3 respectively; Shanghai and overseas are closely followed, with 2 respectively
.
In addition, Jiangsu, Guangdong, and Tianjin each have one
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
