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According to the statistics of Zhongcheng Digital (formerly Zhongcheng Medical Equipment), the number of medical equipment products entering the priority approval channel nationwide in 2021 will reach 208, a year-on-year decrease of 12.
2%
.
Among them, there are 196 and 12 Class II and III products respectively, and 34 products have been approved
.
Data source: Zhongcheng Digital (formerly Zhongcheng Medical Equipment), Medical Device Innovation Network Provincial and City Ranking From the perspective of the distribution of products in provinces and cities, Tianjin has the largest number of products entering the Class II priority approval channel, with 66 products ranking first Ranked second with 55 cases in Chongqing, and third with 44 cases in Anhui Province
.
Class III products are the most in Shanghai, with 3 products, and 1 product from Guangdong Province, Fujian Province, and Jiangsu Province has entered the priority approval
.
Data source: Zhongcheng Digital Branch (formerly Zhongcheng Medical Equipment), Medical Device Innovation Network Data source: Zhongcheng Digital Branch (formerly Zhongcheng Medical Device), Medical Device Innovation Network A total of 34 medical device products will be given priority approval in 2021 , distributed in 7 provinces, the largest is Tianjin, a total of 13 Class II products have received priority approval, and Chongqing has a total of 9 Class II products
.
In addition, both Shanghai and Guangdong Province have one Class III product that has passed the priority approval channel
.
Data source: Zhongcheng Digital (formerly Zhongcheng Medical Equipment), Medical Device Innovation Network Subdivisions From the perspective of subdivisions, in 2021 will enter the priority approval channel and the largest number of approvals will still be in vitro diagnostic reagents, with a total of 100 pieces The products entered the approval channel, and another 19 Class II products and 4 Class III products were approved, both the number entering the channel and the number of approved products accounted for more than 50% of the total
.
The number of Class II products approved for clinical inspection equipment, medical imaging equipment and medical rehabilitation equipment is 6, 3 and 2 respectively; dental equipment, passive surgical equipment, traditional Chinese medicine equipment and passive implantable equipment are all 1 piece Approved
.
The approved Class III products are also medical imaging devices (3 pieces), passive implantable devices (2 pieces), medical software (1 piece), physical therapy devices (1 piece), neurological and cardiovascular surgical devices (1 piece) )
.
Data source: Zhongcheng Digital (formerly Zhongcheng Medical Equipment), Medical Device Innovation Network Data source: Zhongcheng Digital (formerly Zhongcheng Medical Device), Medical Device Innovation Network Industrial Park In 2021, there are 6 industrial parks with a total of 24 cases Class II products have entered the national priority approval channel for medical devices, and all have been approved
.
Among them, a total of 12 products have been approved in Tianjin Medical and Medical Device Industrial Park, the largest number, including 10 products such as β-collagen special sequence calibrator and type I collagen amino-terminal extension peptide calibrator
.
Data sources: Zhongcheng Digital (formerly Zhongcheng Medical Equipment), Medical Device Innovation Network Enterprise Analysis In terms of enterprises, there are 84 enterprises entering the national priority approval channel for medical devices, with a total of 205 products
.
Among them, Tianjin Huaketai Biotechnology Co.
, Ltd.
received the largest number of Class II priority approvals with 12, followed by Chongqing Zhongyuan Huiji Biotechnology Co.
, Ltd.
, Anhui Enhe Biotechnology Co.
, Ltd.
and Chongqing Xishan Technology Co.
, Ltd.
7, 4 and 2 respectively, and 1 for other companies
.
There are only two companies that have received Class III priority approval, namely Guangdong Jiayue Meishi Biotechnology Co.
, Ltd.
and Shanghai United Imaging Medical Technology Co.
, Ltd.
The approved products are collar-type artificial cornea and magnetic resonance imaging system respectively
.
Data source: Zhongcheng Digital (formerly Zhongcheng Medical Equipment), Medical Device Innovation Network
2%
.
Among them, there are 196 and 12 Class II and III products respectively, and 34 products have been approved
.
Data source: Zhongcheng Digital (formerly Zhongcheng Medical Equipment), Medical Device Innovation Network Provincial and City Ranking From the perspective of the distribution of products in provinces and cities, Tianjin has the largest number of products entering the Class II priority approval channel, with 66 products ranking first Ranked second with 55 cases in Chongqing, and third with 44 cases in Anhui Province
.
Class III products are the most in Shanghai, with 3 products, and 1 product from Guangdong Province, Fujian Province, and Jiangsu Province has entered the priority approval
.
Data source: Zhongcheng Digital Branch (formerly Zhongcheng Medical Equipment), Medical Device Innovation Network Data source: Zhongcheng Digital Branch (formerly Zhongcheng Medical Device), Medical Device Innovation Network A total of 34 medical device products will be given priority approval in 2021 , distributed in 7 provinces, the largest is Tianjin, a total of 13 Class II products have received priority approval, and Chongqing has a total of 9 Class II products
.
In addition, both Shanghai and Guangdong Province have one Class III product that has passed the priority approval channel
.
Data source: Zhongcheng Digital (formerly Zhongcheng Medical Equipment), Medical Device Innovation Network Subdivisions From the perspective of subdivisions, in 2021 will enter the priority approval channel and the largest number of approvals will still be in vitro diagnostic reagents, with a total of 100 pieces The products entered the approval channel, and another 19 Class II products and 4 Class III products were approved, both the number entering the channel and the number of approved products accounted for more than 50% of the total
.
The number of Class II products approved for clinical inspection equipment, medical imaging equipment and medical rehabilitation equipment is 6, 3 and 2 respectively; dental equipment, passive surgical equipment, traditional Chinese medicine equipment and passive implantable equipment are all 1 piece Approved
.
The approved Class III products are also medical imaging devices (3 pieces), passive implantable devices (2 pieces), medical software (1 piece), physical therapy devices (1 piece), neurological and cardiovascular surgical devices (1 piece) )
.
Data source: Zhongcheng Digital (formerly Zhongcheng Medical Equipment), Medical Device Innovation Network Data source: Zhongcheng Digital (formerly Zhongcheng Medical Device), Medical Device Innovation Network Industrial Park In 2021, there are 6 industrial parks with a total of 24 cases Class II products have entered the national priority approval channel for medical devices, and all have been approved
.
Among them, a total of 12 products have been approved in Tianjin Medical and Medical Device Industrial Park, the largest number, including 10 products such as β-collagen special sequence calibrator and type I collagen amino-terminal extension peptide calibrator
.
Data sources: Zhongcheng Digital (formerly Zhongcheng Medical Equipment), Medical Device Innovation Network Enterprise Analysis In terms of enterprises, there are 84 enterprises entering the national priority approval channel for medical devices, with a total of 205 products
.
Among them, Tianjin Huaketai Biotechnology Co.
, Ltd.
received the largest number of Class II priority approvals with 12, followed by Chongqing Zhongyuan Huiji Biotechnology Co.
, Ltd.
, Anhui Enhe Biotechnology Co.
, Ltd.
and Chongqing Xishan Technology Co.
, Ltd.
7, 4 and 2 respectively, and 1 for other companies
.
There are only two companies that have received Class III priority approval, namely Guangdong Jiayue Meishi Biotechnology Co.
, Ltd.
and Shanghai United Imaging Medical Technology Co.
, Ltd.
The approved products are collar-type artificial cornea and magnetic resonance imaging system respectively
.
Data source: Zhongcheng Digital (formerly Zhongcheng Medical Equipment), Medical Device Innovation Network
