Release date: 2015-08-14
On February 7, 2014, the General Administration of the State Council established the “Special Approval Process for Innovative Medical Devices (Trial)†to encourage research and innovation organizations in medical devices. Then, the implementation of the "procedure" has been implemented so far, how about the application for approval throughout the country? For this reason, the medical device innovation network summarizes the products and enterprises entering the innovative medical device approval process in the first half of 2015. Details are as follows:
Serial number | product name | Apply for a business |
1 | Ablation catheter and nerve stimulation radiofrequency ablation instrument with accurate mapping of renal sympathetic nerve function | Suzhou Xinmai Medical Equipment Co., Ltd. |
2 | Constant temperature amplification microfluidic chip nucleic acid analyzer | Boao Bio Group Co., Ltd. |
3 | Children's intelligent control gastric lavage machine | Tianjin Tongye Technology Development Co., Ltd. |
4 | Drug-eluting peripheral balloon dilatation catheter | Beijing Xianruida Medical Technology Co., Ltd. |
5 | SMN1 gene exon deletion detection kit (fluorescence quantitative PCR method) | Shanghai Five-color Stone Medical Research Co., Ltd. |
6 | Three-dimensional cardiac electrophysiology mapping system | Shanghai Wei Chuang Electrophysiology Medical Technology Co., Ltd. |
7 | Three-layer bionic small-caliber artificial blood vessel | Wuhan Yangsen Biotechnology Co., Ltd. |
8 | Intraocular lens | Aibo Nuode (Beijing) Medical Technology Co., Ltd. |
9 | Interventional artificial heart valve | Jiangsu Suzhou Jiecheng Medical Technology Co., Ltd. |
10 | Three aPCS type corneal stroma substitutes | Qingdao Zhonghao Biological Engineering Co., Ltd. |
11 | Positron emission tomography apparatus | Mingfeng Medical System Co., Ltd. |
12 | Red blood cell life tester | Shenzhen Xianya Biotechnology Co., Ltd. |
13 | Surgical robot positioning system | Beijing Tianzhihang Medical Technology Co., Ltd. |
14 | Surgical biopsy (for bladder and abdominal wall repair) | Shanghai Songli Biotechnology Co., Ltd. |
15 | Medical artificial nerve graft | Jiangsu Yitong Biotechnology Co., Ltd. |
On the basis of the table, the Medical Machinery Innovation Network summarizes and analyzes the characteristics currently presented in the special approval of innovative medical devices:
First, the company is mainly in the Yangtze River Delta region
As can be seen from the above summary table, the manufacturers applying for the approval of innovative medical devices are mainly distributed in the Yangtze River Delta Economic Zone, which is dominated by Shanghai and Suzhou. The two provinces add up to six enterprises, followed by the Bohai Economic Zone, which is dominated by Beijing and Tianjin. Lord, there are 4 companies in Beijing that have entered the special examination and approval of innovative medical devices. There is one in Tianjin. However, from the table, there are very few manufacturers in the first half of this year that have passed the examination of innovative medical devices in the inland provinces, only one in Wuhan. But this is not surprising, because this status quo is closely linked to China's economic development. In other words, the more developed the economy and the more advanced the technology, the easier it is to become the main source of innovative medical device development in China.
Second, the speed of innovation approval
Since the implementation of the "Program", a total of 11 projects have been approved in 2014. In the first half of 2015, a total of 15 innovative medical device approvals were approved, which indicates that the state's approval of innovative medical devices is getting faster and faster. Obviously, this is also the meaning that enterprises expect to have, and it is also a major positive for the rapid production and sales of products. As the speed of the innovation approval process continues to accelerate, this will certainly break the stalemate in the same approval of medical device innovation products and common products, and benefit domestic leading enterprises.
Source: Medical Device Innovation Network
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