In order to ensure safe and effective medical devices, encourage research and innovation in medical devices, promote the popularization and application of new medical devices and technology, promote the development of the medical device industry, February 7, 2014, the State Food and drug administration organizations to develop a "special innovative medical device approval process (Trial)". Since the implementation of the program, how about the approval and approval in all parts of the country?
The author summarized the "product and business innovation of medical examination and approval procedures to enter the program" since the release of the country, can be seen from the following summary table, special innovative medical device approval showing the following characteristics:
A class of medical devices, biotechnology, gene.
From entering innovative medical devices special approval process product categories, biological, genetic, innovative medical devices by management favorite. Such as the SMN1 gene for Shanghai wuseshi Medicine Research Co Ltd exon deletion detection kit; constant temperature for CapitalBio limited company of group of nucleic acid amplification microfluidic chip analyzer; Abbott Vascular for the whole absorption type biological stent system; MTHFR C677T gene detection reagent box for Xi'an gold magnetic nano biotechnology Co Ltd; bor Cheng (Beijing) box colorectal cancer methylation gene detection reagent for the application of science and Technology Co. Ltd; Guangzhou you have to apply for the Qing biotechnology limited company's biological artificial cornea; application of Qingdao Yu Ming Biological Technology Co. Ltd. the tissue-engineered human corneal endothelium. These products accounted for the majority of all over the batch of innovative medical devices 17 products, accounting for 41.2%.
Visible, selection of medical innovation point, conform to the trend of technological development, meet the demand of social consumption, master core technology and intellectual property, become smoothly through the four tips of innovative medical devices for approval, but also to establish basic competition strategy for an invincible position from the source!
Two, compared with 2014, 2015 approval rate accelerated
Since the implementation of the program, a total of 17 products have been adopted. Among them, in 2014 the total approval of 11 items. In 2015 and March, 6 items were approved by innovative medical devices, indicating that the country's approval rate for innovative medical devices has accelerated. This caters to the expectation of the industry and enterprises, and is a big positive for the rapid listing, production and sale of products.
Three, innovative medical equipment sources mainly in coastal areas
From the summary table can be seen, the application of innovation for approval of medical devices manufacturers are mainly distributed in Beijing, Tianjin - Bohai Economic Zone in the Yangtze River Delta economic zone; Shanghai, Suzhou; the Pearl River Delta Economic Zone of Shenzhen, Dongguan. Among them, the inland provinces through innovative medical device approval of manufacturers rarely, only Xi'an and Wuhan each have one. This accords with the present situation of China's economic development, economic development, technological progress has become the main source of China's coastal areas of the development of innovative medical devices.
Innovative medical device product approval summary sheet
Serial number, product name, application year
1 、 ablation catheter and nerve stimulation radio frequency ablation instrument with accurate mapping renal sympathetic nerve function, Suzhou Xin Mai medical instruments Co., Ltd., 2015
2 constant temperature nucleic acid amplification microfluidic chip analyzer Boao biological Group Co. Ltd.
3 children intelligent control gastric lavage machine, Tianjin interbank Technology Development Co., Ltd.
4 drug eluting peripheral balloon dilating catheter, Beijing first prize Medical Technology Co., Ltd.
5 SMN1 gene exon deletion detection kit (fluorescence quantitative PCR) Shanghai wuseshi Medical Research Co Ltd
6 complete absorption biological vascular stent system Abbott Vascular
7 MTHFR C677T gene detection kit (PCR- gold magnetic particle chromatography) Xi'an gold magnetic nano Biological Technology Co., Ltd., 2014
8 acellular corneal stroma Shenzhen Neil cornea Engineering Co. Ltd.
9 absorbable drugs coronary stent systems, first health technology (Shenzhen) Co., Ltd.
10 pulmonary valved conduit Wuhan Tianshan Medical Technology Co Ltd
11 cone beam CT (Corning cone beam breast breast imaging system) Corning (Tianjin) medical equipment Co., Ltd.
12 colorectal cancer methylation gene detection kit (PCR fluorescent probe), Boer (Beijing) Technology Co., Ltd.
13 biodegradable magnesium bone screws, Dongguan Yi an Polytron Technologies Inc
14 sternum plate Changzhou Hua Sen Medical Instrument Co., Ltd.
15 tissue engineering human corneal endothelial Qingdao Yuming Biological Technology Co., Ltd.
16 biological type cornea Guangzhou excellent biological science and Technology Co Ltd
17 absorbable dura mater sealing medical glue, Shandong mosaic Pharmaceutical Technology Co., Ltd.
In short, the implementation of the "program" effect from the above analysis can be summarized. The program complies with the requirements of the state to encourage the research and innovation of medical devices, and is conducive to play the role of market mechanism, and further promote the popularization and application of new medical equipment technology. For innovative medical devices, according to priority registration, inspection, technical review, registration approval principle, to maximize the speed of innovation and development of medical equipment in china.
