Innovative Medical Devices drive on the ＂Green Channel＂

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Time：2020-08-17Click：

Source: China In Vitro Diagnostic Network

As of March 1 this year, the Special Approval Procedures for Innovative Medical Devices (Trial) issued by the State Food and Drug Administration has been implemented for three years. In the past three years, every product approved by the "green channel" through the special approval of innovative medical devices will arouse strong attention in the industry. While people are lamenting the innovation of medical technology, they can't help but ask: why can these products enter the special approval "green channel"? How representative of their innovations are they? What benefits can it bring to people's healthy life?

"Before the reform and opening up, China's medical device research and development has always followed foreign countries. In the past 30 years, original medical devices have appeared in China. Although originality is very difficult, the future of China's medical device industry must be driven by originality." Professor Wang Zhibiao, dean of the School of Biomedical Engineering, Chongqing Medical University, said forcefully.

High-end medical imaging equipment integrates the cutting-edge technology of medical devices. It is noteworthy that in May 2015, uMR770 magnetic resonance imaging (MRI) system produced by Shanghai Lianying Medical Technology Co., Ltd. was approved to be listed. This is the first domestic 3.0 Tesla (T) MRI system approved for registration in China. In November 2015, the digital mammography equipment produced by Kening (Tianjin) Medical Equipment Co., Ltd. was registered, becoming the first real three-dimensional breast imaging system approved in China. In October 2016, the positron emission and X-ray computed tomography Unit (PET-CT) manufactured by Mingfeng Medical System Co., Ltd. was approved for market. Combining CT and PET, the product provides registration and fusion of physiological and anatomical information, representing the most cutting-edge technology in modern medical imaging equipment.

"Lianhe Imaging is very lucky that our first domestically developed 3.0T Mr System with all the core components is the first pilot product in the trial of a special approval process for innovative medical devices. Reviewers step in ahead of time, do field research on the product, understand the development process, provide guidance and communication, and identify risks ahead of time." Wang Shumei, vice President of The quality management and regulatory affairs department of Shanghai Lianying.

"The advent of domestic high-end medical imaging equipment has broken the import monopoly and forced import manufacturers to lower prices. "This will undoubtedly lead to further reductions in healthcare costs and access to better healthcare resources for more patients." Industry experts say.

Precision and effort, benefit the health needs of the people

With the change of people's disease spectrum, the aggravation of population aging, the increase of the incidence of chronic diseases such as cardiovascular disease and diabetes, the demand for medical equipment is also changing. Can the review and approval process accurately grasp the clinical needs to enable innovative products to serve healthcare earlier?

Brain pacemaker, also known as "deep brain stimulation system" (DBS), has become one of the main treatment methods for Parkinson's disease due to its advantages of minimally invasive and adjustable. But until now DBS's core technology has been dominated by foreign firms. In June 2015, suzhou Jingyu Medical Equipment Co., LTD., after years of research and development, approved the dual-channel implanted deep brain stimulation system, which broke the import monopoly.

In May 2016, Beijing Pinchi Medical Equipment Co., Ltd. produced implantable vagus nerve stimulation pulse generator kit and implantable vagus nerve stimulation electrode wire kit were approved for market. This is the first domestic medical device for the treatment of epilepsy by vagal nerve stimulation.

"There are many patients with epilepsy in China, so it is urgent to popularize vagus nerve stimulation therapy. However, imported equipment is expensive, and foreign enterprises focus on market sales and lack of technical support in the later stage. After the launch of domestic equipment, due to stable performance, the price is significantly reduced, and we made great efforts to establish after-sales professional support, so it can be quickly promoted. Product chi medical general manager Hao Hongwei told reporters.

"Precision medicine is the 'hot word' in medicine. The foundation of precision medicine is accurate diagnosis." Bo Ao biological group Co. LTD. Vice President Zhang Chuan told reporters.

In April 2015 and February 2016, boao Biological Group's thermostatic amplification microfluidic chip nucleic acid analyzer and respiratory pathogenic bacteria nucleic acid detection kit (thermostatic amplification chip method) were approved to be listed after passing the application review of "Special Approval Procedure for Innovative Medical Devices (Trial)" respectively.

According to Zhang, the two innovations are not only domestic innovations, but also international ones. They meet the rapid and precise demands of modern medicine. Among them, the respiratory pathogenic bacteria nucleic acid detection kit can qualitatively detect 8 clinically common lower respiratory tract pathogenic bacteria in sputum, which can greatly improve the detection efficiency and avoid delayed treatment and misuse of antibacterial drugs. If mycoplasma infection is confirmed and the patient is treated with erythromycin, the problem can be solved for a small amount of money.

The incidence of atrial fibrillation in the elderly is high in China, and the incidence of atrial fibrillation in people over 75 years old is as high as 10%. In May 2016, the cold saline perfusion radiofrequency ablation catheter of Shanghai Minimally Invasive Electrophysiological Medical Technology Co., Ltd. was approved to be marketed. The system is equipped with a magnetic field positioning sensor, which is used in conjunction with another innovative 3d cardiac electrophysiological mapping system to help doctors observe the spatial position and movement direction of the catheter tip in the cardiac cavity in real time, locate the lesions through the three-dimensional anatomical configuration and navigation functions of the cardiac cavity, and perform accurate radiofrequency ablation therapy.

"In the absence of such a device, the surgeon performs ablation based on personal experience and the recurrence rate is higher. Using the new system can improve the accuracy of treatment, reduce recurrence rate, shorten the time of operation, and thus reduce the amount of X-ray exposure of doctors. The system competes directly with Johnson & Johnson's similar products at a much lower price." Minimally invasive medical senior vice President Xu Yimin told reporters.

In December 2016, the pulmonary artery valve of Beijing Bairen Medical Technology Co., Ltd. was approved to be listed, filling the gap in the field of high-end artificial biological heart valve in China, which will bring good news to the majority of children with complex congenital heart disease.

We will support innovation and accelerate the reform of examination and approval

Since the implementation of special Examination and Approval Procedure for Innovative Medical Devices (Trial), in 2014, 2015 and 2016, THE General Administration of China has received 138, 157 and 193 special examination and approval applications for innovative medical devices respectively, totaling 488. By the end of 2016, 461 inspections had been completed, of which 89 products had entered the "green channel" for special approval, and 20 had been marketed. The number of applications for special approval of innovative medical devices has been increasing year by year, indicating that the policy has been widely recognized by the industry.

From on behalf of the cutting-edge technology of high-end large medical imaging equipment, to clinical demand great intraocular lens products, such as national administration in the premise of ensuring the product is safe and effective, with product core technology invention patent or patent application for invention is published by the administrative department for patent under the State Council, at the international leading level technology, has significant clinical value of innovative products to give priority to handle, average review time is greatly shortened, effectively promoted the innovation of medical apparatus and instruments market, the process has led many innovative products can bring benefits to clinical doctors and the patients as early as possible. In addition, while promoting the technical level of domestic medical devices, foreign enterprises are also encouraged to introduce more advanced products to China. New products from medtronic, Abbott, Boston Scientific and other multinational companies are among the products that have passed special approval applications for innovative medical devices.