The approval time is shortened by nearly three months! 21 innovative medical devices were approved to go on the market last year

Zhao Yang, a correspondent with Hu Fang, a reporter from China food and drug network, reported that the navigation and positioning system, positron emission tomography and magnetic resonance imaging system for neurosurgery In 2018, the national drug regulatory authority approved the listing of 21 innovative products with strong innovation, high technology content and urgent clinical needs, which filled in the gaps in related fields and better met the health needs of the people In recent years, the examination and approval time has been shortened by 83 days In recent years, the State Drug Administration has implemented the opinions of the State Council on the reform of the examination and approval system of medical devices and the opinions of the State Office of the CPC Central Committee on deepening the reform of the examination and approval system and encouraging the innovation of medical devices to further promote the reform of the examination and approval system of medical devices and accelerate the innovation and development of medical devices Since the special approval procedure for innovative medical devices was released in February 2014, as of December 31, 2018, 197 products have entered the special review channel for innovative medical devices, and 54 innovative products have been approved for listing The review and approval time of innovative products is 83 days shorter than that of the other three types of first registered products, which speeds up the pace of marketing of innovative products In terms of the location of approved products, the number of innovative medical devices in major industrial provinces ranks top, respectively 18 in Beijing, 10 in Guangdong, 10 in Shanghai and 8 in Jiangsu According to the types of approved products, there are 13 in vitro diagnostic reagents, 9 diagnostic equipment and 22 implantable medical devices Among the first products with significant advantages of passive implantable medical devices, foldable artificial vitreous balloon is worth mentioning The product is composed of balloon, drainage tube and drainage valve It is made of medical silicone rubber material It is suitable for patients with serious retinal detachment who can not be treated with the existing vitreous substitute This product is an innovative product independently developed by China and is the first in the world The product can be filled in the eye for a long time, which solves the problems that the vitreous substitute can not stay in the eye for a long time, can not press the retina for a long time or needs repeated operation, etc., so as to avoid the removal of the eyeball and the implantation of the artificial eye seat Among the active implantable products, "implantable vagal stimulation pulse generator kit" and "implantable vagal stimulation electrode wire kit" are the first domestic products of vagal stimulation in the treatment of epilepsy The "implanted vagal stimulation pulse generator kit" consists of a pulse generator, a test resistor, a torque screwdriver and a control magnet The "implanted vagal stimulation electrode lead kit" consists of electrode, tunnelling tool (including puncture tool and sleeve) and fixing clamp The combination of the above two products can control the seizure of patients with intractable epilepsy who can not be effectively controlled by drugs Among the diagnostic products, "positron emission tomography and magnetic resonance imaging system" has significant advantages over other imaging methods The product includes pet (positron emission tomography) and MR (magnetic resonance) It realizes the integration of PET imaging and MR imaging It can synchronously and equivalently collect physiological, anatomical and biochemical metabolism information, and register and fuse these information PET / MR imaging combines the advantages of pet and MR imaging modes, with the advantages of multimodality, multi contrast, high resolution, high sensitivity and low radiation dose Clinical practice has proved its clear role in the diagnosis of head and neck tumors, abdominal tumors, degenerative neuropathy, systemic lymphoma and other diseases In the treatment equipment, orthopedic operation navigation and positioning system adopts 6-DOF mechanical arm, compatible with 2D and 3D medical image and other patented technologies, and all performance indexes reach the international level of similar products The system consists of mainframe, mechanical arm, operation planning and control software, optical tracking system, main control trolley and navigation positioning kit, which is used to complete the positioning of surgical instruments or implants assisted by mechanical arm in spine surgery and trauma orthopedic open or percutaneous surgery It can effectively ensure the accuracy of screw placement, shorten the operation time, reduce the X-ray radiation injury and reduce the patient's injury List of innovative medical devices approved by national drug regulatory authorities: