Orderly development. Beijing's first two types of innovative medical devices are quickly approved for sale

Medical Network June 28 June 27, the reporter learned from the Beijing Food and Drug Administration, medical devices ' lower limbs walking machine training device ' products in the June 26 access to the "Medical Device registration certificate", was approved on the market.

This is the first new type of innovative medical device in Beijing, which was quickly approved by green channels, and its listing will bring the gospel to many patients with lower limb motor dysfunction caused by spinal cord injury. In China, there are as many as millions of patients with spinal cord injuries due to trauma or other neurological diseases that cause injury to the lower limbs.

Due to medical resources and the existing technical limitations of rehabilitation treatment, many patients can not be fully cured, walking ability to decline, so that the patient's daily life ability has been greatly affected. Beijing Food and Drug Administration officials said the approved ' leg walking machine-assisted training device ' is mainly used in patients with lower limb motor dysfunction caused by spinal cord injury to walk rehabilitation training.

By wearing the device, the use of auxiliary devices such as crutches, Walker, such as natural walking gait, the real way of walking, supporting and driving patients to carry out walking rehabilitation training, this real humanoid walking posture to accelerate the recovery of lower limb motor function.

The official said that in order to encourage the Beijing Medical Device Innovation research and development and scientific and technological achievements transformation, optimize the business environment, promote the industrial transformation and upgrade, the Bureau revised the implementation of the Beijing medical Device Rapid review and approval method for innovative and priority medical devices to achieve green channel. ' There are 4 types of medical device products applicable to rapid approval conditions, ' the person in charge, one is the national and Beijing related scientific research projects, involving the core technology inventions have been patented or open; Second, the city's first, product technology leading domestic, with significant clinical application value, involving the core technology inventions have been patented or open; Third, Chichong cultivation project, Beijing biological Medicine Industrial Crossing Development Project (G20) and other Beijing key supporting enterprises production, the core technology involved has been patented or open;

Four is included in the national or Beijing major science and technology special, key research and development program products. The person in charge said, ' Leg Walking machine auxiliary Training device ' is the first two kinds of innovation approved by Beijing to meet the fast approval conditions Medical equipment

, the bureau in addition to the reduction of product registration fees, also in the examination and approval of various links dedicated services, the full follow-up, from the registration to the approval of registration time than the statutory working hours shortened by more than half, greatly accelerated the pace of innovation products listed. The official pointed out that, as of now, Beijing has 224 medical device products into the original national food Drug

The General administration of management Innovation product review approval channel, which completely degradable polymer basic drugs (rapamycin)-eluting stent system, noninvasive blood glucose meter, surgical robot positioning system, etc. 36 products approved by the original state administration of Food and Drug Administration innovation product approval, the number ranked first in the country. Beijing Food and Drug Administration deputy director Lianghong said that in the future will continue to encourage support for medical device industry innovation and development of clinical needs, children or people with disabilities unique and multiple disease use, diagnosis or treatment of rare diseases and other medical devices to speed up the landing of products. At the same time, increase the Enterprise Service dynamics, optimize the business environment, and strengthen the quality supervision after the product is listed, ensure the safety of medical device use and guarantee the related industry Health