New 2017 CFDA Approved Implant Instrumentation Analysis

Medical network February 27 hearing intervention implant medical devices including cardiovascular stents, drug-eluting balloons, orthopedic implants, biological valves and other medical high-value supplies, is rapidly developing in the field of medical devices, but also a huge market space category.

According to the 2016 Medical Device Registration Report issued by the CFDA, the number of approved applications for implantable materials and prosthetic devices in the third category of medical devices and imported medical devices registered in China has increased from the second Bit up to the first place.

In 2017, the CFDA strengthened the supervision and administration of the registration of medical devices and continued to deepen the review and approval system of medical devices.In this paper, based on the registration information of medical devices disclosed by the CFDA, CFDA (6877) and the implant materials Artificial Organs (6846) These two sub-categories make simple statistics on products approved in 2017.

As the interventional instruments, especially cardiovascular interventional devices higher technical barriers, the domestic R & D and production of stents, balloons and other products, especially drug stents, biodegradable stent and drug balloon and other high-end devices enterprise The number of implants is very limited. Devices such as orthopedic implants are relatively mature and have relatively low technical barriers. Therefore, the number of approved implants is much higher than that of interventional devices.

Implantation instruments approved the number of contrast

In the two years since "Made in China 2025", the localization of medical devices has obviously accelerated and the domestic medical devices are rapidly emerging. In May 2017, the State Council held a standing meeting to promote the "Made in China 2025" in-depth implementation and made it clearer The development of imaging equipment, high-value medical supplies, such as localization of the six medical devices line.

In 2016, the registration numbers of domestic and imported implants and prostheses were 360: 509, up from 355: 257 in 2017, with a noticeable decrease in the approval of imported equipment and a reflection of The approval of the state from the medical device review and approval level based on the localization of medical equipment support.

Among orthopedic implants, among the traumatic products such as bone fracture plates and intramedullary nails, the spine products such as artificial hip joints, knee joint and other joint products, and intervertebral fusion devices are the three major categories. In addition to this, There are other materials such as bone cement, bio-ceramics.

In 2017 the newly approved orthopedic implants, trauma accounted for nearly half of the spine and joint class equal shares.

In implantable biofilms, there are three domestic creatures heart Valves were approved, of which two were innovative medical devices approved through the special approval channel, namely the 'Percutaneous Interventional Artificial Heart Valve System' manufactured by Hangzhou Qiming Medical Devices Co., Ltd. and the Suzhou Jingcheng Medical Technology Co., Ltd. Innovative product 'Interventional Artificial Heart Valve'.

Among the cardiovascular interventional devices, all the drug-eluting stents approved in 2017 are imported. There are no products approved for biodegradable stents in China. Among the domestic devices, only two drug-eluting stents and two aortic stents are obtained Batch, of which two medical approved Wei Jianwei rapamycin coated stent system, Hua Mai Tyco's abdominal aortic stent graft system is included in the innovation medical instruments Special approval list and successfully approved.In addition, due to the urgent clinical needs of Euiyi drug-eluting balloon, and in our country has not been approved for registration of different varieties of products, it was included in the list of priority medical devices approved and successfully approved from the public to The final approval, with seven and a half months.

In addition to the drug-eluting balloon of Enemy Bio, among the 9 products included in the preferential approval process for medical devices, which was officially put into operation on January 1, 2017, there are also interventional devices including Hua Mai Tycoon in the national key research and development programs Thoracic aortic stent graft system.

In 2017, CFDA announced a list of 10 approved medical device special approvals, including 64 innovative medical devices, of which 18 were cardiovascular intervention devices.

2017 Cardiovascular products specifically approved for innovative medical devices