The reform of the review and approval system has promoted the acceleration of the development of innovative medical devices by mechanical enterprises

In recent years, with the deepening of the reform of the medical device review and approval system, the Medical Device Technical Evaluation Center of the State Food and Drug Administration (hereinafter referred to as the Device Review Center) aims to improve the quality efficiency and scientificity of the review, vigorously build a modern review system, strengthen the review capacity building, and carry out regulatory scientific research, which is laying a solid foundation
for encouraging medical device innovation.
It is worth noting that with the help of a series of policies to encourage medical device innovation and promote the high-quality development of the industry, the domestic medical innovation industry has begun to accelerate its development
.
By the end of 2021, 134 device products had been approved for marketing, and 44 projects (49 products)
had been approved for marketing in accordance with the priority approval process.
Since the beginning of this year, medical device companies have also made
continuous progress in innovation.
On November 10, the National Medical Products Administration released a dynamic display that the innovative medical device "left atrial appendage occluder system" produced by Hangzhou Denuo Electrophysiology Medical Technology Co.
, Ltd.
was approved
.
The left atrial appendage occluder system consists of a left atrial appendage occluder and a conveyor, in which the left atrial appendage occluder is connected by a sealing disc and an anchor disc
.
The conveyor consists of
a conveying sheath, spreader, loader, conveying cable and hemostatic valve.
The design of the sealing disc and anchor disc of the product adopts an innovative patented design, which makes full use of the adaptability of the nitinol braided structure, which can meet the clinical needs
for the closure of different forms of left atrial appendage to a certain extent.
According to reports, the product is suitable for patients
with non-valvular atrial fibrillation who are at risk of stroke and long-term oral anticoagulation therapy is contraindicated.
On October 31, Bo Medical announced on the Hong Kong Stock Exchange that the company's innovative product "Haoquan ™" single-use endoscope atomized microcatheter in the field of drug and device integration was officially approved for marketing
by the Zhejiang Provincial Drug Administration.
It is reported that the product has a number of patented technologies, a wide range of indications, can be adapted to a variety of drugs, and opens up a wide range of drug and device combination application scenarios
in the field of lung disease treatment.
It is used in conjunction with an endoscope to accurately reach the lesion under the guidance of a navigation system for irrigation, spraying or contrast.

In addition, Dirui Medical announced that it has obtained 1 "Medical Device Change Registration (Filing) Document" issued by the State Medical Products Administration, 41 "Medical Device Change Registration (Filing) Documents" and 7 "Medical Device Registration Certificates"
issued by the Jilin Provincial Drug Administration.
The change of registered products is mainly the addition of new applicable models to chemiluminescence immunoassay products; The first registered products involved biochemical analysis and coagulation analysis
.
It is worth mentioning that many device companies are still further accelerating the development of
innovative medical devices through financing.
For example, some time ago, many medical device companies such as Yaoshi Medical, Jizhi Medical, Yaguo Technology, and Parmother Medical successively announced the completion of financing
.
Among them, Jizhi Medical announced that its parent company, Beijing Litek Technology Co.
, Ltd.
, completed tens of millions of Series A financing, and the financing funds will focus on Jizhi Medical's digital rehabilitation robots and fitness products to promote the large-scale mass production and marketing layout and brand building
of its torque motor products.
The tens of millions of yuan of pre-A round of financing will be used for clinical trials and registration of its SLO (laser scanning ophthalmoscope) ultra-wide-angle confocal laser scanning ophthalmoscope products, as well as the research and development
of a variety of innovative ophthalmic disease diagnosis and screening equipment.
The new round of financing completed by Parmei Medical, which is tens of millions of dollars, will also be mainly used for continuous R&D investment, clinical trials, product registration and commercialization layout, including team building at home and abroad, and part of the funds will also be used to expand the company's operating and production capacity
.
Industry analysts believe that benefiting from the vigorous development of new domestic medical infrastructure and the continuous recovery of global conventional business, the domestic medical device industry will continue to develop, and related enterprises will also usher in more opportunities
through accelerated innovation.
However, it should be noted that in recent years, multinational medical device companies such as Medtronic, Philips, and General Electric have accelerated the localization of the Chinese market and are committed to promoting the localization of the whole product line
.
Therefore, the competition in the domestic innovative medical device market is expected to become more and more fierce
in the future.
Disclaimer: Under no circumstances does the information or opinions expressed herein constitute investment advice
to anyone.