On January 13, according to the State Drug Administration, after review, the application for registration of the innovative product “iliac artery bifurcation stent system” produced by Lifetech (Shenzhen) Co., Ltd. was approved for the treatment of abdominal iliac aneurysms or common iliac artery tumor.

On the same day, the State  Drug Administration released the “State  Drug Administration Holds Innovative Medical Device Achievement Report Video Conference”, showing that since 2014, the State Drug Administration set up a rapid approval channel for innovative medical devices, and a total of 100 innovative medical devices have been approved for listing.

These innovative medical devices are close to or reach the international advanced level and have significant clinical application value. Some innovative medical devices fill the gaps in related fields in China, better meet the people’s demand for high-quality and high-level medical devices, and effectively guarantee the promotion of the people. The lives of the people are healthy.

Since 2014, China has actively created a policy atmosphere that encourages innovation and promoted the innovation-driven development track of medical devices.

On February 7, 2014, the former State  Drug Administration issued the “Special Approval Procedure for Innovative Medical Devices (Trial)”, which came into effect on March 1, 2014, which opened up the boom in China’s innovative medical devices prelude.

As of November 2018, the State  Drug Administration revised and issued the “Special Review Procedures for Innovative Medical Devices”, which improved the applicable conditions, refined the application process, improved the effectiveness of innovation review, improved the review method and notification form, and clarified the Priority is given to changes in the licensing of innovative medical devices.

According to the China  Drug Network, since the opening of the “green channel” for innovative medical devices in 2014, as of the end of December 2020, 1471 products have applied to enter the innovation channel, and 292 products have been included in the channel as innovative medical devices, accounting for approximately all About 20% of applied projects. Up to now, a total of 100 innovative medical devices have been approved for marketing.

In recent years, the number of innovative medical devices approved has basically increased year by year. 1 innovative device was approved in 2014, 9 in 2015, 11 in 2016, 12 in 2017, 21 in 2018, and approval in 2019 19, 26 approved in 2020.

Among the 100 products, 96 are domestic products, involving 78 medical device companies in 14 provinces, autonomous regions and municipalities directly under the Central Government, accounting for 96% of all products, and 4 are imported products, involving 4 companies in two countries. In terms of approved product locations, major industrial provinces ranked high in the number of innovative medical devices, with 25 in Beijing, 19 in Shanghai, 17 in Guangdong, and 14 in Jiangsu. In terms of product characteristics, there are 43 active devices, 37 passive devices, and 20 in vitro diagnostic reagents and equipment.

Researchers from the School of Medical Devices and Food, University of Shanghai for Science and Technology published an article analysis in “Progress in Biomedical Engineering”. China’s medical device industry is still in the early stage of innovative development. Medical device products have rapid iterations, short R&D cycles and original The characteristics of slower technology update are mainly aimed at improved innovation, and more attention is paid to the commercialization and clinicalization of mature technologies.

In view of China’s current development trend, gradually replacing imports will be the main theme of the industry’s development in the next decade. Looking back on the successful experience in the field of import substitution, China will realize import substitution in more subdivided fields in the future.

Independent innovation, platform-based layout, and extension to the downstream industrial chain are the development logic of China’s equipment companies other than import substitution.

At the same time, Chinahas formed a number of specialized industrial clusters in the supporting industrial chain, creating favorable conditions for cost control and expansion of production scale. Based on the huge consumer groups and the support of relevant departments, the development of China’s medical device market is extremely broad.

From imitation to imitation, and then to creation, China’s medical device industry is constantly upgrading, and the huge space for industry development has become a battleground for medical companies. The continuous maturity of the capital market provides a strong guarantee for the production of medical devices. A good external environment and years of talent accumulation have helped us to start a new wave of medical device innovation in China.

(sourceinternet, reference only)