Development and Upgrading of Medical Devices Have Been Accelerated In Many Cities

Recent years, China has focused on the actual development of the medical device industry as well as the public demand for medical devices, and is continuously issuing favorable policies to promote the healthy and orderly development of the medical device industry.

At present, the domestic medical device industry has ushered in a broader space for development. At the same time, a large number of domestic innovative medical device products have started to emerge, and many medical behaviours have been changed by the emergence of new technologies and new products. In addition, a large number of medical device companies have also seen favourable performance.

It is worth mentioning that, against the backdrop of the promising development of the medical device industry, a series of favorable programs and documents have been issued around the world to further promote the high-quality development of the medical device industry.

For example, recently, the Guangdong Provincial Drug Administration issued "Several Measures on Optimizing the Review and Approval of Class II Medical Device Registration" (hereinafter referred to as "Several Measures") to comprehensively optimize and speed up the review and approval of medical device registration.

20 specific measures cover optimizing the review and approval process, supporting innovative priority projects, improving the efficiency of testing and inspection, and enhancing the level of licensing services, etc., in an effort to address the bottlenecks that currently restrict the development of Guangdong's medical device industry. The measures are aimed at solving the bottlenecks that currently limit the development of the medical device industry in Guangdong.

Among them, the "Several Measures" specify that the technical review time frame for registration of Class II medical devices in the province will be speeded up by more than 50% on average compared to the statutory time frame, and the administrative approval time frame will be speeded up by 50%. At the same time, the establishment of fast track in inspection and testing, technical review, to maximize the efficiency of the process.

It is worth mentioning that in February this year, Guangdong Province issued the Implementation Plan for Promoting the Quality Development of Medical Device Industry in Guangdong Province.

The Programme clearly mentions that it will strive to achieve an average annual compound growth rate of 20% or more in the business income of the medical device manufacturing industry by 2025, with the annual business income of the medical device manufacturing industry above the scale reaching 250 billion yuan; 50 national registration certificates for innovative medical devices will be approved; 35 enterprises will be listed in the capital market, 2 demonstration enterprises with a market value of over 100 billion yuan will be listed.

The number of enterprises listed in the capital market will reach 35, and the market value of listed enterprises will exceed 100 billion yuan, and there will be 3-5 enterprises with annual revenue of more than 10 billion yuan and 5-8 enterprises with revenue of more than 5 billion yuan. The industry believes that the overall speeding up of the review and approval will further boost the high-quality development of Guangdong's medical device industry.

Prior to this, the Shandong Provincial Drug Administration, the Provincial Department of Science and Technology, the Provincial Department of Industry and Information Technology, the Provincial Health Care Commission and the Provincial Medical Insurance Bureau jointly issued "Sixteen Measures on Promoting the High-Quality Development of the Medical Device Industry" (hereinafter referred to as "Measures").

The Measures consist of 16 articles, covering "increasing support for medical device innovation", "guiding and supporting the development of medical device clusters", "comprehensively optimizing approval and vetting services", and "effectively safeguarding the quality and safety of medical devices". The four parts of the Measures are "effectively safeguarding the quality and safety of medical devices".

Specifically, in order to speed up the high-quality development of the medical device industry, the Shandong Provincial Drug Administration based on its own responsibilities, in the optimization of the review mechanism, to enhance the effectiveness of the approval services and other aspects of the study proposed a number of measures, such as: to speed up the ability to improve testing services, compress the review and approval time frame, the implementation of similar products centralized review, optimize the inspection and verification mechanism, streamline the approval process.

In addition, at the beginning of this year, the Zhejiang Provincial Drug Administration and the Provincial Department of Economy and Information Technology also jointly issued the Notice on Comprehensively Enhancing the Supervisory Capability of Medical Devices to Promote the High-Quality Development of the Industry (hereinafter referred to as the Notice) to promote the high-quality development of the medical device industry.

In the Notice, the development target of the medical device industry in Zhejiang Province is to emerge a number of leading enterprises with strong independent innovation capability by 2025, form a number of medical device parks with obvious advantages of industrial clustering, and basically form a whole-chain innovation system with the combination of industry, academia, research and application, upstream, midstream and downstream convergence, and synergy between large, medium and small enterprises.

The output value of the medical device manufacturing industry in the province reached 100 billion yuan.

From the overall perspective of the medical device industry development programs introduced around the world, in the long term future, promoting the innovation and upgrading of the medical device industry and high-quality development will be an important task around the world.

In this context, the industry expects that China's medical device industry will usher in a golden period of development. However, it is worth noting that the safety of medical devices is closely related to the health of the people. In order to strengthen the supervision and management of medical device production, regulate medical device production activities, and ensure the safety and effectiveness of medical devices, the state has also been strengthening the supervision of this field in recent years.

For example, at the end of March, the State Administration of Market Supervision released the revised "Supervision and Administration of Medical Device Production" and "Supervision and Administration of Medical Device Operation", which made relevant provisions for engaging in medical device production activities and production quality management, and further increased the penalties for illegal acts of enterprises.

In this regard, industry analysts believe that the future of the medical device industry will usher in stricter regulation while moving into a new phase of transformation and upgrading.