Favorable new regulations issued, medical devices usher in another opportunity

01 Intensive release of favorable policies for healthcare security and approval: Medical devices usher in a new window period for development

Recently, multiple national and local departments have successively released favorable policies for medical devices, providing strong support in various aspects such as research and development, approval, hospital admission, payment, and going global.
On December 10th, Xinhua News Agency released an article titled “Promoting the Development of Innovative Drugs and Medical Devices through Efficient and Strict Supervision – An Interview with Li Li, Director of the National Medical Products Administration”.
Li Li mentioned that since the “14th Five-Year Plan” period, 220 innovative drugs and 282 innovative medical devices have been approved for marketing, which are 6.2 times and 3.1 times those of the “13th Five-Year Plan” period respectively.During the “15th Five-Year Plan” period, drug regulatory authorities will adhere to the combination of an effective market and an effective government, respect the dominant position of pharmaceutical enterprises in innovation, support enterprises in strengthening the layout of research and development of innovative drugs and medical devices, and help enterprises transform new medical technologies into new productive forces,deepen and expand the achievements of reform pilots such as clinical trial review and approval, supplementary application review and approval procedures, and segmented production. For key varieties, implement the approach of “early involvement, one enterprise, one policy, full-process guidance, and linkage between research and review”. Allocate review resources sufficiently to “global first-in-class” original products and domestic alternative products that break through “bottleneck” technologies, and enhance the high-quality development of the pharmaceutical industry through the optimization of regulatory policies.
Li Li mentioned that efforts will be made to accelerate the launch of innovative drugs and medical devices. The registration and inspection process will be optimized, the quantity of samples required for registration and inspection will be reduced, the inspection cycle will be shortened, enterprise costs will be lowered, and the time-to-market cycle for drugs and medical devices will be reduced. Efforts will be stepped up to improve systems related to intellectual property protection such as pharmaceutical experimental data protection, accelerate the transformation and application of original research results in pharmaceuticals and medical devices, and enhance the core competitiveness of China’s pharmaceutical industry.
In terms of healthcare security reform, multi-chain support is also provided, including payment, settlement, legislation, and catalog management.Recently, Zhang Ke, Director of the National Healthcare Security Administration, stated in an interview with Xinhua News Agency that during the “15th Five-Year Plan” period, the management of medical consumables and medical service items covered by healthcare security will be improved. Research will be conducted to formulate a national unified catalog of medical consumables and medical service items for inter-provincial remote medical treatment covered by healthcare security.
In terms of legislative guarantees, we will improve the healthcare security legal system and accelerate the legislative work of the “Healthcare Security Law”; at the same time, we will further deepen the reform of medical service prices. We will strengthen the collection, research and application of real-world data on pharmaceuticals, carry out summary and evaluation of the pilot reform of medical service prices, comprehensively summarize the experience of the pilot reform of medical service prices, and make full preparations for the full implementation of the reform of medical service prices. We will fully complete the formulation of project approval guidelines and the work of docking and implementation.
During the “15th Five-Year Plan” period, the National Healthcare Security Administration will promote the formation of a comprehensive security pattern where various security systems have clear boundaries, are complementary to each other, and have coordinated functions.

02 Beijing, Shanghai, and Guangzhou have successively released supportive policies to stimulate enthusiasm for medical device innovation

With the release of the “15th Five-Year Plan” proposal, the innovation path for the medical device industry over the next five years is gradually becoming clear.
The National “15th Five-Year Plan” proposals clearly put forward such initiatives as “supporting the development of innovative drugs and medical devices”, “strengthening original innovation and tackling key core technologies”, and “optimizing the environment conducive to original and disruptive innovation to produce more landmark original achievements”.
From the 14th Five-Year Plan’s “improving the rapid approval mechanism for medical devices” to the 15th Five-Year Plan’s proposals of “supporting the development of medical devices” and “optimizing medical insurance payment”, and from the acceleration of review and approval to support for hospital admission and commercialization, innovative medical devices will enter a period of faster volume growth in the next five years.
Recently, the Beijing Municipal Bureau of Economy and Information Technology, together with six departments including the Municipal Development and Reform Commission, Health Commission, and Drug Administration, issued the “Several Measures for Promoting the High-Quality Development of the Medical Device Industry in Beijing”.
Beijing has made it clear that eligible innovative medical device products will be promptly included in the “Zhongguancun Innovative Medical Device Product Catalog” and the “Beijing First Set of Major Technical Equipment Catalog”. Efforts will be intensified to promote these catalogs among medical institutions, product promotion conferences will be organized regularly, and the procedures and mechanisms for directly recommending products in the catalogs for admission to hospitals will be improved.
In terms of payment, for innovative projects that are currently incompatible with the national project approval guidelines, on the basis of ensuring clinical efficacy, medical institutions are supported to approve and pilot such projects through the “conditionally added” method.
First, support clinical research and development as well as registration and market launch, highlight the collaborative innovation between doctors and engineers, and accelerate product registration and market launch.Second, support the implementation, promotion and application of achievements, and support projects for promotion and application.
In addition to Beijing, Shanghai has recently issued the “Several Measures for Shanghai to Comprehensively Deepen the Reform of Drug and Medical Device Supervision and Promote the High-Quality Development of the Pharmaceutical Industry”. These measures aim to expand the scope of healthcare security coverage for medical service items and medical consumables, so as to include more innovative products. Shanghai is also exploring an efficient connection mechanism for “new and high-quality drugs and medical devices” from research and development to application, optimizing the admission process for new drugs that are irreplaceable for clinical emergency and critical care rescue, and gradually reducing the processing time from 30 working days to 15 working days.
In addition, Shanghai will improve the efficiency of registration and evaluation for Class II medical devices. For Class II medical devices with significant clinical value and strong innovation, applications for the innovative special review procedure are encouraged, with priority given to registration inspection, technical evaluation, and registration system verification; medical devices that are the first of their kind in the country or meet the conditions for priority approval shall be implemented by reference.
Guangzhou also released twelve measures to promote the application of innovative drugs and medical devices in October. After the release of the Guangzhou Innovative Drugs and Medical Devices Product Catalog, medical institutions must hold a working meeting of the Pharmacy Administration and Drug Therapy Committee or the relevant committee for medical devices within one month. They shall hold relevant working meetings no less than 4 times a year, and the topics of the meetings must include discussions on the admission of innovative drugs and innovative medical devices. They shall promptly include the innovative drugs and medical devices in the list of drugs or medical devices used by the medical institutions as needed, achieve the goal of “equipping all that should be equipped”, and give priority to their selection.
Guangzhou has also proposed a nationwide pioneering approach. Relying on a refined management platform to dynamically monitor the application of innovative drugs and medical devices, relevant medical institutions are required to submit a written report explaining the reasons for not including products from Guangzhou’s innovative drugs and medical devices catalog in their in-hospital catalog, or for not purchasing and using varieties that have been approved through discussions within 2 months. At the same time, it also eases restrictions on hospitals in terms of payment.The notice clearly states that expenses related to innovative drugs and medical devices are not included in the performance monitoring of public medical institutions, such as the average outpatient expense and the average in-hospital drug expense. Medical institutions shall not affect the rational use of innovative drugs and medical devices on the grounds of the number of drugs in the institution’s medication list, the proportion of drug expenses, the proportion of consumable expenses, or restrictions on monthly drug usage.
The favorable policies for medical devices successively issued in Beijing, Shanghai, and Guangzhou also indicate the future of the industry under the nationwide whole-industry-chain collaborative pattern. The industrial cluster effects in the Beijing-Tianjin-Hebei region, the Yangtze River Delta, and the Greater Bay Area will be further enhanced, and the vitality and innovation enthusiasm of the medical device market will be fully released.
According to the data analysis by Frost & Sullivan, from 2020 to 2024, the overall market size of China’s medical devices has increased from 729.8 billion yuan to 941.7 billion yuan, with a CAGR of 6.6%. It is expected that by 2035, the overall market size of China’s medical devices will reach 1,813.4 billion yuan.
Driven by both the national strategic guidance and the release of local vitality, China’s medical device industry is transforming from “scale expansion” to “quality improvement”. New breakthroughs are expected in some high-end fields that have long been “bottlenecked”, and the industry boundaries will be further expanded.
China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com
Source：Saibailan Device
Translated & edited：Bradyknown