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With frequent policy support, China's innovative medical devices ushered in a golden opportunity period

In recent years, the global medical device industry has accelerated its iteration and updating under the influence of the COVID-19. Both the market size and product functions are innovating and changing, constantly promoting the progress of the world. China attaches great importance to the innovative development of the medical device industry. In recent years, the domestic medical device industry has been advancing against the trend. The competent department has issued a number of policies to encourage domestic medical devices to accelerate innovation. Now, it is showing the strong resilience and innovative development advantages of the development of the medical device industry in China.

According to relevant industry reports, the operating revenue of China's medical device industry will reach about 1.156 trillion yuan in 2021, with a year-on-year growth of 11.24%. In 2022, the operating income of China's medical device industry will reach about 1.3 trillion yuan, with a growth rate of about 12%. From January to November 2022, China's total exports of medical devices reached 444.179 billion yuan, with a compound annual growth rate of 10.2%. The report also predicts that the compound growth rate of China's medical device industry will maintain a rapid expansion trend in the future.

In addition, the number of medical device products registered for the first time has grown steadily. In 2022, NMPA approved the first registration of 2172 medical device products of three categories, including 1818 domestic products and 354 imported ones. The provincial drug regulatory authorities approved a total of 13063 domestic Class II medical devices and 27117 Class I medical devices for registration in 2022. All kinds of data fully show that the heat of China's medical device industry continues to grow rapidly, and more and more Chinese enterprises with advanced technology, compliant operation and sound quality are gradually showing their international influence, which also promotes the expansion of the medical device market and the acceleration of domestic substitution. (Source of the above data: Southern Institute of Pharmaceutical Economics of the State Food and Drug Administration,


According to the reply of the State Health Insurance Administration, the State Food and Drug Administration issued the Special Approval Procedure for Innovative Medical Devices (for Trial Implementation) in 2014, and the Special Approval Procedure for Innovative Medical Devices was revised and improved in 2018 to set up special approval channels for medical devices with Chinese invention patents, domestic innovation in technology, international leading level, and significant clinical application value. Relevant departments shall give priority to the handling of innovative medical devices and strengthen communication with the applicant in accordance with the principles of early intervention, special person responsibility and whole-process guidance, without reducing the standards and procedures. In 2016, the State Food and Drug Administration issued the "Priority Approval Procedure for Medical Devices", which gave priority to the approval of medical devices included in the major national science and technology projects or key research and development plans, diagnosis or treatment of rare diseases, malignant tumors, diseases specific to the elderly and multiple diseases, medical devices for children, and clinical medical devices in urgent need, to promote the listing of such products as soon as possible.

The State Food and Drug Administration said that the above-mentioned two documents have played an important role in encouraging the innovation of the medical device industry and promoting the listing of medical devices urgently needed in clinic as soon as possible. Relevant qualified medical devices can apply for accelerated approval according to corresponding procedures.

In December 2021, the State Food and Drug Administration issued the "Fourteenth Five-Year Plan" for the Development of Medical Equipment Industry, which proposed to optimize the registration and review process of innovative medical equipment, and support medical equipment with invention patents and significant clinical application value to enter the special approval channel, giving priority to approval.



The "domestic substitution" of medical devices is also expected to accelerate. Since 2021, many provinces in China, including Zhejiang and Guangdong, have successively issued the latest version of the "Purchase List of Imported Medical Equipment". Even the equipment that has entered the purchase list needs reasonable reasons for purchase and cannot restrict domestic competition. Taking the Demonstration Opinion Publicity of Provincial Government Procurement Import Products List 2021-2022 (Medical and Health Equipment) released by Sichuan Provincial Government Procurement Network in April 2021 as an example, there are 59 kinds of medical equipment that can be imported, while in Guangdong Province, the number is 46.

For innovative medical devices, the policy level also leaves a certain market space beyond centralized purchase. In September 2022, in response to the NPC delegates, the State Drug Administration said that in the process of centralized purchase with volume, medical institutions should determine the purchase volume based on the historical use, combined with clinical use and medical technology progress. Because the clinical use of innovative medical devices is not yet mature and the amount of use is temporarily difficult to estimate, it is still difficult to implement the carrying method. In the process of centralized volume procurement, the National Health Insurance Bureau will reasonably determine the volume proportion according to the clinical use characteristics, market competition pattern and the number of selected enterprises, and set aside a certain market outside the centralized volume procurement to provide space for innovative products to expand the market.

The domestic medical device industry has blossomed from poverty to various fields, and has gradually broken through the core fields and key technologies. In 2023, it will move towards the innovation and high-end of domestic substitution.



Under the bonus of the approval policy, the approval speed of medical device products in China has increased. In 2022, the State Food and Drug Administration announced that 55 Class III medical devices were approved for marketing, and the number of approved innovative medical devices increased by 57.1% compared with 2021. Many products also achieved major technological breakthroughs worldwide, and better meet the needs of the people to use high-level medical devices.

In April 2022, the Bone-Shengyuan assisted knee joint robot was approved by the National Drug Administration (NMPA) for listing, filling the gap in the domestic robot assisted joint replacement market; The domestic medical imaging giant Xin Gaoyi, with its latest approved liquid helium-free series products, obtained the registration certificate of innovative medical devices issued by the State Food and Drug Administration in April 2022, which is the world's first 100% liquid helium-free superconducting magnetic resonance imaging system.

The proton therapy system of Shanghai Epqiang Particle Equipment Co., Ltd. was approved for listing in September 2022. It is the first domestic proton therapy system approved for listing in China, which is applicable to the treatment of systemic solid malignant tumors and some benign diseases. This product is a key support project of the key research and development plan of the Ministry of Science and Technology during the "13th Five-Year Plan", "Special digital diagnosis and treatment equipment".

In November 2022, the artificial blood vessel of Jiangsu Baiyuda Life Technology Co., Ltd. was approved, which was the first domestic artificial blood vessel approved for listing in China, and solved the "neck" technical problem of artificial blood vessel. Artificial blood vessel is a substitute for severe stenosis or occlusion, mainly used for replacement or bypass operation of aorta and its branches. Previously, the global artificial blood vessel market was almost monopolized by two major multinational enterprises, Telmo and Maccorvee.

The "disposable pressure detection magnetic positioning radiofrequency catheter" of Shanghai Microinvasive Electrophysiology Medical Technology Co., Ltd. was approved for listing on December 1, 2022. It is the first domestic radiofrequency catheter with pressure sensing function. This product is used in medical institutions in conjunction with the three-dimensional cardiac electrophysiological mapping system and the cardiac radiofrequency ablation instrument produced by Shanghai Microinvasive Electrophysiology Co., Ltd. for the treatment of drug-refractory, recurrent, and symptomatic paroxysmal atrial fibrillation, which can effectively prevent the steam burst or incomplete ablation caused by excessive adhesion between the catheter and the tissue during the operation.

The medical angiographic X-ray machine developed by Lianying Medical was approved for marketing on December 30, 2022. It is the last innovative medical device of three categories approved for marketing in 2022. It is suitable for providing X-ray fluoroscopy, photography, vascular subtraction image and body image during angiography and interventional surgery. The product adopts 9-axis robot DSA (new low-dose digital subtraction angiography X-ray imaging system), which can realize cone-beam imaging of the whole abdomen and chest, and solve the problem of small field of vision reconstruction of traditional cone-beam CT.

In 2023, domestic innovative medical device products are still receiving good news. On January 5, Hanoi Medical's domestic extracorporeal membrane oxygenation therapy (ECMO) product was officially approved for the market. This product will be used for adult patients with acute respiratory failure or acute cardiopulmonary failure, other treatment methods are difficult to control, and there is a foreseeable risk of continuous deterioration or death, realizing the localization breakthrough of "artificial lung" from zero to one.


Photo source: Sorted by China Commercial Industry Research Institute


On the whole, the current medical device has entered a golden period of development, and the high-end medical device field continues to enjoy favorable policies. According to the analysis of Gaohe Investment Research Center, the development cycle of China's medical device market is later than that of the pharmaceutical industry, the import substitution of Class II and III medical devices is not sufficient, the late-developing advantage and demand potential are large, and the industry ceiling is high. But at the same time, compared with the pharmaceutical sector, the medical device sector is more difficult to appear industry subverters. The brand effect is obvious, and the logic of the strong is more applicable. The leading enterprises in the industry have long-term competition barriers, so they need long-term industrial policy support at the national level.

Domestic substitution and technological innovation are the main development lines of the medical device industry. The reform of centralized volume procurement and medical insurance payment has constantly squeezed the industry's moisture and forced the industry's reform and innovation. In addition, the frequent occurrence of incentive policies has promoted the innovation and R&D capabilities of domestic medical device enterprises to continuously improve.

As the domestic epidemic prevention and control has entered a new cycle, the domestic medical device market is also expected to recover. There is a long way to go, but only a struggle. The medical device enterprises will have more endurance, accumulate and develop in the cold winter, and look forward to the rapid development of the medical device industry in 2023.


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