With frequent policy support, China’s innovative medical devices usher in a golden opportunity period
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 domestic medical device industry.
01.The domestic medical device industry is booming and its revenue continues to grow
According to relevant industry reports, the operating revenue of China’s medical device industry in 2021 reached about 1.156 trillion yuan, with a year-on-year growth of 11.24%. In 2022, the revenue of China’s medical device industry reached 1.3 trillion yuan, with a growth rate of about 12%. From January to November 2022, China’s total export volume of medical devices reached 444.179 billion yuan, with an average annual compound growth rate of 10.2%. The report also predicts that the compound growth rate of Chinese medical device industry will maintain rapid expansion in the coming period of time.
In addition, the number of medical device products registered for the first time has grown steadily. In 2022, the NMPA approved the first registration of 2,172 third-class medical devices, of which 1,818 were made in China and 354 were imported. Provincial-level drug regulatory authorities approved 13,063 domestic Category II medical devices for registration in 2022, and 27,117 category I medical devices for filing. More and more Chinese companies 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.
- The state frequently promulgates favorable policies for medical devices
In 2014, the NMPA issued the Special Examination and Approval Procedure for Innovative Medical Devices (Trial), and in 2018, after modification and improvement, the NMPA issued the Special Examination and Approval Procedure for Innovative Medical Devices, which set up special examination and approval channels for medical devices that have Chinese invention patents, are the first of its kind in China and the leading level in the world, and have significant clinical application value. Relevant departments shall give priority to innovative medical devices in accordance with the principles of early intervention, dedicated personnel and whole-process guidance, and on the premise of no reduction in standards and procedures. In 2016, the NMPA issued the Procedure for Priority Approval of Medical Devices, giving priority to medical devices listed in national major science and technology projects or key research and development plans, medical devices for the diagnosis or treatment of rare diseases, malignant tumors, diseases unique to the elderly and multiple diseases, medical devices dedicated to children and medical devices in urgent clinical need, so as to promote the launch of such products as soon as possible.
In December 2021, the NMPA issued the 14th Five-Year Plan for the Development of Medical Equipment Industry, proposing to optimize the registration and review process of innovative medical equipment, supporting medical equipment with invention patents and significant clinical application value to enter the special approval channel and give priority to approval.
Domestic substitution of medical devices is also expected to accelerate. Since 2021, Zhejiang, Guangdong and other provinces in China have issued the latest version of the Purchase List of Imported medical equipment. Even if the equipment entered the purchase list, it must be purchased for reasonable reasons 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 were 59 kinds of medical equipment that can be imported, while in Guangdong Province, the number was 46.
For innovative medical devices, the policy level also leaves a certain market space beyond centralized purchase. In the centralized procurement process, medical institutions determine the purchase volume based on historical usage, combined with clinical use and medical technology progress, the State Drug Administration said in a reply to NPC deputies in September 2022. As the clinical use of innovative medical devices is not yet mature and the usage is difficult to estimate temporarily, it is difficult to implement the centralized procurement.
03.”Innovation” is still the main theme in the field of medical devices
In 2022, the NMPA announced that 55 third-class medical devices were approved for market, and the number of innovative medical devices approved increased by 57.1% compared with 2021. Several products also achieved major technological breakthroughs in the global scope.
In April 2022, Yuanhuatechch. Auxiliary knee robot obtained marketing approval from the NMPA, filling the vacancy in the domestic robot-assisted joint replacement market; Xingaoyi Medical Equipment Co.,Ltd. With its latest approved series of liquid helium-free products, it obtained the registration certificate of innovative medical device from the NMPA in April 2022. It is the world’s first 100% liquid helium-free superconducting magnetic resonance imaging system.
Shanghai Apactron Proton Therapy System was approved for sale in September 2022. It is the first domestically produced proton therapy system approved for sale in China. It is suitable for the treatment of systemic solid malignant tumors and certain benign diseases.
In November 2022, Jiangsu Bioda Life Science Co. Ltd. ‘s artificial blood vessel was approved, which was the first domestic artificial blood vessel approved to be listed in China and solved the technical problem of “bottlenecking” artificial blood vessel.
Shanghai MicroPort EP MedTech Co., Ltd “Shanghai MicroPort EP MedTech Co., Ltd. “Single-Use Pressure Detection Magnetic Positioning radiofrequency Ablation Catheter”, approved on December 1, 2022, is the first domestic cardiac radiofrequency ablation catheter with pressure-sensing function. This product is used in combination with the three-dimensional cardiac electrophysiological mapping system and the radiofrequency ablation instrument produced by Shanghai MicroPort EP MedTech Co., Ltd. It is used in the treatment of refractory, recurrent and symptomatic paroxysmal atrial fibrillation, and can effectively prevent the steam burst caused by too much adhesion force between the catheter and the tissue during surgery or the incomplete ablation caused by too small.
The medical angiography X-ray machine developed by United Imaging Medical was approved for market on December 30, 2022. It is the last of three innovative medical devices to be approved for market in 2022. It is suitable for providing X-ray fluoroscopy, photography, vascular subtraction image and body layer image during angiography and interventional surgery. This product adopts 9-axis robot DSA(a new low-dose digital subtraction angiography X-ray imaging system), which can realize conical beam imaging of the whole abdomen and the whole chest, and solve the problem of small field of vision in traditional conical beam CT reconstruction.
In the year of 2023, on January 5, CBM’s domestic extracorporeal membrane oxygenation (ECMO) product was officially approved for market. The product will be used for adult patients with acute respiratory failure or acute cardiopulmonary failure, who are difficult to control with other treatments and have a predictable risk of continuous deterioration or death, achieving a breakthrough in the localization of “artificial lung” from zero to one.
04.Domestic medical device industry will usher in great development opportunities
GHICapital pointed out that 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. The leading enterprises in this industry have long-term competition barriers, so they need long-term industrial policy support at the national level.
Source：Medical Device Innovation Network
Translated & edited by Bradyknows
