China's medical device industry maintains rapid growth and has become the world's second-largest market. During the ongoing China International Dental Equipment & Materials Exhibition and Technical Symposium, Neo Modulus launched its gelatin-polycaprolactone layered gingival repair membrane (commercial name: Venovo). This is the first domestically approved innovative dental implant medical device since the implementation of the Special Approval Procedure for Innovative Medical Devices (Trial) in 2014.
Approval Policy Optimization
Periodontal disease treatment and periodontal defect restoration are the foundation of "periodontal escort," and at the same time, a globally recognized challenge. In recent years, the health and aesthetics of oral soft tissues have increasingly drawn the attention of both doctors and patients. The free gingival graft (FGG) is currently the gold standard for increasing keratinized gingiva width. However, due to issues such as the need for a secondary surgical site, limited donor tissue availability, and significant postoperative discomfort for patients, FGG presents challenges like high surgical difficulty and low patient acceptance. Neo Modulus has pioneered the use of submicron-level scaffold materials, which can rapidly guide the regeneration of natural gums without the need for a secondary surgical site. This method achieves the same effect as FGG in widening keratinized gingiva, not only reducing surgical time but also enhancing patient comfort.
Since the National Medical Products Administration released the 'Special Approval Procedure for Innovative Medical Devices (Trial)' in 2014, Neo Modulus has become the first approved innovative medical device for oral implantation in China. Innovative medical devices produced in China, including those for oral implantation, have also been experiencing rapid development in recent years. Data released by the National Medical Products Administration shows that China's medical device industry achieved a main business revenue of 1.3 trillion yuan in 2023, making China the world’s second-largest market after the United States.
This is inseparable from the boost provided by approval policies. Following the aforementioned special approval process, the National Medical Products Administration (NMPA) issued the "Special Review Procedure for Innovative Medical Devices" in 2018 after revisions and improvements. This policy establishes a special approval channel for medical devices that have obtained Chinese invention patents, are domestically首创in technology, reach an internationally leading level, and possess significant clinical application value. Relevant departments, adhering to the principles of early intervention, designated personnel responsibility, and full-process guidance, prioritize the handling of innovative medical devices without lowering standards or reducing procedures, while enhancing communication with applicants. In 2016, the NMPA issued the "Priority Approval Procedure for Medical Devices," granting priority approval to medical devices listed under national science and technology major projects or key research and development plans, as well as those used for diagnosing or treating rare diseases, malignant tumors, diseases unique or common among the elderly, pediatric-specific medical devices, and clinically urgently needed medical devices, thereby promoting their quicker market entry.
The Problem of "Small and Scattered" Medical Device Companies Still Exists
Under the dividend of approval policies, the approval speed of medical device products in China has increased. In 2022, the National Medical Products Administration (NMPA) announced that 54 Class III medical devices were approved for marketing, a significant increase from 35 in 2021. Additionally, in 2022, a total of 67 Class III medical devices entered the innovative approval fast track, slightly more than the 60 in 2021. Among the approved Class III medical devices, there were some high-end devices solving "bottleneck" technical problems, such as proton therapy systems and artificial blood vessels. By 2023, the number of approved innovative medical devices reached a new high of 61, with 12 devices receiving priority approval.
For innovative medical devices, policy-level measures have left some market space outside of bulk procurement. In September 2022, the National Medical Products Administration (NMPA) responded to representatives of the National People's Congress of China, stating that during the centralized bulk procurement process, medical institutions determine procurement volumes based on historical usage, combined with clinical application and advancements in medical technology. Since the clinical application of innovative medical devices is not yet mature and their usage volume is temporarily difficult to estimate, it is challenging to implement a bulk procurement approach. During the centralized bulk procurement process, the National Healthcare Security Administration (NHSA) will reasonably determine the bulk procurement ratio based on clinical application characteristics, market competition landscape, and the number of selected enterprises, leaving some market space outside of centralized bulk procurement to provide room for innovative products to expand their market.
Of course, the development of China's medical device industry still faces specific problems. Public data shows that the number of China's medical device manufacturing enterprises has increased from 18,070 at the end of 2019 to 26,465 by the end of 2020, a rise of 46%. Some analyses point out that over 90% of China’s medical device manufacturers are small and medium-sized enterprises, with an average annual main business revenue of 30 to 40 million yuan, presenting a "small and scattered" situation. Compared with the average annual main business revenue of 300 to 400 million yuan in China's pharmaceutical industry, there is still a significant gap.
Reporter Zhang Xiulan from The Beijing News
Proofread by Wang Xin