Can the 10-Day Path from Regulatory Approval to National Reimbursement Be Replicated for Innovative Medical Devices?

Brain-computer interface sets a new record for innovative medical devices from approval to medical insurance implementation.

On March 13, 2026, Neuracle's implantable brain-computer interface system for hand motor function compensation was approved for marketing by the National Medical Products Administration, becoming the world's first approved invasive brain-computer interface.

On March 15, the National Healthcare Security Administration took the initiative to connect and complete the medical insurance coding for the product, clearing a key link from its approval to clinical application.

On March 23, after the National Healthcare Security Administration released the brain-computer interface product catalog and coding, the Shanghai healthcare security department quickly reviewed it through a green channel and included brain-computer interfaces in the Shanghai medical consumables directory.

On March 24, the medical insurance department assisted the company in successfully listing its brain-computer interface product on the Sunshine Procurement Platform.

From product approval to inclusion in medical insurance, it took only 10 days. Undoubtedly, the medical insurance coding and inclusion will greatly enhance the accessibility of brain-computer interfaces and accelerate their practical application.

What needs to be considered is:Is the brain-computer interface an exception or a benchmark case? Can other innovative medical devices replicate this path? Will the clinical translation of innovative medical devices accelerate?

First, it should be noted that the approval of brain-computer interface for medical insurance within 10 days is a benchmark case for innovative medical devices.

Deputy Director of the Price and Bidding Department of China's National Healthcare Security Administration, Dong Zhaohui, previously stated: "The National Healthcare Security Administration continues to promote the rapid clinical adoption and large-scale application of advanced new technologies and products. Pricing initiatives are also accelerating the transition of innovative technologies such as brain-computer interfaces from the laboratory to clinical settings."

The National Healthcare Security Administration also issued a call: All medical device companies dedicated to innovation are welcome to actively strengthen communication and coordination with healthcare security departments, and to provide feedback on product classification suggestions. Let us consolidate our efforts to promote the efficient transformation and application of innovative products, empower the industry through healthcare security, and enable more "Intelligent Made in China" products to become strong safeguards for protecting people's health.

In fact, the smooth and rapid inclusion of brain-computer interfaces in medical insurance is closely related to the local government's vigorous development of the brain-computer interface industry and relevant enterprises' strengthened communication with medical insurance departments.

At the beginning of 2025, Shanghai released the "Shanghai Brain-Computer Interface Future Industry Cultivation Action Plan (2025-2030)", aiming to build a brain-computer interface industry. It pointed out that: the application of invasive and semi-invasive brain-computer interface technologies and products should be accelerated. Support for including brain-computer interface products in the medical insurance charging directory.

Prior to this, several brain-computer interface enterprises in Shanghai have been actively engaging in in-depth communications with the medical insurance departments since 2024, promptly updating on the product’s R&D progress, technical features, product approvals, and other matters. In response, the Shanghai Municipal Medical Insurance Bureau has been proactively organizing the medical insurance support policies and procedures for innovative medical devices based on the enterprises' needs, providing them with a clear pathway and policy expectations.

In July 2025, relevant officials from the Shanghai Municipal Medical Insurance Bureau visited Shaonao Technology to research "the adaptation of brain-computer interface technology to medical insurance policies and its clinical transformation implementation," laying the groundwork for subsequently including brain-computer interfaces in medical insurance.

In fact, not only brain-computer interfaces, but also innovative medical devices such as artificial hearts, surgical robots, PFA, proton and heavy ion have received strong support from local government policies in recent years.

Taking artificial hearts as an example, as a "life-saving device" for end-stage heart failure patients, artificial hearts have long faced the dilemma of "high prices and unaffordability for patients" due to their high technical difficulty and large R&D investment. To promote the clinical implementation of this innovative product, the National Healthcare Security Administration proactively communicated and negotiated with artificial heart manufacturers, guiding companies to appropriately reduce terminal listing prices. This effort brought down the overall cost of artificial heart implant surgeries from millions of yuan to around 700,000 yuan. Among them, Aerospace Tixin voluntarily reduced its product price to 499,000 yuan per set, easing the financial burden on patients. Meanwhile, regions such as Tianjin have included medical services and consumables related to artificial hearts (ventricular assist devices) in the scope of medical insurance reimbursement, further improving the accessibility of artificial hearts.

It is expected that after the brain-computer interface, an increasing number of innovative medical companies will strengthen communication with medical insurance departments to promote quicker inclusion of more innovative medical devices into medical insurance, ultimately benefiting more patients in China.

If medical insurance access is the "last mile" for the implementation of innovative medical devices, then the establishment of medical service pricing is the key prerequisite to打通 this "last mile." In the past, gaining market approval for innovative medical devices was only the "first step of a long march," and subsequent commercial implementation still faced many obstacles, with the most prominent pain points being the "difficulty in price filing and high barriers to hospital entry."

Previously, innovative medical devices had to complete price filing and establish medical service charge standards before entering hospital clinical applications. Without price filing, hospitals could not legally charge related fees, thus were unable to include the products in their procurement catalog. As a result, even if the product was approved for marketing, it remained difficult to be adopted by medical institutions to serve patients.

More crucially, the price filing adopts a "province-by-province submission" model. The approval standards vary across provinces, and the review cycles differ, with some provinces having review cycles as long as 6 to 12 months. Enterprises need to invest significant manpower, material resources, and financial resources for cross-provincial submissions, which is not only time-consuming and labor-intensive but also leads to products being unable to achieve rapid coverage across China.

Moreover, due to the lack of a unified standard for medical service pricing, even if some innovative medical devices complete price filing, there are still significant differences in charging standards. This not only affects the clinical accessibility of the products but also increases the burden on patients. Taking surgical robots as an example, most regions address robot charging issues through methods such as referencing instruments, bundling, or adding fees, resulting in non-uniform projects and unclear standards.

To address this pain point, the National Healthcare Security Administration has issued guidelines for the establishment of medical service price projects, unifying and integrating the pricing of medical services in the Chinese market. Brain-computer interfaces are just one typical example among many innovative medical devices that have benefited, reflecting the systematic support from the National Healthcare Security Administration for innovative medical technologies.

As early as 2023-2024, the National Healthcare Security Administration had begun to make advance arrangements, conducting several research trips to Zhejiang, Shanghai, and other places. The focus was on examining the brain-computer interface R&D progress of companies such as Neuracle and other enterprises, gaining an in-depth understanding of the clinical application scenarios, technical features, cost structures, and patient needs of brain-computer interfaces, laying the groundwork for subsequent pricing projects.

At the same time, the National Healthcare Security Administration also collects opinions from all parties through various methods such as public solicitation of opinions, holding corporate symposiums, and inviting clinical experts for论证, ensuring the scientificity and rationality of pricing projects. This approach not only guarantees reasonable profits for enterprises but also balances the burden on patients and the sustainability of the healthcare security fund.

Based on thorough research and论证, the National Healthcare Security Administration issued the "Guidelines for the Establishment of Price Items for Neurological Medical Services (Trial)" in March 2025, which specifically established independent projects for brain-computer interface technology, including "Invasive Brain-Computer Interface Implantation Fee," "Invasive Brain-Computer Interface Removal Fee," and "Non-Invasive Brain-Computer Interface Fitting Fee."

This means that one year before Neuracle's invasive brain-computer interface product is approved for marketing in March 2026, the clinical use of such products has already completed the medical service price establishment, paving the way for the "last kilometer" from approval to clinical application in advance.

As of now, most provinces in China have formulated government-guided prices for brain-computer interface-related price projects based on the project initiation guidelines from the National Healthcare Security Administration. Among these, the cost for invasive brain-computer interface implantation is concentrated around 6,000-6,600 RMB per session, while the fitting fee for non-invasive brain-computer interfaces is around 960 RMB.

The pricing approval for brain-computer interfaces is just one example of the National Healthcare Security Administration's efforts to promote the clinical transformation of innovative medical devices. According to the latest data from the National Healthcare Security Administration, as of April 2026, it has issued guidelines for 39 batches of medical service price projects, adding approximately 180 forward-looking price projects involving new technologies and products such as surgical robots, remote surgery, brain-computer interfaces, artificial hearts, cochlear implants, artificial larynxes, HIFU knives, and digital pathology slides. These provide clear charging standards for the clinical application of these new technologies, resolving past challenges in clinical transformation where "innovative technologies had products but no charging mechanisms."

Among the newly added pricing items, the pricing projects for surgical robots and artificial hearts are the most representative. Previously, the charging standards for surgical robots were mainly set autonomously by hospitals, lacking a unified standard. The pricing guidelines issued by the National Healthcare Security Administration have made the charging of surgical robots "legally compliant," with a fee structure centered on clinical value, favoring products that participate in more surgical steps and perform more precise operations.

More notably, the National Healthcare Security Administration is actively exploring the establishment of a pre-project approval system for medical service pricing, further advancing the early intervention in price management of innovative technologies. Under this system, during the clinical trial phase of new technologies and products, the healthcare security department will provide early guidance on pricing policies, advising companies to reasonably estimate costs and formulate pricing strategies. At the same time, it will proactively clarify the procedures and requirements for price project approval, facilitating the rapid completion of project approval after product authorization, thereby further accelerating the market transformation efficiency of high-level innovative achievements.

From the establishment of medical service prices to the inclusion in the medical insurance directory, the country is promoting the accelerated clinical transformation of innovative medical devices through institutional design, allowing truly innovative and high-quality products to be used on patients faster and better. Perhaps, the golden age of innovative medical devices has really arrived.

The case of Brain-Computer Interface "10-day inclusion in medical insurance" is a key milestone in the continuous upgrading of China's innovative medical device support policies, and the result of a series of policy synergies at both national and local levels.

Nowadays, with the release of more and more policies, the accelerated application of innovative medical devices is being promoted. Innovative medical devices are entering a "golden age" of implementation.

At the national level, in July 2025, the National Healthcare Security Administration (NHSA) held five consecutive symposiums focusing specifically on "healthcare support for innovative drugs and medical devices," covering the entire lifecycle of innovative drugs and medical devices from research and development, clinical application to healthcare access. During the second symposium, the main leader of the NHSA's Price and Tendering Department stated: efforts should be made to accelerate the clinical application of high-level scientific and technological innovation achievements; to help Chinese innovative drugs and medical devices reach the global market and promote the globalization of pharmaceuticals.

At the local level, several cities such as Beijing, Shanghai, and Shenzhen have introduced targeted policies to refine support measures for innovative medical devices, accelerating the implementation of innovative products.

In April 2026, the Beijing Municipal Medical Security Bureau and nine other departments released the "Several Measures of Beijing Municipality to Support High-Quality Development of Innovative Pharmaceuticals (2026)." The Measures pointed out: An incentive and restraint mechanism should be established, incorporating the inclusion of nationally negotiated medicines and innovative medical devices into hospital evaluations while excluding their impact on assessment indicators such as average cost per visit. Innovative pharmaceuticals and devices should be supported for inclusion in commercial insurance coverage.

Regarding the clinical promotion of surgical robots, the Measures also proposed four specific requirements, such as conducting clinical effectiveness evaluations and health technology assessments of surgical robot applications, accelerating the adoption of full-category surgical robots in hospitals for laparoscopic, orthopedic, neurosurgery, interventional procedures, and utilizing leasing platforms for high-value medical equipment like robots.

In addition, the Measures also propose: For Class 1 innovative drugs and devices that are directly led by medical institutions in clinical research and subsequent commercialization, they should be prioritized for in-hospital use upon market entry.

Shanghai's Action Plan for the Comprehensive Development of the High-End Medical Device Industry Chain shows: Accelerate the promotion of innovative medical devices. Continuously update the "New and Excellent Pharmaceuticals and Medical Devices" catalog, promptly including medical device products approved under the National Innovative Medical Device Special Review Program. Public medical institutions should conduct hospital entry evaluations and reviews within 30 days after the catalog is updated to support the provision and use of innovative medical devices.

Shenzhen supports the application and promotion of innovative products through the "Several Measures for Full-chain Support of Pharmaceutical and Medical Device Development in Shenzhen": with stronger support for innovative drugs and devices that are highly innovative, have proven efficacy, and are urgently needed in clinical settings to enter hospitals and medical insurance, and vigorously developing the "first launch economy." Public medical institutions are encouraged to convene pharmaceutical affairs meetings within one month after the release of the national medical insurance negotiation drug list, and to equip and use according to the principle of "full allocation where necessary" based on clinical needs and hospital characteristics.

In addition to Beijing, Shanghai, and Shenzhen, multiple provinces including Tianjin, Shandong, and Zhejiang have also introduced relevant policies to promote the implementation of innovative medical devices. For instance, Tianjin has included innovative medical devices such as artificial hearts in the scope of medical insurance payments, Shandong is accelerating the transparent procurement of innovative medical devices, and Zhejiang has issued an incentive management method for medical insurance payments on innovative pharmaceutical technologies. The introduction of these policies will accelerate the implementation and penetration of innovative medical devices.

Reviewing the entire process of the "10-day inclusion in medical insurance" for brain-computer interfaces, it is clear that this rapid implementation path is not an irreplicable exception, but rather the result of the collaborative efforts of "policy pre-planning, precise pricing, local efficient execution, and proactive corporate engagement." The underlying logic and experience provide a reference and replicable model for the clinical transformation of other innovative medical devices.

Of course, we must also soberly recognize that while the path of brain-computer interfaces can be replicated, not all innovative medical devices can completely follow this model. For innovative medical devices to achieve rapid implementation, three core conditions must be met: First, the product must have significant clinical value and address unmet clinical needs—this is the key prerequisite for gaining policy support. Second, companies must proactively strengthen communication with medical insurance departments and medical institutions, promptly provide product information, and cooperate in policy implementation. Third, local governments should refine supportive measures based on regional industrial characteristics to offer precise services for innovative products.

With the continuous efforts of policies and the continuous improvement of systems, it is believed that more innovative medical devices will follow this path in the future, quickly moving from the laboratory to clinical applications, benefiting thousands of patients.