NMPA Lays Out 15th Five-Year Plan for Innovative Medical Devices; 51 Innovative Devices Approved YTD
On September 20, 2026, NMPA Deputy Director Yang Sheng announced the 15th Five-Year Plan roadmap for innovative medical devices at a State Council Information Office press conference, revealing that 51 innovative medical devices have been approved year-to-date. The plan expands the 'Spring Rain Action' clinical-transformation program into frontier fields such as brain-computer interfaces, establishes market exclusivity for pediatric and rare-disease products, and explicitly encourages foreign manufacturers to produce high-end medical equipment domestically.
01NMPA's 15th Five-Year Plan: Accelerating Innovative Device Approvals
Speaking at the September 20 press conference, NMPA Deputy Director Yang Sheng reported that China has approved 59 innovative drugs and 51 innovative medical devices so far in 2026, signaling sustained momentum in medical device innovation. Under the 15th Five-Year Plan, NMPA will concentrate its best review resources to let 'China-made, globally novel' innovative drugs and devices reach the market faster. Key measures include advancing the pharmaceutical test-data protection system, establishing market exclusivity periods for pediatric and rare-disease products to safeguard R&D returns, and streamlining early-stage R&D communication mechanisms to reduce development detours. The administration will also compress review and approval timelines for clinically urgent products and open priority testing green channels, shifting from 'patients waiting for drugs' to 'drugs waiting for patients.'
02Spring Rain Action Expands to BCI; NHSA Pilots Pre-Pricing for Innovations
NMPA will expand the 'Spring Rain Action' (春雨行动) clinical-innovation transformation program into frontier sectors such as brain-computer interfaces (BCI), where dedicated clinical-trial and review guidance will be developed to pave the way for future industries. In parallel, the National Healthcare Security Administration (NHSA) launched a pre-pricing pilot on September 15, under which provincial-level healthcare security authorities will begin pricing guidance and evaluation at an earlier stage—when a new technology enters clinical research or a new device enters the special review process—rather than waiting until after market authorization. The pilot covers three categories: breakthrough diagnostic/therapeutic technologies, high-value equipment addressing major unmet clinical needs, and novel consumables that fill treatment gaps. The goal is to achieve seamless alignment between regulatory approval and pricing guidelines so that innovations reach patients faster.
03Implications for Foreign Medical Device Manufacturers
The 15th Five-Year Plan explicitly supports wider opening-up in the medical sector: NMPA encourages foreign investors to bring original drugs and high-end medical equipment into domestic production in China, while also supporting Chinese companies going global. For overseas device manufacturers, this creates a dual opportunity. On the regulatory side, the accelerated review pathway, priority testing green channels, and expanded Spring Rain Action mean faster time-to-market for genuinely innovative products, especially in BCI, AI diagnostics, and advanced therapeutic equipment. On the market-access side, the NHSA pre-pricing pilot shortens the historically long lag between NMPA approval and inclusion in medical insurance charging catalogs. Foreign firms with breakthrough technologies should proactively engage both NMPA's early-communication channels and provincial NHSA pre-pricing processes to maximize speed-to-patient. Manufacturers should also prepare for the new BCI clinical-trial and review guidance expected under the expanded Spring Rain Action.
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