NMPA Accelerates Innovative Medical Device Approvals; NHSA Launches Pre-Pricing Pilot to Shorten Time-to-Market for China Market Entry
China's National Medical Products Administration (NMPA) has approved 51 innovative medical devices year-to-date in 2026 and pledged to further accelerate review pathways for emerging technologies including brain-computer interfaces. In parallel, the National Healthcare Security Administration (NHSA) launched a nationwide pre-pricing pilot that initiates pricing evaluation before market authorization, aiming to compress the lag between NMPA approval and clinical reimbursement for innovative medical technologies.
01NMPA Innovation Pipeline Gains Momentum
At a September 20, 2026 press conference, NMPA Deputy Commissioner Yang Sheng announced that China has approved 59 innovative drugs and 51 innovative medical devices for market launch so far this year. The agency reported that 76 innovative medical devices were approved in full-year 2025, a 17% year-on-year increase, while 25 devices entered the priority approval pathway, up 212.5% from the prior year. NMPA also committed to strengthening early-stage consultation with manufacturers, particularly for products involving new targets and mechanisms, and to developing trial and review guidelines for emerging technologies including brain-computer interfaces (BCI). For overseas brands, these figures signal that China's regulatory system is increasingly approving innovations at the same time as — and occasionally ahead of — other major markets, making China regulatory strategy a core component of global product planning rather than a late-stage market-entry exercise.
02NHSA Pre-Pricing Pilot Aligns Reimbursement with Approval
In a policy document released around September 16, 2026, the National Healthcare Security Administration (NHSA) launched a nationwide pre-pricing pilot for innovative medical products. Under the program, provincial-level healthcare security authorities will begin pricing guidance and evaluation at an earlier stage — before a product receives market authorization, such as when a new technology enters clinical research or a new device enters the special review process. The pilot applies to three categories: breakthrough diagnostic and therapeutic technologies, advanced equipment that meets critical clinical needs while improving precision and efficiency, and innovative consumables that fill care gaps and transform surgical protocols. To date, the NHSA has issued 40 batches of unified pricing catalogs covering more than 200 medical service items, including emerging technologies such as proton radiotherapy, surgical robots, remote surgery, and brain-computer interface implantation. Once a product gains NMPA approval, provincial authorities can add the pricing item through an accelerated green channel, enabling faster patient access.
03Post-Market Compliance Signal: NMPA Cancels 11 Registration Certificates
On September 23, 2026, the NMPA published Announcement No. 95 (2026), cancelling 11 medical device registration certificates at the request of the manufacturers. Notably, 8 of the 11 cancelled certificates were for imported products — seven from Cook Australia (including IVF culture media and vitrification kits) and one dental alloy from Germany's Adentatec GmbH. While these were voluntary cancellations rather than safety-driven suspensions, the volume of imported product cancellations underscores the importance of active portfolio management for overseas manufacturers holding NMPA certificates. Foreign brands should regularly review their China registration portfolio, ensure authorized agents maintain post-market surveillance obligations, and proactively manage certificate lifecycles to avoid lapses that could disrupt market access. The announcement also follows a series of recent import-suspension actions by NMPA, signaling continued vigilance on post-market compliance for both domestic and imported devices.
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