NMPA Announces 258 Medical Devices Approved in September 2026

On October 15, 2026, China's National Medical Products Administration released Announcement No. 101 of 2026, detailing the medical device registration approvals for September 2026. A total of 258 medical device products were approved during the month, spanning in vitro diagnostic reagents, medical imaging equipment, implantable and interventional devices, surgical navigation systems, and more.

Breaking down the registration structure: 212 Class III domestic medical devices were approved, accounting for over 82% of the total and maintaining an absolute dominant position. This was followed by 22 Class III imported devices, 22 Class II imported devices, and 2 devices from Hong Kong, Macao, and Taiwan.These figures reflect the continued strengthening of China's domestic medical device innovation capabilities, as well as ongoing improvements in regulatory review and approval efficiency.

Notably, several high-end innovative devices received approval this month. These include a continuous glucose monitoring system (Sinocare), an extracorporeal membrane oxygenation (ECMO) device (Suzhou Hengrui Hongyuan), an orthopedic surgical navigation system (Chongqing Boscom), and multiple respiratory pathogen detection kits. These approvals signal accelerating breakthroughs by domestic manufacturers in chronic disease management, life support, and precision surgery.

In terms of product categories, in vitro diagnostic (IVD) reagents remained the most numerous approved category, covering detection for dengue virus, Mycoplasma pneumoniae, Epstein-Barr virus, influenza A/B viruses, human papillomavirus, and more. Meanwhile, clinically urgent devices such as neuromonitoring endotracheal tubes, coronary balloon dilation catheters, and peripheral thrombus aspiration catheters also secured approval, further enriching the domestic market supply.

From a policy perspective, the NMPA continues to optimize its review and approval processes while encouraging medical device innovation. The September 2026 approval volume rebounded from 243 in August, indicating that the regulator is actively facilitating faster market access for innovative products while ensuring safety and efficacy, ultimately providing patients with more treatment options.

For medical device companies, obtaining NMPA registration approval marks a critical milestone for market entry in China. As the highest-risk category, Class III devices undergo rigorous clinical evaluation and technical review. Approval not only signifies official recognition of a product's safety and efficacy but also lays a solid foundation for subsequent market promotion and channel expansion.