NMPA Releases Medical Device Approval Delivery Information for August 12, 2026

On August 12, 2026, China’s National Medical Products Administration officially released the latest delivery information for medical device approval certificates. Since November 1, 2022, applicants have been able to access electronic certificates through the NMPA Government Service Portal’s corporate space and print them as needed. This batch covers a total of 122 products, spanning cardiovascular interventions, blood purification, surgical and energy devices, imaging diagnostics, in vitro diagnostics, and imported devices. The list includes both new registrations and numerous renewal approvals.

In the cardiovascular segment, key approvals include the integrated occluder delivery system from Xuzhou Yatai Technology, the coronary metal stent delivery system from Liaoning Yinyi, the implantable rechargeable spinal cord neurostimulator from Beijing PINS, and the abdominal aortic stent graft system from Lifetech Scientific. For blood purification, the hemodialysis equipment from Guangzhou Sainuokang, the continuous blood purification tubing set from Chongqing Tianwaitian, and the high‑flux polyethersulfone hollow fiber hemodialyzer from Chengdu Ousai all received the green light. In surgical and energy devices, notable names include the high‑frequency surgical equipment from Guangdong Baisheng, the single‑use powered endoscopic linear stapler from Seno Medical, and the ultrasonic soft tissue cutting and coagulation device from Taihui Medical. Imaging diagnostics saw approvals for Fujifilm’s color ultrasound diagnostic equipment, Planmed Oy’s digital X‑ray tomography system, and Siemens’ ultrasound diagnostic system.

On the IVD front, the total PSA assay kit from Xiamen Wantai, the tuberculosis‑specific cell‑mediated immune response assay kit from Zhengzhou Autobio, and the human HLA‑B*5801 genotyping kit from Suzhou Tianlong were among those approved. Imported products were also well represented, with clearances for Roche Diagnostics, Medtronic, Covidien, Siemens Healthineers, BD, and Boston Scientific, covering fully automated chemiluminescence immunoanalyzers, continuous glucose monitoring systems, and implantable pacemaker leads, among others.

In addition, a substantial number of renewal registrations were published, including orthopedic implants, soft hydrophilic contact lenses, high‑frequency surgical equipment, and real‑time PCR analyzers, ensuring continued compliance and supply of existing products. Overall, this batch demonstrates the NMPA’s ongoing commitment to supporting innovation and quality in medical devices, while providing clear regulatory direction for the industry.