NMPA Releases Medical Device Approval Certificate Delivery Information for September 7, 2026

On September 7, 2026, the National Medical Products Administration published the latest batch of medical device approval certificate delivery information. A total of 42 products were covered in this release, with approval dates primarily concentrated on September 4, 2026, spanning domestic Class III medical devices, imported medical devices, and renewal registrations.

In terms of product categories, this batch demonstrates broad coverage. In the imaging diagnostics segment, GE Medical Systems (China)'s color ultrasound diagnostic system, Neusoft Medical's X-ray computed tomography equipment, two models of medical angiography X-ray systems from Beijing GE Huarun Medical Devices, and Shenyang Zhineng Medical Technology's PET/CT system were all approved. In the cardiovascular and critical care space, Suzhou Hengrui Hongyuan Medical Technology's ECMO system and Anjun Medical Technology's thrombus aspiration negative pressure pump received registration certificates. Two orthopedic surgical navigation systems, from Tuodao Medical Technology and Chongqing Boshi Kang Technology, were approved simultaneously.

In vitro diagnostic (IVD) reagents stood out as a major highlight in this approval batch. Multiple respiratory pathogen detection products received approval, including Guangzhou Baochuang Biotechnology's influenza A/B and respiratory syncytial virus antigen detection kit, Zhuhai Livzon Diagnostics' multiplex respiratory pathogen antigen detection kit, and Suzhou Tianlong Biotechnology's influenza A/B and respiratory syncytial virus nucleic acid detection kit. Additionally, Zhengzhou Autobio's chemiluminescence immunoassay kits, Nanjing Dongke Zhisheng Gene Technology's gene methylation detection kit, and Beijing Wantai Biological Pharmacy's hepatitis E virus nucleic acid detection kit were also among the approvals.

On the imported products front, Medtronic's implantable cardiac resynchronization therapy defibrillator and Apple Inc.'s mobile sleep apnea notification software received approvals. Multiple products from internationally recognized companies including Roche Diagnostics, FUJIFILM, Siemens Healthineers, and Cepheid also completed renewal registrations.

Effective November 1, 2022, applicants can log in to the NMPA Government Service Portal's corporate workspace to view electronic certificates and print them as needed. This latest release of approval certificates once again demonstrates the NMPA's continued commitment to advancing medical device review and approval system reforms and accelerating the market entry of innovative products.