NMPA Approves 323 Medical Devices in July 2026

On August 19, 2026, China’s National Medical Products Administration officially released its monthly approval bulletin for medical devices (Announcement No. 77 of 2026). A total of 323 medical device products received regulatory approval in July 2026.

Here’s the breakdown:

l 275 domestic Class III medical devices

l 23 imported Class III medical devices

l 22 imported Class II medical devices

l 3 medical devices from Hong Kong, Macao, and Taiwan

Notable approvals across key therapeutic areas:

In the cardiovascular and neurovascular space, the list includes an intracranial stent (XinKaiNuo Medical), a balloon-occlusion microcatheter (Anhui WeiDian), a coronary balloon dilatation catheter (Yejie Medical), and a transcatheter aortic valve system (KeKai Life Sciences). The neurology segment saw approvals for a stereotactic puncture needle (Guangdong Anke Medical) and an implantable cardioverter defibrillator (Suzhou WuShuang Medical).

For surgical and energy-based devices, the bulletin features multiple ultrasonic soft tissue surgical devices (Shanghai ShengZhe Medical, Xinhua Surgical Instruments), plasma surgical systems (Hefei NuoErDe Medical), and a pulsed field ablation system for cardiac applications (Shenzhen BeiXin Medical).

In diagnostics, newly approved tests include a Group A Streptococcus (GAS) nucleic acid detection kit (ShengXiang Bio), a human CYP2C9 and VKORC1 genotyping kit (DaAn Gene), and a multiplex respiratory pathogen panel covering influenza A, influenza B, and Mycoplasma pneumoniae (BoErCheng).

The orthopedics and dental category features an additively manufactured acetabular pad (Chongqing YunSheng Bio), a soft tissue-level implant system (SiMaiYingTu Medical), and multiple dental implant systems.

On the imaging and software front, new additions include a SPECT/CT system (Shanghai GuangMai Medical), a color Doppler ultrasound diagnostic system (Wuhan United Imaging), and an MRI system (Shanghai United Imaging).

Regenerative medicine and aesthetic devices also saw activity, with approvals for a cross-linked collagen implant (Beijing AiBaiRui Bio), an injectable sodium hyaluronate solution (RunHui Bio), and a polylactic acid facial filler (imported).