China NMPA Releases Medical Device Approval List

The National Medical Products Administration (NMPA) released the latest Medical Device Approval Certificate Delivery Information on July 30, 2026. This batch covers a total of 128 medical device products, including 88 domestically manufactured items (registration numbers starting with “National Medical Device Registration”) and 40 imported items (“National Medical Device Registration”). Approval dates are concentrated on July 28–29, 2026, covering initial registrations, variations, and renewals.

Initial Registrations (46 items)

A total of 46 products received initial approval (application numbers starting with CQZ/CSZ/JQZ), of which 40 are domestic and 6 are imported. These span a wide range of high‑value medical equipment and innovative devices:

l Diagnostic Imaging: MRI systems (Shandong Xinyaoyi, Beijing Wandong), superconducting MRI, mobile C‑arm X‑ray (Shenzhen Baorun Technology), oral CBCT (Nanjing Ruide Medical Technology), etc.

l Surgical & Therapeutic Devices: Thoracoscopic/laparoscopic surgical robotic system (Wuhan United Imaging Intelligent), high‑frequency surgical equipment (Shaanxi Xishu Xinchuang, Jinan Xinbeixi), ultrasonic bone surgical device (Wuhan Mindray), blood purification devices (Weihai Weigao Artificial Liver, MediCare Medical), insulin pump (MicroTech Medical), etc.

l Cardiovascular & Interventional: Single‑use pulsed field ablation catheter (Shenzhen Beixin Medical Technology), star‑shaped mapping catheter (Aikemai Medical), intracranial pressure sensor kit (Jingmeide), etc.

l Surgical Navigation & Software: Intracranial aneurysm planning software (Kunming Tongxin Yilian), orthopedic navigation system (Nanjing Pu'ai Medical), radiotherapy contouring software (Guangzhou Baishi Medical), MR liver lesion assessment software (Shanghai United Imaging Intelligence), etc.

l IVD Reagents & Equipment: Chromosomal aneuploidy and CNV detection kit (Hangzhou Jieyi Maite), HPV genotyping kit (Shanghai ZJ Bio‑Tech), real‑time PCR analyzer (Suzhou Yarien Bio‑tech), gene sequencer (Suzhou Jiyinjia), etc.

l Imported initial registrations (6 items): Masimo pulse oximetry sensor, Carl Zeiss intraoperative confocal laser fluorescence imaging, KARL STORZ fluorescence exoscope, Integra ultrasonic aspirator accessories, POINTIMPLANT oral CBCT, and Bausch + Lomb ophthalmic surgical microscope.

Variations & Renewals (82 items)

A total of 82 products received variation (CQX/CSX/JQX) or renewal (CQY/JQY) approvals, with 48 domestic (17 variations, 31 renewals) and 34 imported (15 variations, 19 renewals). Representative products include:

l Variations: Radiofrequency ablation devices and electrode needles (MedSphere Medical), microwave therapy device (Xuzhou Shengpu Medical), ultrasonic soft tissue cutting device (Ansukang Medical), as well as IVD kits for influenza A/B (Beijing Zhuocheng Huisheng) and HIV antibody (Beijing Huashengyuan). Imported variations feature Medtronic microcatheter, ConMed electrosurgical unit, Boston Scientific DBS electrode, Ethicon non‑absorbable sutures, and 3M self‑adhesive resin cement.

l Renewals: A broad range of routine products such as infusion sets, IV catheters, absorbable interference screws, cranial reconstruction systems, metal bone screws, hemodialysis concentrate, bileaflet mechanical heart valves, foldable intraocular lenses, biologic hernia mesh, and interbody fusion cages, covering infusion, orthopedics, cardiovascular, ophthalmology, and hemodialysis fields.

Important Notice: As of November 1, 2022, applicants can log in to the NMPA Government Service Portal to view and print their electronic certificates independently.