NMPA Newly Approved Medical Device List: Distal Embolic Protection System, High-frequency Surgical System, and Multiple Innovative Products Granted Certificates

On August 21, 2026, the National Medical Products Administration officially released its weekly delivery information for medical device approval certificates, covering a total of 74 products that received regulatory clearance. This batch reflects a broad spectrum of device categories, ranging from infusion sets and wound dressings to orthopedic implants, surgical systems, in vitro diagnostic reagents, and dental materials. The approvals were issued on various dates between August 17 and August 20, with the majority bearing the effective date of August 18, 2026. As per the NMPA’s practice since November 1, 2022, all applicants can now access their electronic certificates through the legal entity portal of the NMPA Government Service Platform and print them as needed.

Among the domestic approvals, notable items include disposable infusion sets with needles from Sichuan New Century Medical Polymer Products, foam dressings from Jiangsu Chuangming Medical Devices, patellar rings from Tianjin Weiman Biomaterials, and distal embolic protection systems from Hunan Epit Medical Devices. Orthopedic products such as metal bone pins, straight bone plates, and spinal anterior fixation plates also received renewals, along with high-frequency surgical systems and hydroxyapatite bioceramics. In the IVD segment, key clearances went to hepatitis B pre-S2 antigen test kits, intestinal adenovirus antigen rapid tests, alpha-fetoprotein chemiluminescence kits, Toxoplasma IgM ELISA kits, ALDH2 gene detection kits, and ABO/RhD blood grouping cards, reflecting ongoing strength in domestic diagnostic manufacturing.

For imported devices, the approved list includes peripheral stent systems from Abbott Medical, ophthalmic diagnostic instruments from Nidek, real-time PCR systems from Roche Molecular Systems, and balloon-expandable covered stents from Clearstream Technologies. Other significant imports are locking plates from Synthes, calcium alginate dressings from Paul Hartmann, radiofrequency ablation systems from Biosense Webster, Nd:YAG picosecond lasers from Candela, and mobile C-arm X‑ray systems from Philips. Additionally, several new products received their initial approvals this week, such as collagen implants, continuous glucose monitoring systems, facial resorbable threads, delivery catheters, and plasma virus inactivation devices, underscoring the continued pace of innovation in China’s medical device sector.

All approval details are published on the NMPA official website, and the complete list can be accessed via the link provided. This regular update serves as a valuable reference for industry professionals tracking regulatory trends and competitive landscapes in the Chinese healthcare market.