NMPA Issues 7 Technical Review Reports for Class III Medical Devices

On August 5, 2026, the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration publicly released seven Class III medical device technical review reports.

The reviewed products include:

l Trifocal Intraocular Lens – Applicant: Henan Semishine Biotechnology Co., Ltd. Indicated for vision correction in adult cataract patients to improve near, intermediate, and distance vision while reducing glasses dependence.

l Steerable Pulmonary Artery Thrombus Removal Stent System – Applicant: Shanghai XuanYu Medical Devices Co., Ltd. Indicated for catheter-based thrombus clearance treatment in acute high-risk pulmonary embolism or clinically deteriorating intermediate-risk pulmonary embolism.

l Self-Expanding Single-Rivet Biodegradable Atrial Septal Defect Occluder – Applicant: Shanghai JinKui Medical Equipment Co., Ltd. Indicated for occlusion treatment of congenital heart disease secundum atrial septal defect (ASD).

l Intravascular Ultrasound Diagnostic Device & Disposable Intravascular Ultrasound Diagnostic Catheter – Applicant: Shenzhen Haoying Medical Technology Co., Ltd. Used in conjunction for coronary ultrasound imaging in patients undergoing vascular interventional therapy.

l Endovascular Stent – Applicant: Shanghai Qigong Medical Technology Co., Ltd. Indicated for patients with residual type B aortic dissection after Sun's procedure for Stanford type A dissection and after covered stent surgery for Stanford type B dissection.

l Disposable Central Venous Catheter and Kit – Applicant: Henan Tuoren Medical Device Group Co., Ltd. Indicated for intravenous infusion, venous pressure measurement, and intravenous nutritional therapy.

l Treponema Pallidum Antibody Detection Kit (Colloidal Gold Method) – Applicant: Nanjing Shenji Pharmaceutical Technology Co., Ltd. Indicated for in vitro qualitative detection of TP antibodies in human serum, plasma, whole blood, or fingertip blood samples. Fingertip blood can be used for consumer self-testing.

These published review reports provide valuable insights into the regulatory evaluation standards for complex Class III devices and serve as important references for manufacturers preparing similar product registration applications.