China's Innovative Medical Devices Reach New Milestone: Two Products Approved on the Same Day

On September 28, 2026, China's National Medical Products Administration approved the registration applications for two innovative medical device products.

Product 1: Paclitaxel Drug-Coated Intracranial Balloon Dilatation Catheter

The "Paclitaxel Drug-Coated Intracranial Balloon Dilatation Catheter" by B. Braun Medical (Suzhou) Co., Ltd. has been approved. The product consists of a balloon and a catheter, with the balloon surface coated with paclitaxel. During balloon expansion, the drug coating is precisely released and transferred into the vessel wall, where paclitaxel is absorbed by intimal cells to inhibit excessive neointimal hyperplasia. Importantly, no permanent implant is introduced during the procedure. The product is indicated for interventional treatment of patients with symptomatic severe intracranial atherosclerotic stenosis who have failed medical therapy.

Notably, the product employs a proprietary precision-quantified coating technology and a tapered reinforced delivery catheter design, enabling rapid navigation through tortuous intracranial vessels while uniformly releasing paclitaxel to the lesion site during expansion. The "no-implant" treatment concept not only preserves future treatment options for patients but also helps reduce the burden of long-term antiplatelet therapy. Peijia Medical's subsidiary Shanghai Jiaqi Biotechnology (Suzhou) Co., Ltd. has secured exclusive distribution rights for mainland China, further expanding its neurointerventional product portfolio.

Product 2: Neonatal TREC/KREC Gene Detection Kit (Fluorescence PCR Method)

The "Neonatal TREC/KREC Gene Detection Kit (Fluorescence PCR Method)" by Shanghai Jieyi Biotechnology Co., Ltd. has been approved. Using multiplex fluorescence quantitative PCR technology, the kit is designed for in vitro qualitative detection of the relative copy numbers of TREC and KREC genes in dried blood spot samples, enabling screening for severe combined immunodeficiency (SCID) in newborns.

This is the first domestically developed product for screening SCID — a rare subtype of primary combined immunodeficiency — and is expected to facilitate early clinical intervention for newborns with SCID. For infants with SCID, hematopoietic stem cell transplantation performed within the first 3 months of life can achieve a survival rate exceeding 95%, underscoring the critical clinical value of newborn screening in improving outcomes.

Industry Context

As of August 2026, a cumulative total of 442 innovative medical devices have been approved in China. In the first half of 2026 alone, the NMPA approved 42 innovative medical devices, reflecting an accelerating trend of high-end innovative devices reaching the market. Regulatory authorities will strengthen post-market surveillance of these products to ensure patient safety.