Weekly Medical Device News Roundup (Aug 31 - Sep 6): Funding, Approvals, Regulatory Updates, and Strategic Collaborations

From September 1 to 3, 2026, the Center for Medical Device Evaluation of the National Medical Products Administration (NMPA) released the "Public Notice on Review Results of Applications for Special Review of Innovative Medical Devices (No. 14, 2026)," proposing to approve 11 products for entry into the special review procedure. These include Hunan Yiwedi's Disposable Steep Pulse Ablation Electrode Needle, Beijing BaiRen Medical's Aortic Root Patch, Shenzhen Jianxin Medical's Aortic Valve Replacement System, and Shenzhen Boruijie's 3D-Printed Breast Reconstruction Tissue Engineering Scaffold, among others. The special review procedure for innovative medical devices serves as a "green channel" for high-end domestically produced medical devices, significantly accelerating the evaluation process.

From September 1 to 3, 2026, the Center for Medical Device Evaluation of the National Medical Products Administration released the "Public Notice on the Review Results of Priority Approval Applications for Medical Devices (No. 17 of 2026)," proposing to include the Shenzhen Huiyun Biological Direct Bilirubin Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry), Guangzhou Anbiping Claudin18.2 Antibody Reagent (Immunohistochemistry), and Wenzhou Puxi Gene Leber Hereditary Optic Neuropathy Genetic Testing Kit (PCR-Fluorescent Probe Method) in the priority approval process. The reasons are, respectively, significant clinical advantages in the diagnosis of rare diseases, urgent clinical need, and no domestically registered products of the same variety having been approved.

This week in 2026, Shenzhen Boruijie Medical’s “3D-Printed Tissue Engineering Scaffold for Breast Reconstruction” was approved to enter the National Innovative Medical Device Special Review Procedure. Addressing the challenge of filling and repairing defects following breast-conserving surgery for breast cancer, the product is flexible, biodegradable, and highly porous, capable of inducing cell ingrowth and soft tissue regeneration after implantation. Boruijie Medical specializes in the research and development of 3D-printed tissue engineering scaffolds. Its core technology stems from the commercialization of achievements by the team of Professors Li Dicheng and He Jiankang from the School of Mechanical Engineering at Xi’an Jiaotong University. The company has been included in the list of key service projects of the Greater Bay Area Sub-center of the Center for Medical Device Evaluation.

On September 2, 2026, the Tianjin Municipal Medical Products Administration published the list for the review and recognition of Class II innovative medical devices (2026, Issue No. 4). The "Near-Visual Function Training and Treatment Software" developed by Tianjin Shiyu Technology Co., Ltd. is proposed to enter the special review procedure, with a public notice period from September 3 to September 16, 2026. During the same period, Sichuan Gongwu Chuangzhi's "Medical Sterile Interventional Radiation Protection Gloves" were included in Sichuan Province's special approval procedure for Class II innovative medical devices. These gloves are the world's first ultra-thin medical radiation protection gloves with variable wall thickness.

On August 31, 2026, the National Medical Products Administration (NMPA) approved two Class III in vitro diagnostic (IVD) reagents for pathogen metagenomic next-generation sequencing (mNGS): Guangzhou Weiyuan Medicine’s “Respiratory Pathogen Nucleic Acid Detection Kit (Joint Probe-Anchored Polymerase Sequencing Method)” (National Medical Device Registration No. 20263401813), used for the auxiliary diagnosis of suspected severe and critical lower respiratory tract infections, immunodeficient cases, and difficult-to-diagnose cases, marking it as the world’s first mNGS-based reagent for respiratory pathogen detection; and Tianjin Jinshi Medicine’s “Bloodstream Infection Pathogen Nucleic Acid Detection Kit (Reversible Terminator Sequencing Method)” (National Medical Device Registration No. 20263401810), the first mNGS reagent for bloodstream infections in China. Both companies are representative enterprises in the field of precision infectious disease diagnostics, signifying the transition of mNGS from the Laboratory Developed Test (LDT) model to the standardized IVD era.

On August 31, 2026, the National Medical Products Administration (NMPA) approved the Class III medical device registration certificate for Sichuan Dachuan Heyi’s “Gelatin Sponge Embolic Microspheres” (Registration No.: Guo Xie Zhu Zhun 20263131783, valid until August 23, 2031). The product is indicated for embolization therapy in adults with primary hepatocellular carcinoma and for palliative treatment of renal tumors, representing the first truly uniform biodegradable embolic microspheres in China. Dachuan Heyi specializes in the research and development of interventional embolization materials; the approval of this product marks the first industrial application of droplet microfluidics technology in the interventional field in China.

On September 2, 2026, the force-feedback laparoscopic surgical robot, jointly developed by Professor Song Aiguo’s team at Southeast University and Nanjing Tuodao Medical Technology, successfully completed two partial nephrectomies and one radical prostatectomy (with a total duration of 1 hour and 9 minutes) in collaboration with the urology teams at the First Affiliated Hospital of Zhengzhou University and the First Affiliated Hospital of Xinjiang Medical University, spanning a distance of 2,400 kilometers. This marks the first domestic laparoscopic robot with force-feedback technology to achieve clinical implementation in China. Tuodao Medical focuses on the localization of laparoscopic surgical robots. The team has achieved multi-dimensional force sensing within an instrument shaft less than 9 millimeters in diameter, filling the technological gap in force sensing for domestically produced laparoscopic surgical robots and creating a dual "visual + tactile" sensing system in conjunction with 3D 4K fluorescence endoscopy.

On September 4, 2026, media reports stated that Hu Hao, Chief Physician of the Urology Department at Peking University People’s Hospital, remotely operated a domestically produced surgical robot from Beijing to perform a radical nephroureterectomy for renal pelvic cancer on a 70-year-old patient at Qingyuan People’s Hospital in Guangdong Province, more than 2,000 kilometers away. The two-way transmission latency between the two locations remained stable at 42 milliseconds. The surgery lasted less than two hours, with minimal intraoperative blood loss. The patient was able to get out of bed and drink water on the second day postoperatively. The hospital’s Urology Department has long been dedicated to advancing minimally invasive surgical robot technology. This procedure marks a shift in remote robotic surgery from single-point technical validation to cross-provincial, multi-center, and multi-specialty clinical exploration.

On August 31, 2026, the National Healthcare Security Administration issued the "DRG Payment Grouping Scheme Version 3.0" and the "DIP Payment Grouping Scheme Version 3.0" (Document No. 22 [2026] of the National Healthcare Security Administration). The number of Diagnosis-Related Group (DRG) core groups (ADRGs) was expanded to 492, with 825 subgroups (DRGs). The DIP core disease catalog was expanded to 5,125 entries, increasing case coverage from 92% to 95%. Among the six major changes, the scheme explicitly introduced the principle of "same payment for the same disease" for primary care conditions to guide tiered diagnosis and treatment, and added new grouping categories for robot-assisted surgical procedures for the first time, thereby directing medical insurance payments toward high-value innovative medical devices.

On September 1, 2026, the Center for Medical Device Evaluation of the National Medical Products Administration (NMPA) released draft guidelines for public comment on 55 registration review guidance documents for Class II passive medical devices (Batch II), including the “Guiding Principles for the Registration Review of Protective Products for Radioactive Seed Implantation (Draft for Comment).” These guidelines cover subcategories such as surgical staplers, implantable drug delivery devices, single-use drainage tubes, medical dressings, plastic surgery implants, and orthopedic consumables. The deadline for submitting feedback is October 8, 2026. This batch extends the initial 50 items issued in 2024, with a strengthened focus on biocompatibility evaluation of passive devices, traceability of raw material supply chains, and the integrity of production process validation data.

On August 31, 2026, the National Medical Products Administration (NMPA) convened a meeting in Beijing to promote the translation of clinical research achievements for medical devices and advance the “Spring Rain Action.” Lei Ping, a member of the Party Leadership Group and Deputy Director of the NMPA, attended and delivered remarks. He summarized the phased achievements of the “Spring Rain Action” and outlined four key priorities for the next stage: securing “source water” by deeply exploring genuine clinical needs; fostering vertical integration to break down barriers between medical and engineering sectors; leveraging demonstration projects to unleash policy vitality; and enhancing inter-departmental coordination to streamline the entire chain from clinical research through technological iteration to the implementation of results. Representatives from 17 provincial-level drug regulatory administrations, medical institution researchers, and industry stakeholders participated in the meeting.

This Week in 2026, the National Medical Products Administration Issued Two Announcements Deciding to Suspend the Import, Distribution, and Use of Three Products from US-based Avinger Inc. (Single-use Peripheral Vascular Plaque Excision Catheters, Registration Certificate Nos. Guo Xie Zhu Jin 20263010082 and Guo Xie Zhu Jin 20253010610; Intravascular Optical Coherence Tomography and Power Control Equipment, Registration Certificate No. Guo Xie Zhu Jin 20263010131) and One Product from Aaron Optical Instrument Co., Ltd. (Ophthalmic Surgical Knife, Registration Certificate No. Guo Xie Zhu Xu 20252160016).