On January 21, 2025, the NMPA announced the results of the special review for innovative medical device applications (No. 1, 2025), with 9 products entering the innovation channel.
1. Product Name: Decellularized Conjunctival MatrixApplicant: BioDcell (Chengdu) Biotechnology Co., Ltd.BioDCell (Chengdu) Biotechnology Co., Ltd.One companyA high-tech enterprise focusing on the R&D and application of tissue engineering and regenerative medicine technologies。The company is dedicated to the research, development, and application of technologies, equipment, and products related to decellularized biological tissues and organs, stem cell recellularization, as well as the research and development of innovative drugs and biological products.2. Product Name: Surgical Biological PatchApplicant: Zhuo Ruan Medical Technology (Suzhou) Co., Ltd.
ZhuoRuan Medical is a high-tech enterprise dedicated to the research and development and application of new materials in regenerative medicine. It holds the exclusive core technology of advanced biomaterials for basement membranes in China. The company has built modern regenerative medicine R&D centers in Shanghai and Taicang, and owns the largest production base for extracellular matrix raw materials in China, along with automated production lines and testing laboratories.More than twenty Class III implantable medical device products based on basement membrane platform technology have been developed, covering application areas such as hernia and abdominal wall surgery, neurosurgery, dermatology, gynecology, otorhinolaryngology, and orthopedics.Among them, the Antisheng biological hernia mesh and Anruisheng dura (spinal) mater patch have been successively approved for marketing.The company has obtained two National Innovative Medical Device Approvals.It has successively been awarded as a National High-tech Enterprise, a Potential Unicorn Enterprise in Jiangsu Province, and a Jiangsu Province Double Innovation Talent Enterprise, etc., with 36 national invention patents applied for and authorized, 5 international patents, and has undertaken research projects such as the National Natural Science Foundation of China, National Defense Science and Technology, and sub-projects of the National Key R&D Program.The company has currently established research and development centers in Shanghai and Taicang, with a planned production base for basement membrane materials and high-value medical device consumables exceeding 5,000 square meters, and the R&D center occupying over 2,000 square meters.3. Product Name: Glaucoma Drainage DeviceApplicant: Suzhou Purevision Medical Technology Co., LTD
Purevision Medical is committed to building a globally leading innovative ophthalmic minimally invasive treatment platform, and has successively been awarded honors such as "Jiangsu Province Double Innovation Talent Enterprise," "Jiangsu Province Potential Unicorn Enterprise," and "National High-tech Enterprise." It has also received special support from the Jiangsu Provincial Department of Science and Technology for the transformation of scientific and technological achievements.Independently developed by the companyChina-Originated Glaucoma Treatment Stent Product AqueFish®It is a minimally invasive glaucoma surgical instrument that represents an original innovation by Chinese doctors. It is also one of the few stent products in the world that can be used for both angle-closure glaucoma and open-angle glaucoma, bringing more possibilities to glaucoma treatment. 4. Product Name: Metal Additive Manufacturing Interbody Fusion CageApplicant: Beijing Aikang Yicheng Medical Equipment Co., Ltd.Beijing Aikang Yicheng Medical Equipment Co., Ltd. was established in 2003, and isCore Subsidiary of Aikang MedicalAikang Yicheng has postdoctoral research workstations, Beijing Enterprise Technology Centers, Beijing Engineering Technology Research Centers, Beijing-level Enterprise Science and Technology Research and Development Institutions, Beijing Intelligent Manufacturing Benchmark Enterprises (Digital Workshop), and other national and provincial-level scientific and technological innovation platforms, as well as a CNAS-accredited testing center.
As of the end of 2022, AK MedicalMore than 600 patents granted in the United States, Europe, Japan, China, and other countries and regions; over 70 Class III product registration certificates approved by NMPA; more than 20 product registration certificates approved in the United States, Europe, and other countries and regions.；Successively obtainedThe world's first clinically validated 3D-printed orthopedic implant productClass III Registration Certificate,The World's First 3D-Printed Patient-Matched Orthopedic Implant ProductClass III Registration Certificate。
5. Product Name: Self-expanding Particle-loaded Portal Vein StentApplicant: Nanjing Rongsheng Medical Technology Co., Ltd.Nanjing Rongsheng Medical Technology Co., Ltd.("Purevision Medical" for short)Rongsheng Medical") was established in 2019 as a platform company focused on the field of precision internal radiation interventional therapy for tumors. Based on radioactive particle brachytherapy stent technology, the company has developed a series of stent products targeting different indications.Established in 2021Suzhou Rongsheng Medical Technology Co., LTD., and carry out the research, development, and production of particle stents. 6. Product Name: Continuous Needle-Free Drug Delivery SystemApplicant: Jiangsu Leju Pharmaceutical Technology Co., Ltd.Jiangsu Leju Pharmaceutical Technology Co., Ltd. is aCentered on "Precision Drug Delivery"A research-driven innovative enterprise, which has spent ten years honing its expertise in the field of needle-free transdermal drug delivery, continuously deepening its efforts, thereby achieving a leapfrog advancement.In the early 2000s, Jiangsu Leju's core R&D team introduced needle-free technology to China and began research in the Chinese medical field. The core principles of needle-free technology involve the comprehensive application of multiple disciplines, including clinical medicine, pharmaceuticals, immunology, tissue physiology, fluid mechanics, laser physics, and mechanical engineering. After extensive experimentation, Jiangsu Leju’s R&D team solidified the foundation for their needle-free injection technology. Finally, after sixteen years of accumulation, the team achieved breakthrough progress in basic device research, human vaccine immunity, human biopharmaceutical and chemical drug injections, and veterinary vaccine immunity. 7. Product Name: Intracranial Thrombectomy StentApplicant: Newvasc Medical Technology Co., Ltd.NeuroVasc Technologies was founded in California, USA, in 2015. Since its establishment, NeuroVasc Technologies has been committed to developingInnovative and Breakthrough Solutions for Neurovascular Diseases, focusing on the development of innovative catheter-based technology products to provide a wide range of treatment options for stroke and other neurological disease patients.The core product eNVi™-SR is a third-generation mechanical thrombectomy device designed for patients with acute ischemic stroke. Its unique segmented design remains open in tortuous vessels and complex anatomical structures, allowing for more effective clot capture. The product has received CE certification and undergone clinical trials in both China and the United States. 8. Product Name: Branched Intraoperative Stent SystemApplicant: Jiangsu Baiyouda Life Technology Co., Ltd.Jiangsu Baiyouda Life Technology Co., Ltd. was established in 2015 and currently has two production and R&D bases in Nantong and Shanghai.Since its establishment, Baiyouda has always focused on the research and development and production of high-end implantable and interventional medical devices, successively establishing wholly-owned subsidiaries Changdi and Baiheya. Its subsidiary includes VASOLINE.®Artificial Vessel, VASOPATH®Disposable Strap Retractor, MONOKNIT™Hernia Repair Patch, VASO™Non-absorbable surgical sutures and other products launched.9. Product Name: Biodegradable PFO OccluderApplicant: Worry-Free Heartbeat Medical Technology (Shenzhen) Co., Ltd.
Worry-Free Heartbeat Medical Technology (Shenzhen) Co., Ltd. was established on June 17, 2021, located in Shenzhen's National Biomedicine Innovation Industrial Park. It is an innovative enterprise focusing on the field of interventional treatment for heart diseases, especially structural heart disease. With the mission of "maximizing patients' quality of life and perfecting the last line of defense for life," the company adheres to the management philosophy of "innovation, collaboration, hard work, and win-win," and is committed to becoming the most innovative leader in cardiac medical devices within ten years.At this stage, the products are mainlyCentering on Patent Foramen Ovale (PFO), with the goal of being innovation-driven to provide a complete solution for PFO.The founding team has深耕 (deeply engaged) in the structural heart disease industry for more than ten years, being one of the earliest pioneers in China to focus on this field, accumulating rich market experience and expert resources.
# List of Award-Winning Medical Device Companies
Global Surgical Robotics Industry Awards 2024
Global Medical Technology Innovation Award 2024
Global MedTech Newcomer Award 2024
Global Innovation Medical Device Award 2024
# Overseas Large Medical Device Manufacturers
#ENMajor Medical Device Manufacturers in ChinaMindray Medical｜Lepu Medical|MicroPort Medical｜Weigao Group|United Imaging Healthcare
