Haihe Outlook | Medical Device Regulatory News Weekly Report (April 20–24, 2026)
Shenqi Medical
Cardiovascular Interventional Device Developer
Sunnyou
Intelligent Rehabilitation Equipment R&D and Manufacturer
Horimed
OCT Imaging Equipment R&D and Manufacturer
1.NMPA Announcement on the Cancellation of Registration Certificates for Artificial Crystals and 3 Other Medical Devices (No. 39, 2026)
In accordance with the relevant provisions of the Regulations on the Supervision and Administration of Medical Devices, and based on the enterprise's application, the National Medical Products Administration has canceled the medical device registration certificates for a total of four products from the following two companies.
News Link:
https://www.nmpa.gov.cn/xxgk/ggtg/ylqxggtg/ylqxqtggtg/20260420170225143.html
2.1 IVD Sequencing ProductEnter the Expedited Review Process for Medical Devices
On April 22, CMDE announced the review results of priority approval, and one IVD sequencing product was approved to enter the priority approval process for medical devices.
News Link:https://www.cmde.org.cn/xwdt/shpgzgg/cxyxgsh/20260422161107198.html
3. Transcatheter Mitral Valve Clip System Approved for Marketing
Recently, the National Medical Products Administration approved the innovative product registration application for the "Transcatheter Mitral Valve Clip System" by Shanghai Shenqi Medical Technology Co., Ltd.
https://www.nmpa.gov.cn/zhuanti/cxylqx/cxylqxlm/20260422093337118.html
Industry News
1.GE Healthcare's First "Black Light" Demonstration Production Line Launched in Beijing Yizhuang
On April 21, during the 35th anniversary of the GE Healthcare Beijing Manufacturing Base (hereinafter referred to as "Beijing Base"), GE Healthcare officially launched its first end-to-end, intelligent CT detector "dark factory" demonstration production line, leading to another leap in the level of smart manufacturing for high-end medical devices in China.
2. Brain-Computer Interface Rehabilitation Equipment Technology Innovation Center of Henan Province Unveiled in Anyang
On April 18, the Henan Brain-Computer Interface Rehabilitation Equipment Technology Innovation Center was officially inaugurated in Anyang. This center is the first provincial-level brain-computer interface technology innovation platform approved for construction in China. Led by Xiangyu Medical Co., Ltd. ("Sunnyou"), it was jointly built with Zhengzhou University and the First Affiliated Hospital of Zhengzhou University.
https://www.henan.gov.cn/2026/04-23/3345066.html
Market and Capital Dynamics
1. Horimed Secures Over 100 Million Yuan in Financing to Build a Three-Dimensional Integrated Platform of "Intraluminal Imaging + Cardiac Ultrasound All-in-One Machine + Laser Ablation"
Recently, Horimed Technology Co., Ltd. ("Horimed Medical") announced the completion of a financing round exceeding 100 million yuan. This round was led by CICC Capital and Xichuang Investment, with existing shareholder Chengdu Sci-Tech Investment adding further investment. StarBridge Capital served as the long-term exclusive financial advisor. This significant financing, completed by Horimed Medical in early 2026, will help accelerate the company’s R&D, production, and commercialization of intravascular interventional imaging and treatment-related products.
https://mp.weixin.qq.com/s/tetm-DBcbGeI7af6HwKvlA
2. Innary Medical Completes Tens of Millions in Financing! Lingang Pioneer Fund and Shell Fund Jointly Invest, WEGO Empowers Industry, Accelerating China-Made Substitution in Bone Metabolism Diagnosis and Treatment
Innary Medical Technology (Shanghai) Co., Ltd. recently successfully completed a multi-million-level financing round. This round of financing was jointly invested by Shanghai Lingang Guotai Haitong Qihang Venture Capital Partnership (Limited Partnership) ("Lingang Qihang Fund") and Hangzhou Jushangjian Venture Capital Investment Partnership (Limited Partnership) ("Beike Fund"), a fund under Beike She. Weigao Group deeply participated through the Beike Fund, providing full-chain industrial empowerment for Innary Medical.
https://mp.weixin.qq.com/s/04t5ybNXi93DxKPsemEkcw
3. Over 100 Million Yuan in Series A Financing! Aoming Xingcheng Defines Next-Generation Bio-Intelligence Infrastructure with AI4S, Empowering Industrial Chain Upgrading with a New Paradigm
Recently, Aoming Star Cheng (Shenzhen) Biotechnology Co., Ltd. (hereinafter referred to as "Aoming Star Cheng") announced the completion of an over RMB 100 million Series A round of financing. Following the Pre-A round, the company achieved a more than fivefold increase in financing scale within one year.
Haihe Biotech is a platform company that professionally provides full lifecycle services for products to research institutions, R&D and manufacturing enterprises related to medical devices and pharmaceuticals, as well as relevant regulatory authorities. It holds an extremely high position in the biopharmaceutical CRO field. Haihe Biotech’s businesses cover full lifecycle services, service-oriented manufacturing, intelligent manufacturing, and third-party testing and certification, which are highly aligned with China's "14th Five-Year Plan."
Engaged in standardized and customized testing and monitoring services for medical devices, pharmaceuticals, combination products, and biopharmaceutical environments. Possesses relevant qualifications aligned with domestic and international advanced testing standards, enabling a single test to meet the requirements of different regions and markets.
Providing customers with full lifecycle regulatory policy consultation, registration certification guidance, post-market adverse event handling, technology transfer, training, and related services for medical devices, pharmaceuticals, and combination products in regions such as China, the United States, the European Union, Brazil, Canada, and Southeast Asian countries.
Haihe Biotechnology's Medical Device Contract Development and Manufacturing Platform is established in accordance with China's NMPA Good Manufacturing Practice for Medical Devices, the U.S. FDA's QSR, and ISO13485 standards. The platform serves medical device industry-academia research, medical-engineering translation, and startup teams by undertaking custom medical device product development, outsourced R&D, and outsourced production. Its manufacturing capabilities cover IVD diagnostic reagents, IVD diagnostic equipment, medical devices, and high-value surgical consumables.
