Recently,"Iron Tycoon" Sun Jimu Acquires ZhenDe Medical with a 3.56 Billion Yuan Stake, Stock Price Surges Ahead of Announcement; Accumulated Increase Reaches 41.26% in Five Trading Days, Hitting a Two-Year High. Meanwhile, ZhenDe Medical's Controlling Shareholder, Zhejiang ZhenDe Holding Co., Ltd., and Its Wholly-Owned Subsidiary, Xuchang ZhenDe Landscape Engineering Co., Ltd., Plan to Fully Liquidate Their Holdings Through This Transfer. Xuchang Landscape’s Previous Reduction Plan Was Unexpectedly Terminated.Triggered the market's deep attention to capital game. Sun Jimu's cross-border move reflects both the migration of capital from the steel industry to high-growth sectors and highlights the strategic value of Zhende Medical in the healthcare track. Despite short-term profit pressure, the company’s overseas expansion and omnichannel marketing strategy may lay a foundation for long-term growth.

Recently, according to Bloomberg, Mindray has officially launched its preparatory work and selected Huatai Securities and JPMorgan Chase as underwriters to assist in advancing the relevant listing matters. Sources revealed that in the future, Mindray Medical may consider adding more international investment banks to the underwriting team based on progress to ensure global investor coverage. Previously, Bloomberg reported that Mindray Medical, a leader in A-share medical devices, was working with a potential advisory team to advance plans for a secondary listing in Hong Kong, with an expected fundraising size of no less than US$1 billion (approximately HK$7.8 billion). Founded in Shenzhen in 1991, Mindray Medical’s main products cover three major areas: life information and support, in vitro diagnostics, and medical imaging, providing global medical institutions with one-stop high-quality products and IT integrated solutions.

Recently, Elutia, a pioneer in drug-eluting bio-matrix technology, announced that it has reached a definitive agreement to sell its EluPro and CanGaroo bioenvelopes to Boston Scientific for $88 million in cash. According to Nasdaq data, Boston Scientific, with a current market capitalization of $160 billion, is a leader in the medical device and supplies industry, with its stock price near its 52-week high of $108.94. The bioenvelopes are designed to protect patients receiving implantable medical devices. Elutia stated that this transaction highlights the value of its proprietary drug-eluting biotechnology platform and allows it to complete the development and commercialization of its key product pipeline without equity dilution.

Recently, Zhejiang Province, in accordance with the national pilot program for deepening the reform of medical service pricing, and based on the "Pilot Program for Deepening the Reform of Medical Service Pricing" issued by the National Healthcare Security Administration and seven other ministries, as well as the "Zhejiang Province Pilot Implementation Plan for Deepening the Reform of Medical Service Pricing" issued by the provincial healthcare security bureau and seven other departments, has formulated a dynamic adjustment plan. In line with the requirements of the national reform pilot, Zhejiang Province has preliminarily established a management system featuring "total volume control, project management, category-based formation, tiered pricing, dynamic adjustment, and comprehensive governance." The healthcare security bureaus of each prefecture-level city and public medical institutions at all levels must fully recognize the importance of the reform, strengthen standardized management of medical service pricing, and ensure the steady and orderly advancement of the pilot work. The prices of projects reflecting the value of medical technical labor will be increased, while those mainly involving equipment and material consumption will be reduced. A total of 267 medical service prices have been adjusted (see attachment), among which nursing and obstetrics-related items are newly implemented according to the guidelines, following the relevant requirements of the "Notice of the Zhejiang Provincial Healthcare Security Bureau on Publishing Medical Service Price Items and Health Insurance Payment Policies for Obstetrics, Nursing, and Two Other Categories." Provincial public hospitals in Hangzhou will follow the above regulations, while other provincial public hospitals will adhere to the local medical service pricing policies.

Recently, the "Action Plan for Promoting the Full-chain Development of High-end Medical Device Industry in Shanghai," issued by the General Office of the Shanghai Municipal Government, has been made publicly available online. The Action Plan proposes development goals in three aspects: innovative products, leading enterprises, and industrial layout. It aims that by 2027, over 500 new domestic Class III medical device registration certificates will be approved for the first time, and more than 100 medical device products will obtain approval in overseas markets; achieving two leading enterprises with international competitiveness and output value exceeding 10 billion yuan each; and building three high-end medical device industry clusters in Pudong, Minhang, and Jiading. The Action Plan proposes strengthening the capacity building of the Yangtze River Delta Sub-center of the National Medical Products Administration and municipal drug regulatory departments; promoting the implementation of reform policies and pilot projects, continuously advancing the local production in Shanghai of Class II and Class III imported medical devices for companies that have obtained import medical device registration certificates; exploring the preliminary use in Shanghai of medical devices already on the market abroad but not yet registered domestically; and enhancing the formulation of standards and specifications for innovative products, while carrying out in-depth standardization work in product areas such as brain-computer interfaces.

Recently, Guangdong Province has formulated measures to standardize the management of the directory for clinically urgently needed imported Hong Kong and Macao drugs and medical devices in the nine mainland cities of the Guangdong-Hong Kong-Macao Greater Bay Area. This aims to meet the pharmaceutical and medical device needs of residents in the Greater Bay Area while ensuring the safety of drug and device use. According to the "Guangdong Province Regulations on the Management of Imported Hong Kong and Macao Drugs and Medical Devices in the Nine Mainland Cities of the Greater Bay Area," the measures define clinically urgently needed imported Hong Kong and Macao drugs and medical devices as those that are urgently required for clinical use, have been marketed in Hong Kong and Macao, and are used by designated medical institutions in the nine mainland cities of the Greater Bay Area. Additionally, they include medical devices that have been procured and used by public hospitals in Hong Kong and Macao, which are clinically advanced and urgently needed. The marketing authorization holders of drugs and medical devices or their authorized corporate entities within China can fill in the information of the proposed varieties to be included in the urgent review scope of Hong Kong and Macao drugs and devices according to requirements, and upload relevant materials. Once the variety information is successfully submitted, it will be included in the preliminary review database.

Recently, the Heilongjiang Provincial Drug Administration, in order to thoroughly implement the spirit of the Third Plenary Session of the 20th Central Committee of the Communist Party, and to implement the requirements of the "Opinions of the General Office of the State Council on Comprehensively Deepening the Reform of Drug and Medical Device Supervision to Promote High-Quality Development of the Pharmaceutical Industry" (Guo Ban Fa [2024] No. 53), has formulated support measures. The "Heilongjiang Province Medical Device Registration Quality Management System Verification Guidelines for Exemption from On-site Inspection" was developed. For eligible registration products, on-site inspection items will be optimized and reduced, with verification focusing only on the authenticity of the R&D process, production process, and testing process of products used for testing and clinical trials. When Class II imported medical devices are relocated to Heilongjiang Province, clinical evaluation materials and other registration application materials can be submitted according to the original registration application materials as stipulated in the "Announcement of the National Medical Products Administration on Matters Related to the Production of Imported Medical Devices by Enterprises within China." A green channel for inspection will be established for innovative drugs and innovative medical devices. For innovative drugs and innovative medical devices urgently needed in clinical settings, an immediate submission and immediate inspection policy will be implemented. If necessary, inspections may follow emergency inspection procedures in accordance with laws and regulations, compressing the inspection time to the shortest possible duration.

Recently, the Beijing Municipal Medical Products Administration, in collaboration with the Changping District People's Government, held a specialized training session on the registration and technical evaluation requirements for artificial intelligence medical devices. This initiative aims to address evaluation challenges faced by relevant entities in China’s medical device industry and promote innovation in “artificial intelligence + healthcare.” It was announced at the event that Beijing has cumulatively approved 52 Class III artificial intelligence medical device products, covering cutting-edge fields such as medical imaging-assisted diagnostics, surgical planning simulations, pathological analysis, and intelligent rehabilitation. To maintain its leading position, Beijing will continue to deepen the concept of "service-oriented regulation" and transform the evaluation model from "post-approval" to one that emphasizes "pre-guidance, mid-process service, and post-tracking." Mechanisms such as establishing a large model for medical device registration evaluations and implementing project-based management services will provide companies with more precise, efficient, and transparent evaluation services, effectively achieving the goal of "letting data do the running so companies don’t have to."

Recently, the Guangdong Provincial Drug Trading Center released the "Notice on the Public Disclosure of the Proposed Winning Results for the Renewal Procurement of Cardiac Pacemakers and Surgical Staplers under the Centralized Volume-based Procurement Agreement." According to the previously announced procurement documents, this renewal procurement conducted by Guangdong Province covers the centralized volume-based procurement of cardiac pacemakers, disposable laparoscopic trocars, end-to-end anastomosis devices, and hemorrhoid staplers. Among these, the cardiac pacemaker category excludes temporary leads and subcutaneous defibrillation leads; the disposable laparoscopic trocar category excludes single-port multi-channel trocars. In this renewal procurement, the centralized procurement of cardiac pacemaker-related consumables covers four provinces: Guangdong, Hubei, Jiangxi, and Guizhou, with Guizhou not participating in the procurement of dual-chamber pacemakers. The procurement scope for disposable laparoscopic trocars, end-to-end anastomosis devices, and hemorrhoid staplers is limited to Guangdong Province.

Recently, the National Medical Products Administration approved and released the YY/T 1987—2025 "Terminology for Medical Devices Using Brain-Computer Interface Technology" medical device industry standard. This is the first brain-computer interface medical device standard in China, laying the foundation for the high-quality development of the brain-computer interface medical device industry.