Medical Device Industry Weekly Highlights (June 17–24, 2026): Funding Rounds, Product Approvals, and Regulatory Updates

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VHeartJ™ Intracranial Electrolytic Detachable Coil Approved for Marketing

A Powerful Tool for Thoracic Surgery: Shukun Technology's AI Preoperative Planning Product for Lungs Receives NMPA Class III Certification

Recently, the Market Supervision Administration of Baiyun District, Guangzhou issued a fine of over 190,000 yuan to a company named Shangpin International Beauty Technology (Guangzhou) Co., Ltd. for failing to provide the corresponding medical device product registration certificate for its beauty instrument products.

According to the penalty information provided by relevant departments, Shangpin Technology began producing the involved "Collagen PRO" beauty device in February 2024. The product mainly consists of radio frequency and microcurrent electrode pads, LED lights, temperature sensors, and a control panel. Moreover, based on the product manual, "Collagen PRO" features radio frequency and microcurrent functionalities. The Market Supervision Administration of Baiyun District, Guangzhou City determined that the aforementioned beauty device "Collagen PRO" should be managed as a Class III medical device. However, the company was unable to provide the corresponding registration certificate. Consequently, illegal earnings and assets were confiscated, and a fine was imposed, amounting to a total of 194,400 yuan.

Recently, Beijing Surgerii Robotics has collaborated with Haidian Hospital to achieve the commercial demonstration application of single-port surgical robots through government support, enhancing medical standards and accelerating the benefits of medical technology innovation for the public. Surgerii® Robotics will uphold the mission of "Innovating minimally invasive surgery, benefiting doctors and patients worldwide," providing exemplary application scenario services with the principle of "Life First" to safeguard the health and well-being of the people.

Recently, Zhiyu Healthcare has developed metaFlow®, China's first waterjet surgical robot, by breakthroughs in waterjet booster technology. This innovation standardizes and automates BPH surgeries, reducing operation time to 5 minutes and lowering the risk of complications. It has received multiple patents and global recognition, while also completing a new round of financing exceeding 60 million yuan.

Recently, the Shanghai Municipal Medical Products Administration released the "Notice on Doing a Good Job in the Third Batch of Implementation of Unique Device Identification for Medical Devices."

Requirements: Medical devices produced on or after June 1, 2024, must have a Unique Device Identification (UDI); previously produced products in the third batch of UDIs implementation may not have a UDI. The production date is subject to the medical device label. In cases where the product management category changes due to dynamic adjustments in the "Medical Device Classification Catalog," the registrant must implement the UDI according to the requirements of the adjusted management category. For applications submitted on or after June 1, 2024, the registration applicant must submit the product identifier of the smallest sales unit in the eRPS system; for applications accepted or approved before June 1, the registrant must submit the product identifier of the smallest sales unit in the eRPS system during product renewal or change registration.

Recently, the Device Supervision Department of the National Medical Products Administration held a meeting in Kunming to consolidate and enhance medical device safety.(Southern Region) Symposium.

The meeting heard reports from the drug regulatory authorities of 12 provincial-level regions—Yunnan, Shanghai, Jiangsu, Fujian, Jiangxi, Henan, Hubei, Hunan, Guangxi, Sichuan, Guizhou, and Tibet—on the progress of safety consolidation and enhancement efforts. It also studied and planned the key tasks for the next phase. The meeting required that each provincial bureau follow the action plan for safety consolidation and enhancement, strengthen the investigation and rectification of risk隐患 in key product categories such as those selected through centralized procurement and sterile implants, as well as key enterprises including registered persons engaged in contract manufacturing. Efforts should be made to enhance online monitoring and case handling, continuously advance the development of regulatory capabilities, and ensure the successful completion of key tasks throughout the year.

Recently, the General Office of the National Medical Products Administration issued a list of typical artificial intelligence application scenarios in drug regulation. The List outlines 15 leading and exemplary, promising, pain-point addressing, and urgently needed application scenarios. It aims to promote the research and exploration of artificial intelligence technology in the field of drug regulation, with the main goal of deep integration of artificial intelligence and drug regulation. The list standardizes and guides drug regulatory authorities at all levels in researching and applying artificial intelligence technology, focuses resources, and promotes artificial intelligence empowerment of the drug supervision system. It also provides reference and guidance for other research institutions, technology companies, and pharmaceutical enterprises in related research and applications. When carrying out artificial intelligence application practices, attention should also be paid to network security and data security issues to ensure the safe and robust application and development of artificial intelligence technology in the field of drug regulation.

Recently, the National Medical Products Administration released the "Measures for the Supervision and Inspection of Medical Device Clinical Trial Institutions (Trial)", to standardize the supervision and inspection work of medical device clinical trial institutions and strengthen the management of medical device clinical trials. The Measures will come into effect on October 1, 2024.

The "Measures" consist of six chapters and 43 articles, including General Provisions, Inspection Agencies and Personnel, Inspection Procedures, Coordination of Inspection-related Work, Handling of Inspection Results, and Supplementary Provisions. These apply to the inspection and handling by drug regulatory authorities of the record-filing of medical device clinical trial institutions (hereinafter referred to as trial institutions) and the implementation of medical device clinical trial quality management standards for clinical trials of medical devices (including in vitro diagnostic reagents) conducted for the purpose of medical device registration.

Recently, Xu Jinghe, member of the Party Leadership Group and Deputy Director of the National Medical Products Administration, organized a regulatory risk consultation meeting for medical devices in the second quarter of 2024. The meeting reported on the risk management situation of the first quarter. Relevant departments and directly affiliated units, as well as some provincial bureaus, conducted risk consultations regarding unannounced inspections, adverse event monitoring, online sales, complaints, reports, and public opinion monitoring of medical devices in the second quarter, analyzing the safety situation of medical devices. The meeting required that drug regulatory authorities at all levels strengthen the analysis of the safety situation of medical devices, carry out in-depth risk consultations, implement the concept of risk governance, enhance follow-up actions, and comprehensively address risk and hazard identification and mitigation. It is necessary to further enforce the main responsibilities of enterprises and the responsibilities of regulatory authorities, focus on prominent issues, improve risk prevention and control capabilities, continuously manage risks effectively, and ensure the quality and safety of medical devices.

Recently, in order to further standardize the management of medical devices such as Traditional Chinese Medicine (TCM) pulse diagnosis equipment, the Medical Device Review Center of the National Medical Products Administration has organized the formulation and revision of the "Guiding Principles for Registration Review of TCM Pulse Diagnosis Equipment" and 19 other guiding principles for medical device registration review. The products involved this time include a total of 20 products, including active, passive, and IVD items such as TCM pulse diagnosis equipment, sodium hyaluronate gel wound dressings, dental alloy materials, disposable vacuum blood collection tubes, negative pressure drainage devices, blood glucose meters, and albumin assay kits.

Recently, the Hunan Provincial Drug Administration announced that it, together with the Changsha Municipal Market Supervision Administration, organized spot checks on medical device products produced, operated, and used within their jurisdiction. A total of 23 batches (units) of medical devices were found to be non-compliant with standard regulations. These include 11 batches of medical protective masks/surgical protective masks, 1 batch of pulse oximeters, 1 batch of disposable medical protective clothing, and 10 batches of custom fixed prosthetic teeth, involving 21 enterprises. For example, the labeled manufacturers of non-compliant pulse oximeters and disposable medical protective clothing are Guangxi Kael Medical Technology Co., Ltd. and Henan Kaitai Medical Device Co., Ltd., respectively. The non-compliant items are signal integrity and sterility, respectively.

Recently, the Work Report on Compliance Governance of Medical Device Online Sales was held in Beijing. At the meeting, relevant departments of the National Medical Products Administration reported on recent online sales of medical devices, public opinion monitoring, and complaints and reports related to online medical devices.

Baidu, JD.com, Meituan, Pinduoduo, Douyin, Xiaohongshu, Taobao Tmall, Alibaba Health, Kuaishou, and other nine third-party platform companies introduced their work on carrying out compliance governance for the online sales of medical devices. The meeting required third-party platform companies and local regulatory authorities to effectively fulfill their responsibilities, make joint efforts, adhere to a problem-oriented approach, strengthen information notification and sharing, and ensure that any discovered problem leads are thoroughly investigated and handled in accordance with the law. This is to further purify the online market environment for medical device sales and ensure public safety in purchasing and using medical devices.

Recently, the National Medical Products Administration released the "Measures for the Supervision and Inspection of Medical Device Clinical Trial Institutions (Trial)", to standardize the supervision and inspection work of medical device clinical trial institutions and strengthen the management of medical device clinical trials.

The Measures will come into effect on October 1, 2024. The Measures consist of six chapters and 43 articles, including General Provisions, Inspection Agencies and Personnel, Inspection Procedures, Coordination of Related Inspection Work, Handling of Inspection Results, and Supplementary Provisions. These apply to the inspection and handling by drug regulatory authorities of the filing of medical device clinical trial institutions (hereinafter referred to as trial institutions) and the implementation of Good Clinical Practice for medical device clinical trials conducted for the purpose of registering medical devices (including in vitro diagnostic reagents).

Recently, the Medical Device Technical Review Center of the National Medical Products Administration released the public notice of the review results for priority approval applications for medical devices (No. 7 of 2024). The Hepatitis C Virus (HCV) Nucleic Acid Detection Kit (PCR-Fluorescence Method), submitted by Suzhou Tianlong Biotechnology Co., Ltd., meets the conditions for priority approval and is proposed to be given priority approval. This product falls under the category of "medical devices included in the National Key Research and Development Program." It is used for the quantitative detection of Hepatitis C Virus RNA in clinical serum or plasma samples.