Medical Device News Brief (Dec 31): Hengqin-Macao Cooperation Zone Eases Market Access; Non-Invasive Glucose Monitoring Registration Guidance Released

1. Two Departments: Supporting the Hengqin Guangdong-Macao In-Depth Cooperation Zone in Relaxing Special Measures for Market Access

Recently, the National Development and Reform Commission and the Ministry of Commerce issued the "Opinions on Supporting Hengqin Guangdong-Macao In-Depth Cooperation Zone in Relaxing Market Access with Special Measures," which proposed to innovate market access methods in the pharmaceuticals and healthcare field. It encourages the conduct of real-world data application research in clinical settings and explores the use of real-world clinical data for the registration of drugs and medical device products. It supports the cooperation zone's market regulatory departments in managing export sales certificates for Class II and III medical device products. Enterprises in the cooperation zone producing Class III medical devices approved for clinical use in China will charge according to the price policies for medical devices and medical services. It studies the feasibility of convenient delivery through a specific dedicated channel between Hengqin and Macao for reasonable self-use over-the-counter medicines purchased by Macao residents in the cooperation zone. At the same time, it allows foreign high-level medical aesthetics doctors to independently perform medical aesthetics procedures after registering as chief consulting physicians in medical aesthetics in accordance with relevant regulations. (Ministry of Commerce)

2. "Guiding Principles for Registration Review of Non-Invasive Blood Glucose Monitoring Products" Released

Recently, the Evaluation Center released the "Guiding Principles for Registration Review of Non-invasive Blood Glucose Monitoring Products" to standardize the management of such products. Non-invasive blood glucose monitoring products estimate glucose concentration by detecting local tissue metabolism and provide blood glucose values non-invasively. The Guiding Principles state that applicants should clearly define the target patient population and intended monitoring information for specific groups, or provide a statement if no specific group is intended, such as newborns, pediatric patients (including infants), adults, pregnant women, etc. If the use of non-invasive blood glucose monitoring products is not recommended, the applicant must specify this clearly. Applicants are required to provide clinical evaluation data for non-invasive blood glucose monitoring products. Unless the product falls under the category in Part III of the "Guiding Principles on Deciding Whether to Conduct Clinical Trials for Medical Devices," which may exempt it from clinical trials, in principle, applicants should conduct clinical evaluations through clinical trial pathways. (Evaluation Center)

3. Guiding Principles for the Registration Review of Spectral Imaging Technology in X-ray Computed Tomography Equipment (Draft for Comments)

Recently, the Center for Medical Device Evaluation of the National Medical Products Administration has publicly solicited opinions on the "Guiding Principles for the Registration and Review of Spectral Imaging Technology in X-ray Computed Tomography Equipment (Draft for Comments)." The deadline for feedback is January 26, 2024. This guiding principle serves as a supplement to the "Guiding Principles for the Technical Review of Registration for X-ray Computed Tomography Equipment" and specifies dedicated requirements for spectral imaging technology. CT products with spectral imaging functionality must ensure their registration documentation complies not only with the requirements of the CT guiding principles but also with those outlined in this guiding principle. (Evaluation Center)

4. Two Innovative Medical Devices from Jinjiang Electronic Approved

Recently, the National Medical Products Administration approved the innovative product registration applications of "Disposable Cardiac Pulsed Field Ablation Catheter" and "Cardiac Pulsed Field Ablation Instrument" from Sichuan Jinjiang Electronic Science and Technology Co., Ltd. The disposable cardiac pulsed field ablation catheter consists of a catheter and a connecting cable, while the cardiac pulsed field ablation instrument comprises a main unit, an output box, and accessories. This marks the first cardiac pulsed field ablation product in China. These two products are used together to control and release appropriate levels of pulsed field energy, selectively causing irreversible electroporation damage to myocardial cells at the targeted lesion sites, thereby treating atrial fibrillation. This provides more options for treating drug-refractory, recurrent, symptomatic, and paroxysmal atrial fibrillation. (36Kr)

5. Professional analysis report on medical devices provided for research, investment, decision-making, and listing

It is reported that after 20 years of experience in the medical device field, Osmunda, based on its professional medical device database - MDcheck, and relying on artificial intelligence and big data technology, has launched a heavyweight product — Medical Device Product Report Software. This software provides investors, entrepreneurs, medical device professionals, and research experts with professional medical device product analysis reports during the processes of research, investment, decision-making, and going public. It features comprehensive analysis, full-category coverage, customized matching, and one-click generation, eliminating any "difficult situations" in the industry. (Compiled by Osmunda)

6. Disiyi Medical Secures Tens of Millions in Pre-A++ Round Financing

Recently, Hangzhou Disi Medical Biotechnology Co., Ltd. announced the successful completion of a Pre-A++ round of financing worth tens of millions of yuan. This marks the company's third round of financing within a year. The round was led by Fortune Venture Capital, with WinX Capital continuing to serve as the exclusive financial advisor. The funds will primarily be used to advance the NMPA registration of ophthalmic surgical robots and to promote the research and development of product lines such as microsurgical robots. Disi Medical, established in July 2021, is a national technology-based small and medium-sized enterprise specializing in ultra-micro surgery. To date, Disi Medical has applied for and been granted several U.S. and Chinese invention patents, received multiple awards in competitions both globally and domestically, and launched several research projects in the field of surgical robotics in collaboration with renowned medical institutions in China. (Yiou)

7. Yuewei Medical Receives Nearly 100 Million Yuan in A+ Round Investment

Recently, Yuewei Medical announced the completion of a nearly 100-million-yuan A+ round of financing. This round was led by Nuoyu Capital, with investments from Zhongnan Venture Capital Fund and Qichen Holdings, while existing shareholders IDG Capital and Yuanhui Chuangyi continued to increase their investment. This financing marks the second round quickly completed within a year by Yuewei Medical, following the A round in April 2023. Beijing Yuewei Medical Technology Co., Ltd., established in 2021, is an innovative enterprise focused on the research and development of devices for cardiac surgery and heart failure. Based on the founding team's years of clinical experience in cardiac surgery, the company identifies clinical needs and develops multiple medical devices that fill clinical gaps, accelerating the trend of local production of high-end medical devices in China’s cardiac surgery field. (36Kr)

8. Zhihu Releases Annual "Nine Major Tech Events"

Recently, the "Dawn·2023 Science and Technology Review" event organized by Zhihu Technology and Science has attracted significant attention. With breakthroughs in frontier technologies as its focus, the event released the annual "Nine Major Science and Technology Events" list, showcasing the "dawn moments" of science and technology in 2023 at the application level closely related to people’s lives. The nine major science and technology events are: the debut of ChatGPT, the initial success of mRNA vaccines in the COVID-19 pandemic, the fierce competition in solid-state battery technology, the approval of the world's first CRISPR gene-editing therapy, RISC-V reshaping the chip landscape, China's new-generation "artificial sun" setting a new operational record, a new Alzheimer's drug receiving full FDA approval, SpaceX Starship's two test flights, and lab-grown meat being approved for sale in restaurants. (ScienceNet)