China’s NMPA has given 10 of Sihuan Pharmaceutical Holdings Group Ltd.’s skin repair products medical device registration certificates. The products are developed by its medical aesthetics platform, Beijing Meiyan Kongjian Biology Medicine Co. Ltd.
Saluda Medical Pty Ltd. raised $125 million in equity financing to commercialize and scale up its Evoke spinal cord simulation system for chronic pain and to advance its technology platform across an emerging portfolio of neuromodulation therapies.
Even as China sees strong and continuous growth in patent applications from its medical technology industry, regulators are imposing stricter regulations to curb what they see as "abnormal applications." China’s medical technology sector saw year-on-year growth of 28.7% in 2021 for valid invention patents, according to data from the China National Intellectual Property Administration.
Japan’s Ministry of Health, Labor and Welfare (MHLW) released a number of new guidelines and clarifications on medical device regulatory issues including cybersecurity, remanufactured single-use devices (SUDs) and the Medical Device Single Audit Program (MDSAP).
India’s health care industry stakeholders have been left scratching their head as authorities, who have championed self-reliance and increased supplies, provided mixed signals in recent notices.
The Chinese government has launched a series of regulations regarding intellectual property (IP) to improve the quality of patent applications. “These new IP rules reflect the Chinese government's continuous effort in fighting the long-existing and more severe ‘abnormal patent filing activities’ and ensuring the quality of patent applications with practical restriction measures,” Binxin Li, an IP partner in Fenxun Partners, Baker McKenzie's joint operation platform partner in China, told BioWorld.
Japanese researchers have created complex 3D kidney organoids that could lead the way to better kidney research and even artificial kidneys for human transplant.
South Korea’s Gwangju Institute of Science and Technology (GIST) has completed a preclinical study for a noninvasive therapy for Alzheimer’s disease. The "ultrasound-based gamma entrainment” technique involves syncing up gamma waves, or brain waves above 30 Hz, with an external oscillation of a given frequency. This happens naturally by exposing a subject to a repetitive stimulus, such as sound, light, or mechanical vibrations.
Beijing Microkpro Medical Instrument Co. Ltd. has received marketing approval for its artificial cornea from China’s NMPA. Miok Keratoprosthesis is the world’s first artificial cornea made of 100% non-biological materials and does not require co-implantation of donor corneas, according to Microkpro Medical.
Targetingone Corp. Ltd.’s new testing kit based on digital polymerase chain reaction (dPCR) techniques has received approval from China’s NMPA. It is the first dCPR-based testing kit to receive the country’s class III medical device registration certificate. The Beijing-based company collaborated with Tsinghua University, several hospitals and the Chinese Center for Disease Control and Prevention (CDC) participated to research and develop the testing kit.
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