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. The certification is for three scar repair products, four medical dressing and patch products, as well as three skin repair products.
China’s NMPA has approved 12 antigen self-test kits between March 12 and 16 amid COVID-19 outbreaks in many parts of the country. The regulator claims that there will soon be more test kits approved. The number of COVID-19 infectious cases in China surged rapidly over the first half of March.
Neuton Health Co. Ltd.’s virtual reality (VR)-based therapy for acrophobia has been given class II medical device approval from China’s NMPA. The VR therapy, known as Specific Fear Rehabilitation Training Software, was co-developed with the Shanghai Mental Health Center. The digital therapy company said it is the first VR device of its kind for a specific phobia approved in the world.
Singular Health Group Ltd. entered a 50-50 joint venture in Macau that will explore the potential of Singular’s Scan to Surgery software for the East Asian market, which the company has long seen as a key opportunity for its 3D software and medical 3D printing ambitions.
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.
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.
Chinese company Seekin Inc. is preparing to launch its cancer detection technology in Europe after securing CE marking for the Seekincare pan-cancer test. The artificial intelligence, blood-based platform uses insights from public and private data to identify cancer DNA and protein signals in the blood. The test has been available in Chinese labs since 2018.
The EU initiated a dispute complaint with the World Trade Organization over China’s intellectual property (IP) enforcement allowing Chinese courts to block infringement litigation worldwide. The Feb. 18 complaint, posted by the WTO last week, takes issue with Chinese courts issuing global injunctions barring patent holders from asserting their rights through legal proceedings in other countries until the case is settled in China.
Tariffs applied to goods imported for China were imposed by the Trump administration as part of a larger effort to reset the U.S. trade deficit, but there were several exclusions for medical devices in the interest of maintaining access.
Over the past few years, China has been quick to make promises to improve its regulatory and patent schemes for biopharmaceuticals and medical devices in keeping with its World Trade Organization (WTO) commitments, but it’s been slow to fulfill those promises – at least in the eyes of the Office of the U.S. Trade Representative (USTR).
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