Seeking to stem confusion among drug and medical device manufacturers, China’s regulatory authorities in July released a draft set of rules clarifying how to register products combining both medical devices and pharmaceuticals in the country. The draft Guidelines for the Registration Review... Read More
Signs are emerging that China will tighten its policies governing clinical trials of drugs produced in the country, part of a series of moves to bolster the study of the safety and effectiveness of pharmaceuticals and to bring them fully in line... Read More
Chinese biotechnology firms have lagged behind their competitors for years in the use of artificial intelligence technologies. But increasingly, regulatory reforms are making it easier and cheaper for pharmaceutical companies in China to harness a vast trove of data collected from Chinese... Read More
On July 8, 2021, the China National Medical Products Administration (NMPA) issued Announcement No. 47 to provide guidelines for the classification and regulatory submission of Artificial Intelligence (AI) medical devices. The announcement distinguishes whether an AI product is a medical device or... Read More
Continuing to strengthen China’s oversight of the manufacture, import, and distribution of pharmaceuticals, the country’s health regulators in May published a series of measures medical institutions will be required to follow in prescribing and utilizing drugs to treat cancer. The measures released... Read More
With an estimated medical device market size of over 50 billion USD and growth rate of 10% per year, China has become an attractive market, full of opportunities, for foreign medical device companies. Foreign manufacturers of medical device components and raw materials... Read More
Spotify: https://open.spotify.com/episode/61krNTBfW9nKHadjtOOIuT?si=zGlmcBWnTUKGYT7qXOo1XQ&dl_branch=1 Apple: https://podcasts.apple.com/us/podcast/project-medtech/id1513851432?i=1000527075358 Read More
Moving to rapidly put in place its new Unique Medical Device Identification (UDI) system to track medical devices, Chinese regulators have announced the second group of devices that will be required to employ the system. All Class 3 medical devices will be... Read More
Attracted by Shanghai government policies designed to encourage the development of the pharmaceutical industry, Western drug manufacturers are setting up shop in China’s financial hub. The biopharmaceutical firms are partnering with Chinese industry leaders, taking advantage of a reservoir of talented biopharma... Read More
In an across-the-board effort announced by the Chinese government in May, the country’s health regulators are making plans to strengthen oversight of the manufacture, import and distribution of pharmaceuticals. The announcement from the General Office of the State Council outlined a range... Read More