A unique confluence of key factors fuels China’s leadership and momentum ahead of the US in AI health technology. Massive data availability, low-cost labor to prepare this machine-learning information, and the need to offset doctor shortages contribute to growth in this highly... Read More
Japan is the fastest aging country in the world. With about 125 million people now, their population is expected to decline to 90 million in 25 years. In an effort to increase their population, starting this month, Japan will begin to reimburse... Read More
A Chinese government program to buy pharmaceuticals and medical devices in bulk has been expanded to include a larger selection of devices, putting fierce competitive pressure on foreign medical device companies seeking to tap into the vast country’s market. First launched in 2018... Read More
Japan is way behind the US and EU for approving medical devices with AI. In September 2020, Japan introduced the IDATEN system (improvement design with approval for timely evaluation and notice) which was designed to quickly allow partial modifications of approvals for... Read More
Contact us today for a free consultation with an Asia regulatory affairs consultant to discuss your specific needs. This article was originally published on MedTech Intelligence. 3-D printing has revolutionized product customization and digital manufacturing in various industries. In many instances, it... Read More
More and more device purchasing in China is done via government tenders and procurement. China is now signaling it may ease rules that prohibit foreign companies from obtaining lucrative government procurement deals. That could be good news for foreign medical device manufacturers... Read More
With the COVID-19 pandemic making clear the urgent need to speed approvals and enable flexibility in pricing of innovative biopharmaceutical products, regulators in India have drafted a new set of measures to streamline innovative drug research and development. Released in draft form... Read More
Contact us today for a free consultation with a China regulatory affairs consultant to discuss your specific needs. This article was originally published on MedTech Intelligence. China’s medical device market has grown tremendously over the last five years. While estimates vary on... Read More
Contact us today for a free consultation with a Japan regulatory affairs consultant to discuss your specific needs. This article was originally published on MedTech Intelligence. Japan is still the third largest medical device market in the world, after the United States... Read More
Racing to keep up with the challenges of a fast-expanding biotech sector, China’s regulators are beginning to erect guardrails on how startups can develop, test, and register new drugs. Since September, the National Medical Products Administration (NMPA) has issued more than 15... Read More