Despite generally reduced medical insurance in Japan for medical devices, the Japanese government may increase coverage of some medical device software products in 2022. The Japanese medical device industry has proposed to the reimbursement arm of the PMDA – Central Social Insurance Medical... Read More
The latest round of negotiations between the Chinese government and pharmaceutical firms has yielded massive price cuts for consumers in the country on more than 65 new brand-name drugs in return for access to the second-largest pharmaceutical market in the world. The... Read More
Driven by the urgent need to speedily combat the COVID-19 epidemic, Japan plans to ease its famously stringent requirements on clinical trials of vaccines and other essential drugs, laying the groundwork for rapid approval when emergency need is deemed to be overwhelming.... 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
China’s National Medical Products Administration (NMPA) in November announced the creation of a platform to collect information related to all active pharmaceutical ingredients (APIs) in circulation in the country. The new platform will allow NMPA, which drafts laws and regulations for drugs,... Read More
Moving to streamline requirements for the approval, licensing, and management of medical devices, Vietnam is now requiring all classes of the devices to be registered with government regulatory authorities. But under a new law that goes into effect January 1, device registration... Read More
With the popularity of health care apps linked to wearable devices exploding in Korea, a government-affiliated medical research institute in the country is recommending authorities establish guidelines to ensure the apps are accurate, reliable, and effective. The Korea Health Industry Development Institute... Read More
Manufacturers seeking licenses to sell high-risk medical devices in Thailand will have a route to do so more rapidly and at less cost under a new agreement struck between regulatory authorities in the country and their counterparts in Singapore. Under the agreement,... Read More
Japan medical device reimbursements will generally go down slightly in 2022, but some new technologies with clear benefits will not. Discussions on reimbursement revisions in 2022 are being held by the Insurance Medical Material Special Subcommittee of the Central Social Insurance Medical... Read More
Moving with increasing urgency to encourage the development of drugs to treat rare diseases, Chinese regulators are planning for the first time to authorize real-world studies of orphan drugs. Technical guidelines released in October by the National Medical Products Administration’s Center for... Read More