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 is not only faster and less expensive than alternative manufacturing methods but also numerous types of material can... Read More
Prices of drugs sold in China will drop by 61.7% on average this year, as the latest update to China’s National Reimbursement Drug List (NRDL) goes into effect. But while the price cut—the most significant slash since 2017 — is a blow... Read More
A raft of changes endorsed in December by Japan’s key policy-making body on drug and medical device pricing would reform the costs of healthcare products in ways designed to reward innovation and stabilize pricing and supply. But the reforms, set to go... Read More
Seeking to boost the domestic market for artificial intelligence software used to diagnose diseases, Japan is moving forward with plans to ease regulations on the technologies by shortening the product approval process and eliminating other requirements. The proposed changes, which could go... Read More
A push by Japan to establish an emergency pharmaceutical approval system modeled on that of the United States is moving forward, with legislation to speed the distribution of drugs and vaccines needed to prevent outbreaks of infectious diseases and other public health... Read More
Two months after Vietnam issued a new decree simplifying the registration of medical devices, the country’s Ministry of Health has announced that thousands of pending device applications will have to be resubmitted to ensure they comply with the new requirements. The move... Read More
As interest has grown in Korea in the rapidly developing applications of medical software to diagnose, treat, cure or prevent disease, regulators have increasingly turned their attention to digital healthcare, particularly Software as a Medical Device (SaMD) technologies. With clinical trials of... Read More
Responding to the needs of more than 61% of citizens who identify as Muslim, Malaysia is set to launch an online system to standardize the certification of medical devices that adhere to the requirements of Islamic law. Under the Islamic requirements, known... Read More
Continuing to strengthen its regulations of imports, Vietnam in December issued a new law mandating that manufacturers determine and label the place where goods imported to the country, including medical devices, originate, including where they are assembled, packed, and labeled. Specifically, the... Read More
As the use of digital therapeutic technologies (DTx) grows in Korea, investment in the technologies is on the rise, and government regulators are taking a closer look at how to evaluate and ensure the safety and performance of the products. In December,... Read More