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
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
Taiwan’s long-anticipated new law regulating medical devices modifies the way devices are classified, mandating they be grouped by product category and risk, adjusts device registration fees, and mandates adherence to certain technical guidelines for preparing documents related to device registration applications. The... Read More
Low insurance reimbursement rates in Taiwan are discouraging the development of innovative pharmaceutical products, according to a study by Fitch Solutions. Because essential healthcare for all residents of the island nation is covered by a single public system, and hospitals negotiate with... Read More
Medical device manufacturers will be required to include unique identification (UDI) codes on the labels of their products sold in Taiwan beginning May 1, under new medical device regulations established by the government. The requirements, released in draft form in January and... Read More
The combination of a relatively low–cost workforce and increasingly reliable quality and ethical standards is turning the Asia-Pacific region into a hub for clinical trials. With pharmaceutical firms under growing pressure to provide innovative new products at reasonable prices, the region is becoming more... Read More
A host of rehabilitative technology companies are entering the Asian market in force, driven by the needs of the region’s aging population for exercise and rehab equipment to combat immobility, muscular atrophy, and the epidemics of heart disease, hypertension, stroke, osteoarthritis, and... Read More
China, Korea, Taiwan, and Japan are rapidly becoming world leaders in cell and gene therapy research and innovation, fueled by significant public and private investment and streamlined regulations that are spurring breakthroughs in the field. All three countries have long been leaders... Read More
Five years after Taiwan first urged medical device manufacturers to include unique identification (UDI) codes on the labels of their products, regulators are seeking public consultation on making the voluntary labeling protocols mandatory. The draft requirements would mandate UDI labels include a... Read More
Sales of diagnostic mammography equipment in the Asia-Pacific region is expected to rise significantly over the next eight years, according to two recently published studies. The reports by Globalcan and GlobalData vary in their specific findings. But both project compound annual growth... Read More