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
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
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
In a boon for international medical device manufacturers marketing their products in Vietnam, the country has lowered the value-added tax (VAT) on a range of imported medical device equipment from 10% to 5%. The new tax rate, which went into force in... 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
In a long-anticipated move toward tightening and streamlining approval requirements for medical devices, Vietnam’s Ministry of Health announced in May that approval of Class B, C, and D medical devices will soon be required to use the ASEAN Common Submission Dossier Template... Read More
Continuing to refine its nascent laws regulating the sale of medical devices and IVDs, Vietnam’s Ministry of Health in March drafted new legal parameters that tighten controls on classifying, testing, and conducting clinical trials of medical devices. As drafted, the new regulations... 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
With Vietnam on the cusp of implementing significant new regulations on medical devices, an advisory group made up of former health officials has been formed to ensure the transition goes off without any hitches. The Advisory Council established in November by the... Read More