Replacing decree #98 with decree #07 will implement new device regulations in Vietnam. To help alleviate price fluctuations of devices in Vietnam, Vietnam initiated a policy that device traders or manufacturers need to list device prices on the Vietnam medical device portal... Read More
In early January, the Vietnamese government extended the validity of certain drug licenses. First, drugs and drug substances with market authorizations that expire this calendar year will be automatically extended until December 31, 2024. Second, drugs and drug substances with market authorizations... Read More
Historically, there have been more drug clinical trials in the West than in Asia. However, recently this has changed, and there are more than 8,000 clinical trials in Asia now and less than 8,000 clinical trials in the West. Please note that... Read More
Late last year, Vietnam’s MOH issued a draft letter addressing device registration. First, Class C and D device applications will now be submitted initially to Conformity Assessment Bodies (CABs) starting on September 1, 2023. Certificates from CABs will go into effect on... Read More
Digital healthcare trends are flourishing in Asia due to its aging population, shortage of healthcare personnel, increasing consumer demand, and technological innovation. According to statistics from Graphical Research, the digital health market in Asia Pacific is expected to grow by 33% from 2020... Read More
In February, Vietnam issued new labeling requirements for goods including medical devices via Decree 111. Medical device labels in Vietnam must include both the owner (name and address) and the owner of the registration number (name and address). If the device does... 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
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