A recent report by Bain & Company and APACMed (a MedTech trade association located in Singapore) has issued a report on Asian MedTech companies’ growing appetite for ESG initiatives. According to this report, the Asia region has doubled its ESG policies compared... Read More
Please click here to access the presentation: Vietnam Medical Device Reimbursement Read More
Several months ago, Vietnam’s MOH released Circular 10/2023/TT-BY updating pre-market requirements. There is now a new document list for device dossiers. While Class D and Class D devices still need CER reports for submission, Class B devices no longer have this requirement.... Read More
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