Medical Device Registration in Vietnam

Vietnam's medical device market is about $210 million. According to the International Monetary Fund, from 2000 to 2008, Vietnam's economy grew at an average annual rate of about 7.5% — one of the highest rates in Asia. The medical device market is one of the many beneficiaries of this growth. About 70% of medical device purchases made in Vietnam — measured in terms of value — go to public hospitals.

An important fact about medical device registration in Vietnam is that the basic process is different for imported devices than for domestically manufactured devices. Technically, imported medical devices do not need product registration at all, just an import license. Domestic devices, on the other hand, do generally require product registration.

The Association of Southeast Asian Nations (ASEAN), which includes Vietnam, is currently devising standardized medical device dossier requirements under the Common Submission Dossier Template (CSDT). The CSDT is scheduled to be valid in ASEAN starting in 2010.

For more information on medical device registration in Vietnam, please see the following PBM publications and/or contact us to discuss your specific needs.

Looking East for R&D and Clinical Trials
ASEAN Medical Device Harmonization Trends (webcast for sale)
Vietnam's Medical Markets (webcast for sale)
Vietnam Medical Device and Pharmaceutical Regulations and Overview