It is estimatedthat around 90% of medical devices in Vietnam are imported while local manufacturers only supply 10% of market demand. Moreover, investment in health care from both the public and private sectors is increasing rapidly. With 18% growth rate in the past 5 years, the outlook of the medical device industry is expected to be positive in the future. This is guaranteed by 3 key growth drivers: increasing life expectancy, modernizing public health care facilities and encouraging international initiatives to ease regulations on imported devices.
Under current regulations, medical devices in Vietnam are categorized into 4 types: class A, B, C, D. All medical devices imported into Vietnam are required for registration by submitting a registration dossier to the regulatory authority. There are 2 regulatory authorities in Vietnamresponsible for medical devices: the Provincial Department of Health for class A and Department of Medical Equipment and Construction (DMEC) for class B, C, D.
1. Vietnam medical device classification
Medical devices in Vietnam are classified and regulated through their potential risk to patients, health staff and the community. There are 4 types: Class A (low risk), class B (low-medium risk), class C (medium-high risk) and class D (high risk).Classification certificate of medical devices are issued by qualified local entities in Vietnam.
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