Medical device includes device related to human health, therefore, the business
of medical device in the conditional business line in accordance with the law
of Vietnam. Medical device is defined as kinds of device, tools, materials for
implanting activities, reagents and in vitro calibration solutions, software
which are used separately or in association with each other according to the
instruction of their owners for human use for the purpose of diagnostic,
prevention, supervision, treatment and elimination the illness or to making up
for pains.
For medical device trading purpose in Vietnam, first of all, the
enterprise should classify medical device. Medical device circulated in Vietnam
will be classified based on the level of potential risks associated with the
technical design and manufacture of such medical device.
Pursuant to Decree No.36/2016/ND-CP on medical device management,
medical device shall be classified into the following 2 groups which are
divided into 4 types as follows:
– Type 1 comprises Type A medical
device which is medical device with low level of risks.
– Type 2 comprises Type B, C and D medical
device, where
+ Type B medical device is medical device with lower average
level of risks;
+ Type C medical device is medical device with upper average
level of risks;
+ Type D medical device
is medical device with high level of risks.
In case medical device can be classified into two or more levels
of risk, the classification by the highest risk level of such medical device
shall be applied. The classification of medical device must be conducted by
qualified organizations as provided by law. In addition, the law of Vietnam
recognizes the results of classification of medical device made by competent
regulatory body in other countries such as Korea, Japan, … on the basis of
international treaties or international arrangements to which Vietnam is a
party or of a country which adopts a medical device classification system
similar to that adopted by Vietnam.
After classifying medical device, the enterprise shall declare
applicable standards for Type A medical device or issue certificate of
free-sale registration for Type B, C, D medical device. This procedure makes
sure that medical device which the enterprise has trading requirements, is
allowed to be distributed in Vietnam.
Finally, with the exception of medical device of type A, in order
to directly sell medical device to consumers, the enterprise needs to ensure
the staffing requirements as well as the material facility requirements in
accordance with the law, for instance:
Trading premise must have technically qualified staffs to perform
the installation and use instructions suitable to the medical device which the
establishment buys and sells, including at least one qualified technical staff
specialized in technical or medical or pharmaceutical medical or technical
colleges of medical device or higher or college or higher degree, whose
specialized training is appropriate to the type of medical device that the
establishment purchase.
Trading premise needs to prepare the warehouse which has area in
accordance with the type and the quantity of the medical device to be stored.
The warehouse should be airy, dry, clean, separated from sources of pollution
and satisfied with other storing requirement device according to its manual. In
addition, trading premise shall have suitable transportation vehicles for
delivering of medical devices from trading premise to received place. In case
there are no storage facilities or transport means, a contract with an establishment
satisfying requirements for storage facilities and transport of medical device
shall be concluded
