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.