Trading Conditions on Medical Device in Viet Nam

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

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Medical Heathcare Industry

The demand for medical equipment in Vietnam has been increasing due to the need to for treatment for cancer, heart disease, injuries, with focus on imaging equipment, operation room, emergencies resuscitation, intensive testing. The reason behind is the rising income and awareness of treatment for better quality of life. The foreign companies also tend to seek market entry solutions from independent consultant or local partners whom will be distributing the products into Vietnam to maximize the success chance.

In 2012, the size of medical equipment and supplies had been estimated by Ministry of Health at USD 515 m and the growth rate is between 10-11% per year.

However, the market development has been faster than anticipated. In 2016, total investment in medical equipment in Vietnam was USD 950 million USD. By 2017, this figure increased to USD 1.1 bil and that growth rate has been 18% over the past 5 years.

It has been reported 90% of equipment and supplies are imported from Japan, Germany, USA, China and Singapore, the 3 leading countries are United States, Germany and Japan. The imported imaging equipment such as magnetic resonators, CT machines, ultrasound machines, x-ray machines accounted for 30% of the import volume.

The Ministry of Health has policy to improve the capacity of medical equipment production in Vietnam over the last 20 years ago but the success is limited. Currently, there are about 50 domestic enterprises, but mainly produce medical bed and cabinet. The more advanced machines are being assembled by enterprise that cooperate with Japanese and Korean partners.

It has been evaluated that medical equipment is one of four attractive sectors for foreign investors when targeting Vietnam, in addition to investment in electronics, IT and communication and textiles. Public hospitals, which account for 70% of the market share, are still the largest customers of these manufacturers. The remaining other customer groups include foreign invested hospitals, private hospitals and research institutes, universities.

Government investment capital will continue to play an important role and public hospitals will tend to be more self-reliant in seeking financing for medical equipment investments.

For foreign companies entering Vietnam for supplying medical equipment, they have to follow strict process for bidding for public service. It is important for the foreign medical equipment to follow the Vietnam law and undertake regulatory investigation and research on medical equipment there are different implications for the import, sales and distribution into Vietnam.

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