Medical Device Registration in Vietnam 2018-08-21T10:31:12+08:00

Market Opportunity in Vietnam

It is estimated that Vietnam spends nearly 7% of its GDP on healthcare, which is almost double the expenditure of other countries such as India.

Vietnam has experienced a drastic transition to become an emerging market and spending on healthcare and healthcare infrastructure has increased significantly in recent years. It is estimated that Vietnam spends nearly 7% of its GDP on healthcare, which is almost double the spending of other countries such as India.

In addition, the population is also increasing. The growth rate of the population is approximately 1% per year which is equivalent to almost a million births per year. Almost 90% of the medical devices in Vietnam are imported. These include consumables, diagnostic imaging equipment, dental products and orthopedic and prosthetic devices. Devices are imported from various countries including China, the US and Japan.
Domestic production of medical devices remains limited, restricted to low-end devices and basic items such as syringes. About 70% of the medical device purchasers are government-funded hospitals. The medical device market has been growing steadily, reaching an estimated market size of US$200 million in 2013. The market is expected to increase from approximately US$750 million in 2014 to more than US$1000 million in 2019.

The market is expected to expand at a CAGR of 7.9% in 2014 to 2019. The combination of rapid economic growth and an improved healthcare system, together with its growing population, makes Vietnam and attractive market for medical device manufacturers.

Andaman Medical can act as your in-country representative

Foreign manufacturers who do not have a business entity in Vietnam must appoint an in-country representative to act on their behalf in the country. The local authorized representative conducts the product registration process and can support the company with post-marketing activities such as adverse event reporting and customer complaint management.

Medical Device Registration

From 01 July, 2016, the new decree 36/2016/NĐ-CP on Medical Device Management came into effect and have impacted, not only on product registration, but also on trading, importation, manufacturing and market circulation in Vietnam.

An important change in the new medical device regulations is that medical devices are now classified based on a risk classification (group A, B, C, D), rather than function classes (equipment for operation, sterile devices, equipment for anesthesia, etc) as before. Class A medical devices will be managed by the local health department and the product license remains permanently valid. Class B, C and D medical devices will be managed by the Department of Medical Equipment and Construction, Ministry of Health (MOH) of Vietnam. Product licenses will be valid for 5 years from the date of issue. The MOH of Vietnam also issued a guideline for medical device classification and recognition of classification results from the US-FDA, EU, TGA (Australia), Canada, Japan, Korea and the ASEAN region.

The Ministry of Health has delayed the full implementation of Decree No. 36/2016 /ND-CP for medical device class B,C,D to 1 Jan 2020. With the extension, medical devices can still be distributed as per Circular No 30/2015/TT-BYT where import license as per Circular No 30/2015/TT-BYT will still be valid.
For Medical Devices Class A: the implementation shall follow Decree 36.
For Medical Devices Class B, C, D which including the list of medical devices required import license, according to Circular no. 30/2015/TT-BYT on 12 Oct 2015, continue to be imported as per Circular 30.

Services

For foreign manufacturers who are not established in Vietnam, Andaman Medical is able to represent you in the country. Andaman Medical can act as your local representative to handle product registration in the country. As your local representative, we can also assist you in post-market activities including adverse event reporting and customer complaint handling.

Andaman Medical will assist you in compiling the dossier to the Vietnam authority in order to import license for your device
Andaman Medical offers general consulting services such as the provision of regulatory intelligence reports and registration & labelling requirements in Vietnam.