Vietnam has a growing population and economy but its healthcare infrastructure needs modernization. Half of Vietnam's existing medical equipment is obsolete and hospitals lack specialized equipment. The medical device market is expected to grow strongly but domestic production is negligible so Vietnam relies on imports, particularly from Europe, Japan, US, Korea and Taiwan. Refurbished medical systems could help improve healthcare access and affordability if imported through controlled, transparent means and meeting quality standards. Streamlining regulations for in vitro diagnostic products could also enhance healthcare by enabling faster access to important tests and aligning processes with international practices. Flexible shelf life requirements are also recommended to allow high quality diagnostic products to reach patients.

1. Vietnam - Medical Device and Diagnostics - 2015
Overview
With a population of more than 90 million and a steady and robust Gross Domestic Products
(GDP) growth, Vietnam has an important and fast growing need for medical equipment and
diagnostic products. However, the country's stock of medical equipment remains small and
poorly utilised. Much of the country's healthcare infrastructure is in dire need of
modernisation. Recognising the importance of public healthcare in the country's socio-
economic development, the Government has increased funding to improve this sector.
According to the Vietnamese Ministry of Health (MOH), half of the existing medical
equipment in Vietnam is obsolete, and needs to be replaced. Many hospitals are short of
specialised medical equipment, presenting problems for both patients and physicians, as non-
profit organisations, and public hospitals in Vietnam are unable to earn the money necessary
to upgrade their facilities and equipment.
In 2013, the Vietnamese medical device market is estimated at USD 645 million, or USD 7
per capita. It is expected that the device market will continue to expand strongly at over 16%
per annum for the years to come. This will take the Vietnamese market to around USD 1.4
billion in 2018. As domestic production is still negligible, the market relies entirely on
imports from abroad, in particular from the European Union (Germany, France, Switzerland,
Italy), as well as from Japan, the USA, the Republic of Korea, and Taiwan. In 2013, an
estimated 92% of the medical device market was supplied by imports, and the sector is
growing rapidly. Japan, the USA, Singapore and China are the leading suppliers, accounting
for 50.4% of imports in 2013, while local production is mostly limited to basic items such as
syringes and hospital beds.
Refurbished Systems
Relevant Ministries: Ministry of Industry and Trade (MOIT), Ministry of Health (MOH)
Issue description
Vietnam is a member of ASEAN and has signed the ASEAN Medical Device Directive
(AMDD). The AMDD follows for a big part the Global Harmonisation Task Force (GHTF)
guidelines and considers also refurbishment. Implementing regulations for the AMDD are
being drafted and circulated for comments. However, Refurbished Systems (RS) are
currently banned for import today by the Vietnamese authorities because they do not qualify
as 100% new medical devices.
Potential gains/concerns for Vietnam
We believe that Vietnam should open the market for RS in a controlled way. This would be
very helpful for the development of Vietnam's healthcare system as RS is an ideal answer to
market segments where healthcare budget is tight. Customers can save up to 20 - 25% in

2. comparison with the original price, while these systems can still be individually tailored to
customers’ specifications. Refurbished systems following internationally recognised
refurbishment quality guidelines can be considered as good as new equipment from a quality
and safety perspective.
The Vietnamese authorities could distinguish these companies from others and verify their
refurbishment quality standards through internationally valid certificates.
By doing so, the import of RS can be strictly controlled in a transparent manner to ensure
access to affordable technology while ensuring patient safety.
Refurbished systems are already widely accepted in developed markets like the USA and
Europe. Recommendations
We would recommend Vietnam to accept a successful product registration system that is
implemented in any other ASEAN being a signatory of the AMDD, or to accept a successful
product registration/approval from one of the GHTF founding members.
This would include refurbished systems already registered and approved in these countries.
Regulatory Framework for In Vitro Diagnostic (IVD) Products
Relevant Ministry: Ministry of Health (MOH)
Issue description
Currently, the import and sales of IVD products is subject to the same registration process
that is applicable to drugs for which getting approval may take at least one year. The Ministry
of Health has assigned the Department of Medical Equipment and Construction (DMEC)
with the responsibility of granting the so-called 'registration numbers’. However, the
applicable law and expert committee remain the same as for drug registration that is not
familiar to DMEC.
Potential gains/concerns for Vietnam
An improvement of the registration process would enable faster availability for Vietnamese
patients of diagnostics tests with internationally proven clinical value and it would therefore
improve the overall healthcare delivery in the country.
Alignment with international registration practices would also enable major efficiency gains
and reduce the extra need for resources within the MOH as well as within in vitro diagnostics
companies active in Vietnam.
Recommendations
• We realise that the law would need to be amended before registration regulation can
be changed. Therefore, for the time being we would recommend DMEC to take into
consideration international practice and to treat IVD products as medical devices by

3. simplifying registration requirements as much as possible to allow MNCs with high quality
products access for Vietnamese people.
• We believe that a good long term solution would be to follow international
registration practices, to implement AMDD into local regulations and to minimise country
specific requirements. Furthermore, we would recommend accepting a successful product
registration/approval from one of the GHTF founding members.
Shelf-Life of IVD Products
Relevant Ministry: Ministry of Health (MOH)
Issue description
Many In Vitro Diagnostic (IVD) products are manufactured from biological materials such as
human blood, antigen, and antibody, and its stability is variable which leads to shelf-life
discrepancies between different lots of finished products. This is a natural characteristic of
biological-originated IVD products, and it is recognised by many health authorities around
the world. However, Vietnamese authorities consistently request a fixed shelf-life of IVD
products while refusing to allow for any variations. Specifically, in practice, the MOH require
registering a fixed shelf-life on application, whereas customs always check the consistency of
shelf-life as mentioned on the product licence with the physical product documents before
clearance.
Moreover, due to the specific nature of human blood-originated products, some IVD products
such as calibrators and controls for immunoassay have a very short shelf-life, ranging from
one month to three or four months only. Meanwhile, current regulations require the
remaining shelf-life of IVD products with a shelf-life of less than 12 months to be at least
three months.
Potentials gains/concerns for Vietnam
The aforementioned generates challenges to deliver high quality products to Vietnamese
people while equivalent products are not yet manufactured at local level.
Recommendations
We would respectfully recommend the Ministry of Health (MOH) to accept variant shelf-life
requested in registration procedures as well as to remove the requirement of minimum
remaining shelf-life of three months for IVD products with shelf-life below 12 months as
recognised by many health authorities worldwide. If the MOH and Vietnam customs would
follow our recommendations, patients would be better serviced with a full range of essential
and high quality products.
Please contact Oliver Massmann under Uomassmann@duanemorris.comU if you have any
questions.