Trading Conditions on Medical Device in Viet Nam

Medical devices include devices related to human health, therefore, the business of medical devices 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 purposes in Vietnam, first of all, the enterprise should classify medical devices. Medical devices circulated in Vietnam will be classified based on the level of potential risks associated with the technical design and manufacture of such medical devices.

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 a 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 devices 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 devices, the enterprise shall declare applicable standards for Type A medical devices or issue certificate of free-sale registration for Type B, C, D medical devices. This procedure makes sure that medical devices 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 devices according to its manual. In addition, trading premises shall have suitable transportation vehicles for delivering 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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The Cases of Transferring Money from Vietnam Abroad

In the context of international economic integration, more and more foreign investors are coming and investing in Vietnam. Besides, many Vietnamese individuals and organizations have also implemented many investment activities, living, traveling… abroad. Therefore, there are needs to transfer money from Vietnam abroad. According to the provisions of Vietnamese laws on foreign exchange management, domestic individuals and organizations are allowed to transfer money abroad in the following cases:

For individuals being Vietnamese citizens, they are entitled to buy, transfer or bring foreign currencies overseas according to the State Bank’s regulations for the following purposes: to study and receive medical treatment abroad; traveling; business trip; visiting abroad; to pay charges and fees to foreign countries; allowances for relatives members living abroad; transfer of inheritance money to overseas heirs; transfer money in case of permanent residence abroad; One-way money transfer for other legitimate needs.

For enterprises, they are allowed to transfer money abroad when performing the following cases: Carrying out payment and transferring money related to the import or export of goods and/or services; payment of payments and remittances related to commercial credits and short-term bank loans; make payments and transfers related to direct and indirect investment income; transfer money when being allowed to reduce direct investment capital; payment of debts and interest of foreign loans; make one-way money transfers; payment and other remittance according to regulations of the State Bank of Vietnam.

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Vietnam Ratifies the Comprehensive and Progressive Agreement for Trans-Pacific Partnership

Vietnam has recently ratified the Comprehensive and Progressive Agreement for Trans-Pacific Partnership – CPTPP (before Trans-Pacific Strategic Economic Partnership Agreement – TPP. This Agreement was signed on 08 March 2018 in Santiago, Chile including 11 countries New Zealand, Canada, Japan, Mexico, Singapore, Brunei, Chile, Malaysia, Peru, Australia and Vietnam.

TPP was initially expected to form the largest free trade area in the world with the participation of the United States of America (USA). Nonetheless, the President of the USA – Mr. Donald Trump – withdrew the US from TPP, and the remaining members have to re-negotiate and establish CPTPP as a result. Eleven countries participating in the CPTP have a total GDP of USD 10,000 billion equivalent to 13.5% of global GDP.

CPTPP will contribute to boost the export of goods to major markets such as Japan, Australia, Canada and Mexico as well as attract foreign investment into the sectors that Vietnam needs to be developed. Further, this participation has established trade relations with the countries which have never signed a free trade agreement with Vietnam before such as Canada, Mexico or Peru. One of the commitments of CPTPP, the members of CPTPP agree to eliminate import duties on almost all products within 7 years, and Vietnam is flexible up to 10 years. Joining CPTPP, Vietnam not only commits to open up markets, remove tariff barriers, continue to open and facilitate trade, but also continues to show the transparency of the State management on market’s development. The business lines being benefited directly and strongly from CPTPP are garment, textile, footwear, food manufacturing, drink, confectionaries, tobacco, …which is expected to receive investment from overseas through setting up factory, company and business joint ventures in Vietnam.

Further, CPTPP regulates the new legal issues being labour, environment, government procurement, Intellectual Property, state enterprises, …The CPTPP essentially retains the provisions of the TPP Agreement, but with the USA withdrawal, it allows Member States to reserve a number of articles to ensure the balance in the new situation.

In conclusion, Vietnamese enterprises should firstly keep up the commitments of CPTPP in order to seek up the favorable policy trends and to prepare the plans to build competitiveness and enhance the prestige of brand and product quality.

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Danang's Target in 2020 is "The Year of Promoting Investment Attraction"

On December 04th, 2019 Da Nang city held the conference on the result of socio-economic development in 2019 and the target of the city in 2020. The conference affirmed the situation of implementing the city’s political duties, ensuring some criteria for socio-economic development of the city. In 2019, the city has achieved some outstanding results such as: budget revenue exceeded the assigned estimate (estimated at VND 28.170 billion, reached 102,9% of the estimate, up 3,5%; attracted more than 3.696 billion dong of domestic investment and more than 658 million USD of foreign investment capital (newly granted investment certificates of 118 FDI projects with a total registered capital of 437,13 million USD, 8 times higher than the same period); Total tourist arrivals were estimated at 8.69 times, up 13.4%, revenue from tourism activities was estimated at 30.973 billion VND, up 16,7%. In the year, social order and safety were maintained, and is considered by many investors and tourists to be a destination for investment and tourism.

In 2020 is particularly important, the last year to implement the 5-year plan from 2016 to 2020 and the year of many political and cultural events. At this 19th Conference, the Conference agreed on the theme of 2020 as “The year of promoting investment attraction” with specific tasks to focus on implementing: promulgate new preferential policies of the city to attract investors; implement plans on improving the quality and efficiency of foreign investment cooperation; continue to improve infrastructure, expand high-tech zones, create land fund to call for investment; continue to remove obstacles in the planning, land management, human resources for businesses and investors. In 2020, the city will actively coordinate with ministries and branches to submit to the National Assembly for approval of the Resolution on Da Nang construction and development to 2030, with a vision to 2045; on that basis, submit to the Government for promulgation a decree on specific mechanisms and policies on city development. 

In addition, with the goal of attracting foreign investors, the city hopes to receive more investors from many countries around the world to invest in high-tech and technology industries, biology, environmental protection projects, tourism development, etc. through setting up a company factory in Da Nang City. This is a great opportunity for international investors to seize the opportunity to invest in Da Nang today, in order to enjoy the incentives, as well as the highest investment efficiency in the future.

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How Foreigners Could Buy Real Estate in Vietnam?

Regulations on foreigners owning real estate in Vietnam are regulated in Civil Code 2015, Law on Land 2013, Law on Housing 2014, Decree no. 99/2015/ND- CP on guidelines the Law on Housing and related documents.

For land, foreign individuals are not eligible to use land assigned or leased by the State, recognized land use rights, and received transfer of land use rights. However, a foreign-invested enterprise could be allocated or leased land by the State, recognized land use rights, or received a land use right transfer. Foreign-invested enterprises that are assigned land by the State with the collection of land use levies to execute investment projects on the construction of houses for sale or for sale in combination with lease.

For housing, foreign entities eligible for the homeownership in Vietnam include: foreign entities who invest in project-based housing construction in Vietnam as prescribed in this Law and corresponding regulations of law; foreign-invested enterprises, branches, representative offices of foreign enterprises, foreign-invested funds and branches of foreign banks operating in Vietnam (hereinafter referred to as foreign organization); foreign individuals who are allowed to enter Vietnam.

The foreign entities are eligible for the homeownership in Vietnam if they invest in project-based housing construction in Vietnam as prescribed in this Law and corresponding regulations of law; or buy, rent and purchase, receive, or inherit commercial housing including apartments and separate houses in the project for housing construction, except for areas under management relating to national defense and security as prescribed in regulations of the Government.

Foreign organizations and individuals must have documents proving being the eligible subjects and meeting conditions to own houses in Vietnam. A foreign individual must have an unexpired passport bearing the entry seal of the Vietnam’s immigration authority and not be given diplomatic immunity and privileges according to Ordinance on diplomatic immunity and privileges of diplomatic missions, consular offices, and representative authorities of international organizations in Vietnam. Foreign organizations must be subjects of owning houses in Vietnam which have investment registration certificates or a permission issued by a Vietnam’s competent authority for operation in Vietnam which is still unexpired at the time of housing transaction (hereinafter referred to as investment registration certificate).

A foreign entity shall not be granted a Certificate of the house and may only sell or offer it to another entity eligible to own housing in Vietnam in the case being: a foreign organization or individual receives a house as an inheritance or a gift which is located in an area in which foreign entities must not own houses, or the quantity of which exceeds the permissible limits; a foreign organization that does not operate in Vietnam, or a foreign individual who is not permitted to enter Vietnam, receives a house in Vietnam as a gift or an inheritance.

For specific situations, to avoid future dispute in house ownership arisen from the purchase, lease of property, house, land from the state, developer or other seller, or lessor it is important that the client check with property lawyers for eligibility, conditions and other relevant matters.

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Which Areas Are Incentivized For Investment in Vietnam Under Decree No. 37/2020

Investors are always interested in areas which the government incentivize for investment in Vietnam, to enjoy benefits i.e. tax reduction, tax exemption, land usage…which give them some help to grow the business in areas which are not economically potential without the help from the government when setting up a company in Vietnam.

According to the regulations on business investment in Vietnam in Decree No.118/2015/ND-CP, investment projects eligible for investment incentives are entitled to tax and land policies in their performance. Accordingly, for businesses that invest in industries or areas enjoying investment incentives, there will be many advantages related to tax and using land when performing business.

According to the provisions of Appendix I, Decree No.118/2015/ND-CP, the fields are preferentially invested in many fields such as science and technology, electronics, mechanics, material production, and information technology, agriculture, environmental protection, infrastructure construction, education, culture, sports, health activities of People’s Credit Funds and microfinance institutions are specified in Appendix I Decree no. 118/2015/ND-CP.

However, with the continuous development of the economy, along with the development projects of many small and medium-sized enterprises, besides start-up projects, it is more suitable to the market economy and start-up situation of many investors, on March 30th 2020, the Government has issued Decree No.37/2020/ND-CP supplementing the list of preferential investment industries which will take effect from May 15th, 2020.

According to the provisions of Decree No. 37/2020/ND-CP, for business investment activities in accordance with the Law on Support for Small and Medium Enterprises with the following business lines which will be added to the list of industries to enjoy incentives for investment in Vietnam, including business investment in the product distribution chain of small and medium-sized enterprises, business investment in incubation facilities for small and medium-sized enterprises, business investment in technical facilities supporting small and medium-sized businesses, investing in a common working area for small and medium-sized start-ups.

The investors who invest in Vietnam in the business lines above in supporting industries for small and medium-sized enterprises from May 15, 2020, will be entitled to specific tax and land incentives specifically as required by law. Domestic and foreign investors could utilize the opportunity to make investment to enjoy the incentives in Vietnam when conducting businesses.

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Withdrawal of request for investigating of anti-dumping on welding material products originating from China, Thailand and Malaysia

Welding material is one of the most important industrial auxiliary sectors, which is indispensable to fields such as: shipbuilding, cars and motorbikes production, and other electronic industries. In the first 7 months 2019, the Ministry of Industry and Trade carried out examination dossiers of 3 cases, one of them is a dossier requesting to investigate to apply anti-dumping measures on welding material.

On Jun 28th, 2019, Trade Remedies Authority of Vietnam (Investigating Body) received the Dossier requesting for investigating to apply anti-dumping measures on welding material products originating from People’s Republic of China, Kingdom of Thailand and Malaysia. This dossier is applied by companies representing the domestic industry (Requesting Party).

Requesting Party includes 01 company: Kim Tin Group Joint Stock Company. Kim Tin Group Joint Stock Company is a large enterprise in manufacturing and trading of welding materials: welding rods, welding wire, welding flux, color metal, steel nails, ligature, machines, devices, board of MDF, mineral exploitation and logistics service in Vietnam.

On Oct 28th, 2019, the Requesting Party fully submitted additional information at request.

On Nov 07th, 2019, the Investigating Body confirmed that Dossier was complete, valid according to regulations of law on trade remedies.

On Jan 25th, 2020, Trade Remedies Authority received official dispatch from the Requesting Party on withdrawing dossier requesting for investigating to apply anti-dumping measures on welding material products.

Due to the Requesting Party’ s request for withdrawing dossier, Trade Remedies Authority informed that no investigation to apply anti-dumping measures on welding material products originating from People’s Republic of China, Kingdom of Thailand and Malaysia is initiated.

Our international trade and tax lawyers, and antitrust lawyers at ANT Lawyers, a law firms in Vietnam have always followed the development of the situation and updated the clients on relevant matters.

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US Anti-Dumping and Countervailing Duty Petitions of Tire Products From Vietnam

On May 13, 2020, The United States Department of Commerce (“DOC'') has received an investigation request for anti-dumping and countervailing measures against passenger and light truck tires (“PVLT tires”) originating from Korea, Taiwan-China, Thailand and Vietnam. The mandatory respondents being US importers have also consulted with anti-dumping and countervailing duty lawyers in Vietnam and US to prepare for the investigation cooperation.

In this case, the plaintiff alleges that the tires under investigation were dumped and subsidized into the United States market, causing significant damage to the domestic manufacturing industry. In 2015, the same petitioner succeeded in securing anti-dumping and countervailing duties on PVLT tires from China.

The scope of these investigations is passenger vehicle and light truck tires. Passenger vehicle and light truck tires are new pneumatic tires, of rubber, with a passenger vehicle or light truck size designation. Tires covered by these orders may be tube-type, tubeless, radial, or nonradial, and they may be intended for sale to original equipment manufacturers or the replacement market. The products covered by the investigations are currently classified under the following Harmonized Tariff Schedule of the United States (“HTSUS”) subheadings: 4011.10.10.10, 4011.10.10.20, 4011.10.10.30, 4011.10.10.40, 4011.10.10.50, 4011.10.10.60, 4011.10.10.70, 4011.10.50.00, 4011.20.10.05, and 4011.20.50.10. The scope could also include tires entering under HTSUS subheadings 4011.90.10.10, 4011.90.10.50, 4011.90.20.10, 4011.90.20.50, 4011.90.80.10, 4011.90.80.50, 8708.70.45.30, 8708.70.45.46, 8708.70.45.48, 8708.70.45.80, 8708.70.60.30, 8708.70.60.45, and 8708.70.60.60.

Petitioner alleges the following dumping margins: 45.95% to 195.20% for South Korea, 21% to 102% for Taiwan, 106.4% to 217.5% for Thailand, and 14.73% to 33.06% for Vietnam. The petitions also detail numerous government subsidies benefiting Vietnamese tire producers, including loans, tax breaks, and grants. PVLT tire imports from these four countries shot up nearly 20% from 2017 to 2019, reaching 85.3 million tires, valued at 4.4 billion dollars, last year.

According to data from the United States International Trade Commission (“USITC”), the export value of Vietnam’s investigated products to the United States market reached 12.1 million dollars in 2019, accounting for about 6.7% of total United States imports of this product.

In Vietnam, the product under investigation is a product that has been warned by the Ministry of Industry and Trade of risks of foreign investigation by applying trade remedies measures from July 2019 with a high level of warning. Therefore, in the past time, the Ministry of Industry and Trade has actively coordinated and worked with associations and exporters to the United States to actively capture information and respond in case of initiating an investigation. Under United States regulations, the DOC will consider initiating an investigation of the case within 20 days of receiving it. In the event that the DOC decides to initiate an investigation, the Ministry of Industry and Trade of Vietnam will closely coordinate with export associations and enterprises in investigating the case and have timely support and treatment measures to protect the legitimate rights and interests of Vietnamese enterprises.

Vietnam international trade lawyers in competition, and anti-dumping practice will need to be involved with the process including data collection and possibly initial drafting of questionnaire responses in cooperation with US anti-dumping and countervailing duty lawyers to defend the case.

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Questionnaire on Quantity and Value to Foreign Manufacturers and Exporters

On July 14th, 2020, the Trade Remedies Authority of Vietnam (TRAV), Ministry of Industry and Trade issued an investigation questionnaire on quantity and value to foreign producers and exporters in the AD11 case.

Accordingly, TRAV recommends that the related parties who participate in responding to the questionnaire, carefully study the guidelines in the questionnaire before responding and submitting.

In order to ensure the best rights and interests, TRAV recommends that all related producers/exporters participate in full cooperation during the investigation process. The content of the response is one of the important grounds for TRAV to consider and select samples that limits the scope of the investigation. TRAV is entitled to consult with experts or to inspect, verify the authenticity of information and documents provided by related parties or collect additional information and necessary documents to resolve trade remedies cases, including foreign onsite investigations.

In the event that TRAV does not receive the timely response or the information provided is inadequate or insufficient as required, TRAV will apply the relevant law provisions regarding the non-cooperation of the related party in trade remedies cases.

The response to the questionnaire must be sent in full, including 01 confidential copy and 01 public copy (hardcopy of the response) and 01 USB containing the full soft copy of the response and attached annexes. The response is considered to be submitted on time when the TRAV receives all hard and soft copies before 5p.m on July 31st, 2020 (Hanoi time).

AD11 refers to the the anti-dumping investigation case under Decision No. 1715/QD-BCT regarding the Investigation of imposing Anti-dumping measure to some High Fructose Corn Sweetener Products with the HS Code of 1702.60.10 and 1702.60.20 from People’s Republic of China and Republic of Korea (Case AD11). Related parties may by themselves or authorize experienced law firms in Vietnam on international trade to work with Trade Remedies Authority of Vietnam to cooperate.

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