HOW TO IMPORT AND TRADE MEDICAL DEVICE

Import of medical device is a complicated process under Vietnam laws as it applies and impacts on human bodies. Ministry of Health is the Vietnam State Authority governing the import permit of medical device that requires import permit. Lawyers of law firm in Vietnam with experience in medical device should be consulted for the import licensing and sub-licensing process to ensure smooth experience.

1. Introduction about Medical Device

According to Circular No.30/2015/TT-BYT dated Oct 12th 2015 on importing of medical equipment, the term “medical device” is the types of equipment, tool, material and in-vitro diagnosis chemical and software used separately or combined with each other as indicated by the owner to serve people for one or a lot of purposes as follows:
a) Diagnosis, prevention, monitoring, treatment and mitigation of disease or injury compensation;
b) Checking, replacement, modification or surgery support and physiological process;
c) Life support or sustainment;
d) Conception control;
dd) Sterilization of medical equipment (not including chemicals and insecticides and disinfectants for domestic and medical use);
e) Use for medical equipment;
g) Special transport for medical activities.

2. How to import and trade Medical Device in Vietnam

In order to import the Medical Device, the importer has to strictly comply with Vietnam laws, especially setting up the trading company with the function to import and trade Medical Device.

Except those medical devices not yet permitted for use in Vietnam, trading medical device is considered as conditional business that the company must satisfy the following conditions:
a) Medical device must fully comply with the provisions of law;
b) Business entities must be traders defined in the Vietnam Commercial Law;
c) Business establishments must satisfy the requirements on techniques, equipment, facilities, business process and other standards prescribed by law; locations of business establishments must be in line with the planning on development of the network of establishments doing business with goods and/or services subject to conditional business;
d) Managerial and technical staff and employees personally engaged in the sale and purchase of goods, and employees personally engaged in the provision of services must satisfy the requirements on professional qualifications and experience and be physically fit according to the provisions of law;
e) Business traders must have certificates of satisfaction of business conditions in cases where such certificates are required by law to be granted by competent agencies.

3. Permit to import Medical Device

Further, for certain medical device belonging to the list which Vietnam Ministry of Health issues, the importer has to obtain the medical device import permit before importation.

Dossier for new issuance of Medical Device import permit includes:
a) A written request of issuance the permit as prescribed by law.
b) Valid certificate of free sale of types of imported medical devices at the time of submission of dossier.
c) The valid ISO 13485 or ISO 9001 quality systems certification (hereinafter referred to as ISO certification) of manufacturer at the time of dossier submission.
d) The valid Letter of authorization from medical equipment owner to organizations or individuals importing the medical equipment.
e) The technical material describing the types of medical equipment in Vietnamese language.
f) Catalogue describing the functions and technical parameters of types of imported medical equipment.
g) The clinical assessment material and manual of owner or manufacturer for the medical equipment specified in section 49 of Annex I issued with this Circular.
h) Report on result of import of medical equipment

The dossier will be addressed to the Ministry of Health (Department of Medical Equipment and Health Facilities) and they will review the completeness and validity of dossier within 05 working days. In case the dossier is complete and valid, a meeting of its consultation Council for issuance of medical equipment import permit will be held to review. The import will only be issued if there is no more requirement for modification or addition of import dossier from the Council. The validity of the import permit is until the validity of the letter of authorization and up to 01 year from the date of signature and issuance.

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10 QUESTIONS TO ASK BEFORE SETTING-UP COMPANY IN VIETNAM

Foreigners are encouraged to make investment in Vietnam through direct investment by Setting up company in Vietnam.

However there are restrictions in some cases in regard to investment capital, investment area, special licenses required. The investor is suggested to consult with a law firm in Vietnam for advice and service offering.

Before setting up business in Vietnam, ask yourself the following questions:

1. Which business should I invest in Vietnam?

There are non-conditional investment areas and conditional investment areas.  Establishing company in the non-conditional investement areas are more simple than in conditional investment areas.  Investment in IT services, manufacturing, management consulting, business promotion are a few samples of non-conditional investment areas.  Example of conditional investment areas are real estate, trading, travel agencies, freight forwarding…which are more complicated with investment conditions.  Investment conditions might also be changed over the time depending on the WTO commitments which Vietnam enters.

2. What should I name the business in Vietnam?
The company in Vietnam has to have Vietnamese name, and English name. The company could also have abbreviated name.  The name of the company in Vietnam indicates the structure of the company, the business lines, and the name that differentiate against other businesses.  For instance, the company could be named Alpha consulting limited liability company.

3. Where should I register the address of the business in Vietnam?
Not every address could be used to register a company.  The address has to be an address of a house with leasing agreement or office building which owner has license to operate as office building.

4. What is the legal structure of the company?
Depending on the number of investor contributing capital, company could be set-up as one member limited liability company or two ore more member limited liability company or joint stocks company.

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Forms of Investment in Vietnam

5. How much capital is required to set-up a company in Vietnam?
The investment amount depends on the business plan and is subject to the approval of the provincial Department of Planning and Investment evaluating application dossier. In some business areas like real estate, banking and finance, minimum capital is required. In general for non-conditional investment area, the law does not specify the minimum capital to establish a company in Vietnam however the State agencies that evaluate investment plan could reject the investment project which are not feasible. Bank statement in foreign banks could be used to prove sufficient fund of investment capital.

6. Whom will be legal representative and work permit in Vietnam?
The investor will need to appoint the legal representative in Vietnam to oversee the business performance and take legal responsibility in Vietnam. If the legal representative is an expatriate, whom is a capital contributing member or owner of a limited liability company or a member of the Board of Management of a shareholding company which is registered to operate in Vietnam, he or she will be exempted from work permit in Vietnam. Otherwise, he or she will need to have a work permit to work in Vietnam legally.  The work permit holder would then apply for temporary residence card to live in Vietnam as long as the work permit allows.

7. How long does it take to set-up a company in Vietnam?
It depends on what type, scale, and whether or not conditions are required. For a simple minimum capital without conditions to set-up, it would take 30 working days. For setting up company in conditional investment areas i.e.  trading company in Vietnam, time would be lengthen due to the involvement of a number of State agencies approving the investment project and it would take 60 working days. For setting up company in other investments in areas requiring conditions to meet, time might be taken depending on the type of conditions and the government agencies evaluating the conditions of investment.

8. Whom will be granting the investment license in Vietnam?
For most of the investment projects, the provincial state agencies with the approval of the Department of Planning and Investment (DPI) will be granting the Investment Certificate in Vietnam. However, depending on the type, scale, and whether or not conditions are required, other Vietnam State agencies might be involved. For the case of trading company, ministry of trade and commerce, ministry of finance, provincial people’s committee will be reviewing the investment application dossier as well.

9. What are the tax liability in Vietnam?
Major taxes in Vietnam are corporate income tax, import and export tax, value added tax, and personal income tax in Vietnam. In some special areas, there are other taxes. The corporate income tax is currently at 22% and will reduce to 20% beginning 2016. Export is mostly encouraged as such the export tax is 0 however there are special cases when export tax is larger than 0. Import tax varies according to tariff. Value added tax is mostly at 10% however in some cases, VAT could be 5% or 0%. Personal Income tax varies according to income level and is applicable from VND 9,000,000 above.

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Major Taxes in Vietnam

Personal Income Tax in Vietnam

10. What are mandatory reports submissions requirement in Vietnam?
Companies are required to keep accounting books, prepare and submit tax reports on monthly, quarterly and annually. Foreign companies are also required to have financial audit taken before the financial year end. The financial year in Vietnam is from January to December and the deadline to submit financial report is March 30th for the previous year. Other reports are required to be submitted at other State agencies.

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WHICH FORM OF INVESTMENT – BRANCH OR COMPANY?

Foreign entities can set-up company or branch offices in Vietnam to carry out business activities.

There are several main different aspects between opening a branch office or establishing a foreign owned company in Vietnam.

1. Conditions

• Permits for establishment of Vietnam-based branches of foreign enterprise shall each have a valid term of five years.
• Foreign enterprise must choose between establishing a 100% foreign capital enterprise or forming a joint-venture with domestic investor or company.

2. Certificate

• The Branch office needs to apply and obtain the operation license of a Branch;
• A foreign owned company will need to apply and obtain the investment certificate (“IC”) to operate in Vietnam.

3. Capital

• Optional, foreign entity will decide how much money to invest in branch. The allocation capital for branch is capital for the subordinate units.
• Mandatory, foreign entity will need to provide minimum capital as required by Vietnam Law in conditional investment area.

4. Obligation of owner

• For branch office in Vietnam, owner takes full responsibility;
• For company, owner takes responsibility within the capital contributed into the company in Vietnam;

5. Other matters

• For branch office setting up in Vietnam, the procedure is less complicated compared to those for the establishment of a 100% foreign owned company;  the branch office is able to carry out trading and some other activities as stipulated by Vietnam laws and the WTO commitments which Vietnam enters.  The business lines of a branch have to be aligned with the business lines of the headquarter of the foreign entity.
• Setting up foreign owned company would be more complicated than the setting up of the branch office, however this form of investment has more flexibility and freedom as it is a stand alone Vietnam entity recognized under Vietnam laws.

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TOP 10 CHALLENGES OF DOING BUSINESS IN VIETNAM

Expanding gross domestic product (GDP), modern infrastructure and a dramatic increase in foreign direct investment (FDI) are signs that Vietnam has transformed into an attractive investment destination, but there are still barriers to doing business which are best navigated with local help on board.

Since 1988, there have been 13,544 foreign investment projects with a total registered capital of US$213 billion in Vietnam, building a large overseas investment sector which occupies about 17% of GDP and 43.4% of industrial product value. Overseas firms are attracted by Vietnam’s 87 million-strong population which supports a large and young workforce and that has also seen an increase in disposable income in recent years.

Strong economic growth rates have been a common feature of the Vietnamese economy since the 1990s, and even though the high levels slumped slightly during the global financial crisis, the country has rapidly returned to pre-crisis growth trends and is expected to continue on this path. Infrastructure, tourism development, and related real estate and retail sector development in urban areas are all attracting large amounts of FDI, and overseas firms are increasingly attracted by the country’s move from a centralized to a market-orientated economy.

However, The World Bank and International Finance Corporation (IFC) rank Vietnam in 99th place in the world for ease of doing business, which means it is essential to seek local help of law firms and lawyers in Vietnam when expanding into the country.

Starting a Business

There are 10 procedures to undertake when starting a business in Vietnam, making it among the most complex start-up environments in the world. What’s more, many tasks facing new corporate entities may be unfamiliar to overseas companies, making the task far more rigorous. Registration of the seal-sample at the State Agency, for example, or publicly announcing the formation in a local newspaper are procedures most companies generally don’t have to complete.

Dealing with Construction Permits

It takes 110 days and 11 procedures to get permits for construction in Vietnam, once again requiring interaction with several official departments. Inspections must be carried out by the Department of Construction and the municipality, and certificates should be obtained from the Firefighters Prevention Department, the Department of Construction and the Department of Natural Resources and Environment.

Getting Electricity

Getting electrical connection is among the most rigorous tasks facing startups in Vietnam, taking 115 days to complete and costing a significant percentage of income per capita. Inspections by the local power corporation are required before completing processes with the Traffic and Transport Department and the Firefighters Prevention Department.

Registering Property

Registering property in Vietnam takes 57 days to complete, which is far higher than the OECD norm but around average for East Asia and Pacific. Contracts between the transferor and the transferee are signed before taxation is paid and registration for the right to use land is complete.

Getting Credit

Vietnam is home to quite a stable credit environment, and obtaining capital is a relatively smooth process for businesses. However, the lack of a private credit bureau can make the process a little trickier for overseas firms.

Protecting Investors

Investor protection is an area in which Vietnam needs to improve. It is ranked in 169th place by the World Bank and IFC, with a weak director liability index and shareholder suits index.

Paying Taxes

There are massive 32 corporate tax payments to be made each year which takes an average of 872 company hours to complete. Compared to the OECD norm of 176 and the East Asia and Pacific average of 209, taxation is one of the most burdensome processes of doing business in Vietnam.

Trading Across Borders

Given its strong manufacturing base and reliance on interconnectivity, trading across borders is a cheap endeavour. However, that isn’t to say the process is not complicated, and the stream of documentation required for both importing and exporting highlights that cross-border trade can be difficult at the best of times.

Enforcing Contracts and Resolving Insolvency

Enforcing contracts takes 400 days to complete and 34 procedures. Resolving insolvency is a far more laborious process, taking five years on average to complete and with a low recovery rate.

Culture

The Vietnamese believe in the teachings of the early Chinese philosopher Confucius which emphasize the importance of relationships, responsibility and obligation. Vietnam is also a collectivist country and community concerns will almost always come before business or individual needs.

ANT Lawyers

We have the local knowledge to help you navigate these minefields. Whether you want to set up in Vietnam or just want to streamline your Vietnamese operations, we could assist.

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CHANGE OF CHILD RAISING PERSON AFTER DIVORCE

When divorce, children raising issue is very important and is always considered by the parties. Typically, parents always want the best for their children. However, there are also cases that the person who is raising that child unable to provide comprehensive benefits for the child. Then the person who is not directly raise the child may request for caregiver to ensure human rights.

ANT Lawyers would advise to customers some of the content in the issue of stipulating caregiver and change of caregiver after divorce.

• The nursing, take care, educating and parenting after divorce

After divorce, parents are still obliged to look after, take care, educating, parenting minors or adults who are disabled, lost their civil act capacity, inability to work and have no property to support themselves.

The person who is not directly raises children have to provide rearing support.

Husband and wife agree on the person who directly raise the children, the rights and obligations of each party after divorce to their children; if no agreement is reached, the Court decided to assign one party to directly raise children based on the interests of that children in all aspects; if the children is nine years old or older, the wishes of the children must be considered.

In principle, children under three years of age are directly raised by the mother, unless the parties agree otherwise.

• Change the person who directly raises children after divorce

For the benefit of the children, at the request of one or both parties, the Court may decide to change the child directly raising people.

The change of child directly raising people after divorce is conducted in case the people who directly raise the child does not guarantee the rights of the child in all aspects. Moreover, if the child is nine years old or older, we have to take into consideration the aspirations of the child.

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CASES ARE REJECTED WHEN GET MARRIED WITH FOREIGN ELEMENT

The law of Vietnam prescribed quite detail about the marriage with foreign elements.

The registration of marriage with foreign elements will be rejected in the following cases:

– One or both parties are not old enough to get married under the laws of Vietnam

– The foreign applicant is not old enough to get married under the laws of the country of which he/she is a citizen or permanent resident (for stateless persons)

– The marriage between men and women is not due to a voluntary decision

– There is deception, coercion in the marriage

– One or both parties had husband or wife

– One or both parties had lost their capacity for civil acts

– The parties have the same direct blood line or relative within three generations

– The parties are or have been the adoptive parents and adopted children, father in law and daughter in law, mother in law and son in law, stepfather and his wife’s stepchild, stepmother and her husband’s stepchild

– The parties of the same sex (men marrying men, women marrying women)

– The marriage registration will also be rejected if the results of the interview, and verification showed that the marriage through illegal brokerage; sham marriage that is not intended to build prosperous, equal, progressive, happy and sustainable family; marriage is inconsistent with the fine traditions of the nation; taking advantage of marriage to trafficking of women, sexual abuse against women or for other self-seeking purposes.

Please contact ANT Lawyers via email ant@antlawyers.vn or call our Hotline for advices.

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CRIMINAL RECORD GRANTING FOR FOREIGNER

In order to be granted the work permit for foreigner, completing the immigration or reside procedures in a country, foreigners who are or have been residing in Vietnam must apply for a criminal record for the time that they residing in Vietnam.

Foreigners who are or have been temporarily residing in Vietnam have the right to request the Department of Justice of the province or city where they are residing or the National Centre for Criminal Record to issue the criminal record, in order to confirm that people have or do not have criminal records while residing in Vietnam. The person requesting for criminal record card can authorize another person on their behalf to complete procedures to obtain the criminal record.

ANT Lawyers can assist clients to apply for: Criminal record card no 1 and Criminal record card no 2

Individual when requesting for criminal record issuance have to provide the following documents:

• For Vietnamese:

– A written declaration requesting for the issuance of criminal record;

– Certified copy of identity card, passport, family record book, temporary residence book, temporary residence card, permanent resident card in Vietnam (should present the original for comparison);

– Confirmation of permanent residence in Vietnam before leaving the country (applies to Vietnamese who are living in foreign countries).

• For Foreigner:

– A written declaration requesting for the issuance of criminal record;

– Copy of the passport and visa that are still valid;

– Confirmation of temporary residence in Vietnam.

Implementation time: 3-7 working days.

Please contact ANT Lawyers for advice.

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