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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Swedish firms look to spur investment in Vietnam

HCMC – Several leading Swedish businesses expressed their intentions to expand investment in Vietnam during a meeting with Prime Minister Nguyen Xuan Phuc in Stockholm on May 27.

Most of the participating companies, including Electrolux, Oriflame, Scania, ABB, Ericsson, Tetra Pak, and Volvo, have already been investing in Vietnam for many years, reported the Vietnam News Agency.

Foreign InvestmentLawyers in Vietnam

In his opening speech, the Vietnamese leader spoke highly of the Swedish firms’ prestige in the global market, including Vietnam.

Phuc said that the Swedish government and its people have offered considerable assistance to the Vietnamese people during the fight for national independence in the past, as well as its course of development.

He expressed his hope that Swedish businesses will further invest and apply new, cutting-edge technologies in Vietnam, as well as engage in the country’s social and economic development process.

Leaders of Swedish companies expected the European Union-Vietnam Free Trade Agreement (EVFTA) to be signed soon, thereby facilitating Swedish trade with Vietnam.

Jonas Samuelsson, president and chief executive officer of Swedish multinational home appliance manufacturer Electrolux, said that Vietnam is the most important market of the group in the Association of Southeast Asian Association, bringing in annual revenue of US$150 million.

He said Electrolux is seeking opportunities to boost its business in Vietnam since the country is showing its support for an open and free trade system, which is also a general trend in Asia.

Håkan Buskhe, president and CEO of Swedish aerospace and defense company Saab Group active all over the country, said that Saab spends a quarter of its revenue into the research and development sector on a yearly basis.

He added the group has partnered with Vietnamese firms in airspace and seaport management, so it stands ready to transfer its technologies to them.

Swedish multinational networking and telecommunications giant Ericsson has established its foothold in Vietnam since 1993, according to the company’s executive vice president Fredrik Jejdling.

Jejdling revealed that the company would coordinate with Vietnamese military-run telecom firm Viettel to develop the fifth-generation (5G) network service. This would help upgrade G5 infrastructure, enabling the country to adopt Internet of Things solutions.

He pledged to support Vietnam in developing the innovative network through software and technological solutions.

Johan Söderström, managing director for ABB in Sweden that has been operating in the Southeast Asian nation since 1993, expressed his desire to boost solutions about innovation and sustainable development, including robot technology.

He also showed a strong commitment to bolstering cooperation with Vietnam, especially in developing the electricity grid network.

PM Phuc affirmed that Vietnam’s competent agencies would provide the best possible support for Swedish businesses to expand investment. He also promised to canvass their opinions and remove obstacles so that these major companies can help bring advanced technologies to Vietnam.

As a gateway of ASEAN markets and with many new-generation free trade agreements already or about to be signed, Vietnam is an open market for Swedish enterprises, the PM added.

How ANT Lawyers Could Help Your Business?

Please click here to learn more about ANT Lawyers Foreign Investment Practice or contact our Law firms in Vietnam for advice via email ant@antlawyers.vn or call our office at +84 28 730 86 529

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Simplifying the Procedure for Foreigner to Reside in Vietnam

For foreigners wishing to come to Vietnam to work and reside temporarily, they need to either set-up a company in Vietnam or work for others. The owner of the company does not need a work permit but still need to apply for temporary residence card.

However, the foreign employee will need the employer to sponsor the work permit in Vietnam before applying for temporary residence card. A recent draft law on entry, exit and residence of foreigner in Vietnam has been proposed with some changes. The draft regulates many open provisions on entry-exit procedure, temporary and permanent residence conditions for foreigner to reside in Vietnam. ANT Lawyers always follows the new updates about administrative procedures in Vietnam to provide our client with the best service.

The new draft law details conditions for granting the temporary residence card for foreigners working in Vietnam, rising term of this card from 3 year to 5 year. The foreigners’ category expands to scientists and specialists residing in Vietnam for the purpose of attracting international talents, the foreigners who don’t have any type of document proving nationality, and have resided in Vietnam before the year 2000. The foreigners holding temporary residence card must change card per periodically 10 years at the issuing offices. The draft law does not allow the foreigners to change the entry purpose, but allows them to supplement the purpose of belonging persons in some specific cases such as in term of diplomatic representative offices, consulate, international representative office of United Nations and students at universities, colleges, schools.

For more information or requirement of legal services to obtain temporary residence card in Vietnam, we could assist. 

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Visa, Work Permit and PIT – What Enterprises Should Consider When Employing Foreign Workers in Vietnam | Law Firms In Vietnam

Enterprises employing foreign workers in Vietnam should be aware of issues on visa, work permit, liability of enterprise related to Personal Income Tax (PIT) of the foreign employee as declaration, payment and finalization to ensure legal compliance.

Visa

Foreigners eligible working in Vietnam are foreign investors whom contribute capital to set-up company in Vietnam, chief representative of NGO, lawyers licensed by Vietnam Ministry of Justice, foreigners workers with valid working permits in Vietnam. Working visa in Vietnam is granted to foreigner working legally in Vietnam. Working visa for foreigner in Vietnam has maximum length of 12 months. In the case the foreigner wishing to stay longer, he/she could apply for temporary residence card for a period of up to three years. The application must be submitted to the provincial Immigration Department, and may include supporting documents such as a housing lease contract and an employer’s certificate of incorporation.

Work permit

Decree No. 102/2013/ND-CP elaborating some articles of the Labour Code on foreign workers in Vietnam states that for foreigners that requires work permit in Vietnam, the employing enterprises will have to apply for work permit for such employee before they start working. The head of the provincial People’s Committee will have to approve the necessity to hire foreigners before the Vietnam Department of Labour, Invalid and Social Affairs (DOLISA) grants work permit in Vietnam. For foreigners belonging to one of the cases exempted from work permit, the employing enterprises will have to request the provincial DOLISA where foreign workers regularly work to certify that such foreign workers are exempted before the day on which they start to work.

Personal Income Tax obligation

Foreigners whom are subject of Personal Income Tax (PIT) in Vietnam are resident and non-resident workers. Foreigners who reside in Vietnam for less than 183 days in a tax year are considered non-residents for tax purposes. The first tax year is the consecutive 12 months period from arrival date in Vietnam, and the second tax year will follow the calendar year. Non-resident foreigners working and earning income in Vietnam are subject to PIT at a flat rate of 20%. Foreigners who reside in Vietnam for 183 days or more in a tax year are considered tax residents in Vietnam and subject to PIT at progressive rates on their world-wide employment income. Incomes of foreign workers in Vietnam are based on salaries, wages, allowances and other benefits such as housing allowances, memberships at sport and health clubs, personal entertainments. The expenses not being subject to PIT are including return air tickets between Vietnam and home country of the foreigners, school tuition fees of children of foreigners which employing enterprises pay on their behalf.

Vietnam has signed double tax agreements (DTA) with a number of countries, in which tax exemptions may be applied in specified circumstances. To request for tax exemptions, the application has to submit the request to the Ministry of Finance.

How ANT Lawyers Could Help Your Business?

Please click here to learn more about ANT Lawyers Civil Matters Practice or contact our Law Firms in Vietnam for advice via email ant@antlawyers.vn or call our office at +84 28 730 86 529

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