Conditions for Establishing Representative Office in Vietnam

 Decree No. 07/2016 / ND-CP regulating the Commercial Law regarding representative offices and branches of foreign traders in Vietnam that have recently been issued by the Government.

Accordingly, foreign traders can establish their representative offices and branches in Vietnam under Vietnam’s commitments in international treaties to which Vietnam is a member. A foreign trader cannot establish more than one representative office or branch with the same name within a province or city under central authority.

Foreign traders are licensed to establish representative offices when they meet five conditions:

– Foreign traders can establish and register for business in accordance with law of nation and territories participating in international treaties in which Vietnam is a member, or recognized by the law of those nations and territories.

– Foreign traders that have been in operation for at least one year from the date of establishment or registration.

– In case the certificate of business registration or papers with equivalent value of the foreign traders have prescribed the time limit for operation, then the duration must be at least 1 year from the date of submitting record.

– The operation of the representative office must match the commitment of Vietnam in the international treaties in which Vietnam is a member.

– The case where the operation of the representative office is inconsistent with Vietnam’s commitments or foreign traders do not belong to any nations and territories participating in the international treaties in which Vietnam is a member, the establishment of representative offices must be approved by the Minister of specialized management.

The Decree also stipulates the conditions for foreign traders to be granted licenses to establish their branches. Specifically, foreign traders will be licensed for the establishment of branches when they meet 5 conditions:

– Foreign traders can establish and register for business in accordance with law of nation and territories participating in international treaties in which Vietnam is a member, or recognized by the law of those nations and territories.

– Foreign traders that have been in operation for at least five year from the date of establishment or registration.

– In case the certificate of business registration or papers with equivalent value of the foreign traders have prescribed the time limit for operation, then the duration must be at least 1 year from the date of submitting record.

– The operation of the branch office must be consistent with the market-opening commitments of Vietnam in the international treaties in which Vietnam is a member, and in line with the business lines of the foreign trader.

– If the content of the branch operation is inconsistent with Vietnam’s commitments or foreign traders do not belong to any nations and territories participating in the international treaties in which Vietnam is a member, the establishment of branches must be approved by the Minister of specialized management.

The license for the establishment of representative office and branch of foreign traders have a term of 5 years but does not exceed the remaining term of the certificate of business registration or papers of equivalent value of the foreign trader in the case that those papers contain provisions on the term.

We help clients overcome cultural barriers and achieve their strategic and financial outcomes, while ensuring the best interest rate protection, risk mitigation and regulatory compliance. ANT lawyers have Attorneys in Hanoi, Attorneys in Ho Chi Minh and Attorneys in Danang.

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Vietnam and Japan Signed 12 Cooperation Agreements

 The Secretary General of Liberal Democratic Party of Japan, the President of Japan – Vietnam Friendship Parliamentary Union- Nikai Toshihiro, on January 12th, 2020 met with the Vietnam’s Prime Minister- Mr. Nguyen Xuan Phuc in Hoi An to discuss economic, cultural and tourist exchange topics.

At the meeting, the representative of Vietnam welcomed the Japanese delegation to come and exchange of economic, cultural and tourism exchanges of the two countries. The representative of Vietnam affirmed that Vietnam appreciate the cooperation with Japan, especially in economic matters. At the moment, Japan is the top country with FDI in Danang in particular and Vietnam in general. The Japanese investors set up company, obtain investment registation certificate and invest in various business lines including IT, trading, real estate, design consultancy, engineering. Based on the cooperation between the countries, Vietnam and Japan have achieved many positive effects on the economy, education, culture, social security.

The representative of Vietnam confirmed that the relationship between the countries developed into many fields as “extensive strategic partnership for peace and prosperity in Asia” established in 2014, in which, Japan always is the trustful, important partner of Vietnam.

The representative of Japan expressed his pleasure to visit Vietnam in the beginning of 2020. He said that the organization of the delegation has the largest scale ever with more than 1,000 delegates, and diverse members from National Assembly deputies, representatives of ministries, branches, local leaders, businesses and people of Japan showed high interest and consensus within Japan from the National Assembly, the Government, localities, business community and people towards strengthening and deepening friendly and cooperative relations with Vietnam in the coming time.

By this meeting, the representatives of the two countries witnessed the signing and exchange of 12 cooperation documents, memorandums of understanding between ministries, branches, localities and businesses of the two countries. By these cooperation documents, the two countries hope that in the future, they will cooperate more together in all aspects of culture, education, economy and society to realize their construction goals and develop the countries.

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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.

How ANT Lawyers Could Help Your Business?

ANT Lawyers is a law firm in Vietnam located in the business centers of Hanoi, Danang and Ho Chi Minh City. We provide convenient access to our clients. Please contact us to book your time in advanced to let us provide our best service.

Call us at +84 28 730 86 529 or send us email ant@antlawyers.vn

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