Litigation lawyers in Vietnam: Medical Device Lawyer in Vietnam

Hiển thị các bài đăng có nhãn Medical Device Lawyer in Vietnam. Hiển thị tất cả bài đăng

Thứ Năm, 16 tháng 3, 2023

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 firms 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 set 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.

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 law firm in Hanoi, law firm in Ho Chi Minh City and law firm in Da Nang.

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Trading Conditions on Medical Device in Viet Nam

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

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 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 device 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 device, the enterprise shall declare applicable standards for Type A medical device or issue certificate of free-sale registration for Type B, C, D medical device. This procedure makes sure that medical device 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 device according to its manual. In addition, trading premise shall have suitable transportation vehicles for delivering of 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

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 Law firm in Hanoi, law firm in Ho Chi Minh and Law firm in Danang.

Finding the right business partner in Vietnam is also important. We recommend doing research on the reputation of the company and individual shareholders, corporate or individual, gathering publicly available company information, and performing background checks on key personnel to find potential risks in cooperation. Working with a reliable partner can help achieve economic benefits, saving time and money in business.

How Foreigners Could Marry Vietnamese Wife?

When a foreigner marrying a Vietnamese, this is cross cultural marriage with challenges and complexity in relationships which could be legally difficult. The Vietnam laws on Marriage and Family on marriage and family relations involving foreign elements provide legal grounds to avoid false marriages to gain citizenship or conduct human trafficking.

The following should be taken into consideration when a foreigner marrying a Vietnamese. However due to the complexity, it is suggested family lawyers in Vietnam to be consulted to ensure the correct processes and procedures are carried out in timely manner:

Marriage consultation:

If marriage registration between a foreigner and a Vietnamese belongs one of the following cases, Vietnamese citizen must be consulted by the provincial Marriage Consultancy Center: i) the age gap between two partners is 20 years or more; ii) this is the third marriage of the foreign partner, or the foreign partner has gone through a divorce with a Vietnamese citizen; iii) the partners do not completely understand about the families and backgrounds of each other; about the languages, traditions, customs, cultures, and laws on marriage and families of each other’s country.

After being advised on marriage consultation, Vietnamese citizen will be issued a certificate by Marriage Consultancy Center (hereafter referred to as Certificate) which is part of the application dossier.

When the Vietnamese citizens is fluent in a foreign language or foreigner is fluent in Vietnamese, and the interviews at the Justice Department show that both sides have an good understanding of family circumstances, personal situation, and the understanding of language, customs, traditions, culture, laws on marriage and family in each country, the Certificate will not be needed.

Submission for marriage registration

One of two parties would submit directly to provincial Department of Justice of province where the Vietnamese citizen applicant resides. A dossier of marriage registration is prepared including the following papers of each party:

a) The marriage registration declaration (standard form);

b) The papers of marriage status of each party:

Vietnamese shall provide the written certification of marital status issued by the People’s Committee where he/she resides.

Foreigner shall provide the documentary evidence on marital status of foreigners issued by a competent agency of the country of which the applicant is a citizen. In cases where foreign laws do not prescribe the certification of marriage status, it can be replaced by the certification of oath taken by the applicant that he or she concurrently has no wife or husband, in accordance with the laws of those countries; the written certificate of marriage eligibility issued by a competent agency of the country of which the applicant is a citizen (unless laws of this country do not regulate about this document); for foreigners who have already been divorced with Vietnamese citizens at foreign competent agencies, they must submit the written confirmation that the divorce which carried out abroad have been recorded in civil status book as prescribed by law of Vietnam.

c) The medical examination from a Vietnamese or foreign competent health organization, certifying that such person does not suffer from mental diseases or other diseases which make a person incapable to aware or control his/her acts;

d) Copies of personal papers, such as identity card or passport, passport or papers of substitute value such as travel document or residence card;

e) Copies of the household registration book, the temporary residence book (for Vietnamese citizens living in the country); permanent residence card, temporary residence card or temporary residence certificate (for foreigners residing temporarily or permanently in Vietnam).

f) Certificate of Marriage Consultancy Center on marriage to a foreigner that Vietnamese citizens have been given advice for marriage in compulsory cases mentioned above.

All documents provide by parties have to have valuation within 6 months to the date when the dossier is received.

Interviews for marriage registration to a foreigner in Vietnam

Within 15 days as from the date of receiving the complete and valid dossiers as well as fees, the provincial Department of Justice shall have the responsibilities to implement the direct interview at head office for both marriage partners in order to check, clarify personal matter, voluntary marriage and extent of understanding each other of both marriage partners.

If the interview result shows that two parties fail to understand status of each other, the provincial Department of Justice shall make an appointment for re-interview; the next interview shall be performed 30 days after the preceding interview.

In cases there are issues which need to be verified, the provincial Department of Justice shall carry out necessary procedures to verify.

Certificate of marriage registration in Vietnam

After interviewing both marriage partners, studying and verifying the marriage registration dossiers, opinions of police agencies (if any), the provincial Department of Justice shall report result and propose settlement of marriage registration to submit to provincial People’s Committees for decision, enclosed with 01 set of marriage registration dossier.

Within 05 working days, after receiving the written submission of the provincial justice department together with the marriage registration dossier, the chairman of the provincial People’s Committee shall sign in the certificate of marriage and return dossier to the provincial Department of Justice for holding the ceremony for marriage registration.

In case refusal for marriage registration, provincial People’s Committees shall have a document clearly stating reasons thereof and send it to the provincial Department of Justice in order to notify both marriage partners.

Ceremonies for marriage registration in Vietnam

Within 05 working days, after the Chairman of the provincial People’s Committee signs the marriage certificate, the provincial Department of Justice shall hold ceremony for marriage registration.

The marriage registration ceremony shall be solemnly organized at the office of the provincial Department of Justice. When the marriage registration ceremony is held, both marriage partners must be present. The representative of the provincial Department of Justice shall preside over the ceremony, requesting both parties to state their final intention on voluntary marriage. If they agree to marry each other, the representative of the Department of Justice shall record the marriage in the marriage registers, requesting each party to sign on the marriage certificate, the marriage register and hand over the original marriage certificate to the husbands and wives, each with one certificate.

The marriage certificate shall be valid from the date the marriage registration ceremony is organized as provided. The grant of copies of the marriage certificate from the original registers shall be implemented by the provincial Department of Justice at the requests of the wives or husbands.

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.

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.

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

Medical Heathcare Industry

The demand for medical equipment in Vietnam has been increasing due to the need to for treatment for cancer, heart disease, injuries, with focus on imaging equipment, operation room, emergencies resuscitation, intensive testing. The reason behind is the rising income and awareness of treatment for better quality of life. The foreign companies also tend to seek market entry solutions from independent consultant or local partners whom will be distributing the products into Vietnam to maximize the success chance.

In 2012, the size of medical equipment and supplies had been estimated by Ministry of Health at USD 515 m and the growth rate is between 10-11% per year.

However, the market development has been faster than anticipated. In 2016, total investment in medical equipment in Vietnam was USD 950 million USD. By 2017, this figure increased to USD 1.1 bil and that growth rate has been 18% over the past 5 years.

It has been reported 90% of equipment and supplies are imported from Japan, Germany, USA, China and Singapore, the 3 leading countries are United States, Germany and Japan. The imported imaging equipment such as magnetic resonators, CT machines, ultrasound machines, x-ray machines accounted for 30% of the import volume.

The Ministry of Health has policy to improve the capacity of medical equipment production in Vietnam over the last 20 years ago but the success is limited. Currently, there are about 50 domestic enterprises, but mainly produce medical bed and cabinet. The more advanced machines are being assembled by enterprise that cooperate with Japanese and Korean partners.

It has been evaluated that medical equipment is one of four attractive sectors for foreign investors when targeting Vietnam, in addition to investment in electronics, IT and communication and textiles. Public hospitals, which account for 70% of the market share, are still the largest customers of these manufacturers. The remaining other customer groups include foreign invested hospitals, private hospitals and research institutes, universities.

Government investment capital will continue to play an important role and public hospitals will tend to be more self-reliant in seeking financing for medical equipment investments.

For foreign companies entering Vietnam for supplying medical equipment, they have to follow strict process for bidding for public service. It is important for the foreign medical equipment to follow the Vietnam law and undertake regulatory investigation and research on medical equipment there are different implications for the import, sales and distribution into Vietnam.

Pharmacy and Healthcare in Vietnam

1.Overview

There has been an optimistic trend in pharmacy and healthcare industry in Vietnam. This industry is irreplaceable as the education level and life expectancy of Vietnamese have been significantly improved. However, due to some challenges, pharmacy and health care industry desires for a change in legal framework, thus creating favourable conditions for development in the futures.

2.Vietnam – next growing pharmacy and healthcare market

-Overview of market potential

With the population of around 94 million, 44% monthly increasing income, 30% urbanisation rate with 3.4% growth rate per year, 6% GDP growth per year, the demand for better development of pharmacy and healthcare industry has been significantly increased.

Medical Device Law Firm in Vietnam

Law firms in Vietnam

Business Monitor International (BMI) in their report “Vietnam Pharmaceutical and Healthcare” revealed that annual total value of pharmacy market $3 billion with annual growth of 15.5% period 2014-2018. The same report also showed that the total healthcare spending reaches $13 billion in 2015 which account for 5.8% GDP- highest in ASEAN, is expected to grow to $24 billion in 2020s.

-Trade agreement influence Vietnam’s market

Vietnam has recently taken part in several trade agreement which allow foreign companies to easily enter Vietnam. Firstly, Vietnam has cut tariff on 47 tariff lines of pharmaceuticals. Also by encouraging foreign investment to enter Vietnam in various forms, among 171 pharmaceutical companies operating in Vietnam, 9% are foreign invested enterprise, 4% are joint ventures.

Secondly, in terms of healthcare sector, the data of Ministry of Health stated that there are 137 operational private hospitals, including six foreign invested hospitals, and about 30,000 consulting rooms. These six foreign invested hospitals have the initial investment capital of 94 million dollars. Vietnamese government had licensed to a lot of foreign invested projects in the healthcare sector which included a total investment capital of 1.16 billion dollars. In addition, the government has allowed the investors in healthcare sector to enjoy 10% corporate income tax for the whole life of the project, tax exemption for 4 years and lower land leasing fee for years.

-Pharmaceutical products heavily rely on import

Local pharmaceutical production was valued at nearly US$920 million which satisfy 48 % of the needs in Vietnam. Imported drugs account for the remaining 52 %. Vietnam imports pharmaceuticals mainly from France, India and Korea. The medicine lines from this countries is stable and price competitive. In terms of domestic companies, the three largest public pharmaceutical companies are DHG Pharmaceuticals JSC (DHG), Traphaco JSC (TRA) and Domesco Medical Import-Export JSC (DMC).

Around 90 of raw material input are imported from foreign countries, in which 57% are from China, 18% from India and other countries such as Austria, Spain, Germany, France, Italy, and Sweden …

-Vietnam’s consumer behaviour

Vietnamese consumer has a strong preference of foreign medicines. The statistics have revealed that in the doctor prescription, 18 -20% domestic medicines are used for the patients even though the imported medicines are more expensive than domestic ones. Vietnamese consumer has more confident in terms of quality of foreign products.

Only 20%-30% of Vietnamese consumers buy medicines with prescription. However, BMI expected that the usage percentage of medicine through prescription will increase to 74.6% in the next 5 years.

3.Challenges

-Poor regulation standards

Price management and intellectual property protection of the government have not been managed closely. Therefore, the price of products still increases every year and the counterfeit medicines is still floating in the market, around 0.1% in 2012 (Drug Administration of Vietnam)

Around 28% of pharmaceutical companies have the Global Manufacturing Practice (GMP) certification, which states the minimum requirements that a pharmaceutical manufacturer must meet in order to prove that their products are of high quality and do not pose any risk to consumers. Particularly, in 2013, there are 79 out of 105 foreign medicine manufacturing enterprises and 5 of 80 domestic manufacturing enterprises that qualify GMP due to the fact that most of the enterprise are small in terms of sizes and capital investment. This indicates that Ministry of Health needs to take more aggressive actions to encourage the companies to meet the standards.

-Specific patented medicines is weak

Even though there are plenty of investment projects in pharmaceutical and healthcare industry with support from government, producing patented medicines are still too expensive in terms of time and manpower. In fact, lack of medical qualification, infrastructure development and material sources are factors leading to underdeveloped circumstance in this sector.

-Lack of accessibility in healthcare industry

There has been 1090 public hospital and 175 private hospitals in Vietnam in 2014, is expected to increase to 1204 and 200 respectively. However, there are 25.1 hospital beds per 10,000 inhabitants and 7.9 doctors per 10,000 inhabitants, which are still a question mark that has not been handled.

How ANT Lawyers Could Help Your Business?

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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

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.