Medical Devices Compliance in Vietnam: A Case Study from Medical Equipment Distribution Companies

As healthcare spending in Vietnam increased over the years, the need for medical devices compliance has grown. By 2030, Vietnam’s healthcare expenditure will reach US$33.8 billion, up from US$16.1 billion in 2017. In 2025 itself, the forecasted spending is US$23.3 billion. Earlier, the World Bank had predicted that the Vietnamese healthcare market will increase threefold in the 2010–2020 decade, which is visible in the way it has outperformed countries like Thailand and Malaysia.

However, the healthcare scene in the country is plagued by a lack of adequate medical tools, a fact most medical equipment distribution companies acknowledge. This is especially true for outdated surgical equipment. Although the health-related issues of the Vietnamese population have boosted medical spending, still a lot of investment is needed, especially in importing new equipment. 

In this article, we have given a thorough insight on how medical device compliance is done in the country, including the classification and registration of the devices. InCorp Vietnam helps medical equipment manufacturers acquire the necessary registration for their devices as per Vietnamese regulations. On average, Vietnamese people spend US$2 billion every year to travel overseas in the lookout for better treatment, a gap that can be utilized by foreign companies.

Need Assistance? Learn About InCorp Vietnam’s Medical Device Registration Services

Definition of Medical Equipment

As per Vietnamese government circulars, medical equipment or medical device is defined as software, diagnostic chemicals, materials, and tools that can be used in combination or separately for the following purposes:

• Supporting or modifying surgical or physiological processes
• Checking or replacing surgical processes
• Diagnosing, monitoring, treating and preventing diseases and injuries
• Supporting and sustaining life
• Sterilizing medical equipment other than insecticides and chemicals
• Disinfection of equipment
• Control of conception
• Helping in the transport of medical activities. 

In Vietnamese medical devices compliance, the term “medical equipment/device” has a broad application. It can be any tool that is used to diagnose, treat, prevent or mitigate disease or abnormal health conditions. This differentiates medicines from medical devices. This is in line with how the World Health Organization’s Global Harmonization Task Force (GHTF) defines medical devices. As such, medical equipment distribution companies in Vietnam supply three types of devices

• Simple devices like stethoscopes, thermometers, and bandages.
• Intermediate devices like nebulisers, blood glucose meters, and hearing aids.
• Complex devices like surgical robots, pacemakers, and MRI scanners. 

Medical Equipment Classification

The ASEAN Medical Device Directive (AMBDD) and the Global Harmonization Task Force of WHO classify medical equipment in the following categories, which are also followed by the Vietnamese government. 

• Class A: These are low-risk medical equipment like hospital beds, surgical gloves, cotton, bandages, etc. Medical equipment manufacturers need not bother about licenses to supply these. 
• Class B: Low-moderate-risk medical devices like electronic thermometers, pregnancy kits, breathing masks, etc. fall under this category. 
• Class C: This includes high-moderate-risk medical equipment like implants, electric scalpels, condoms, etc. 
• Class D: This category is reserved for high-risk medical devices like artificial bones, surgical kits, antibacterial gauze, etc. Medical equipment distribution companies need to have a license to manufacture and sell these products, as they require quality control and precision along with highly trained personnel diligently following certified processes. 

In Vietnam, medical devices are also classified as per the Food and Drug Administration (FDA) guidelines. This includes the following three categories of medical equipment:

• Class I : These are common, low-risk, and low-complexity equipment like hand-held surgical instruments, examination gloves, elastic bandages, dental floss, etc. 
• Class II: This category includes partially implanted more risk to patients complex devices like powered wheelchairs, infusion pumps, syringes, computed tomography scanners, etc. 
• Class III: Fully implanted, greater-risk medical devices like blood sampling monitors, breast implants, defibrillators, and pacemakers come under this category. 

The Vietnam Medical Equipment Association recommends that foreign investors looking to set up medical companies follow Annex 1 of Circular 30/2015/TT-BYT in addition to the above classification system.

While Class A and B medical devices are approved immediately, the review time for Class C and D equipment takes more than a year at times. Foreign companies also need to keep in mind the license fee for each class of medical devices

• VND 1 million or US$40 for Class A instruments
• VND 3 million or US$120 for Class B instruments
• VND 6 million or US$240 for Class C instruments
• VND 6 million or US$240 for Class D instruments

Additionally, foreign investors should be aware of the following classification rules followed by the Vietnamese government to grant licenses: 

• The classification is done as per the risk of the equipment
• If a medical device intended for a particular purpose has more than one risk level, it is classified according to the highest risk level. 
• For instruments with multiple uses and risk levels, the same highest risk classification rule is followed.
• If a medical device is designated to be used with other devices, then each of them has to be separately classified.

Read More: Mastering Medical Device Registration: Your Key to Success in Vietnam

Medical Equipment Registration in Vietnam

Vietnamese regulations mandate that medical devices compliance follow different registration procedures for different classes of equipment. As per, the Ministry of Health’s Department of Medical Equipment and Health Works (DMEHW). All medical equipment distribution companies need to abide by strict criteria to get a license to sell their products.

For Class A and B instruments, medical equipment manufacturers must submit the “Declaration of Applied Standard” to the nearest branch of the Health Department, which will authorize them to sell the product for 1-3 months by providing a marketing authorization code (MAC).

Meanwhile, for Class C and D instruments, a Declaration of Applied Standard should be submitted at the local health department, which will grant you a MAC code to sell the products for 6–12 months, with a provision to extend it to 18 months. 

To get the license for Class A devices, you have to submit the following:

• Original classification copy issued by a Vietnamese lab 
• ISO 13485 certificate from the Vietnam Embassy
• Letter of authorization
• Warranty certificate 
• Declaration of conformity
• E-signature of the product-license-holder-company
• Certificate of Free Sale (CFS)
• Description of the medical equipment written in Vietnamese language
• Instruction manual
• Sample of the product label in a good-quality PDF file

To get the license for Class B, C, and D devices, you have to submit the following:

• Original classification copy issued by a qualified Vietnamese lab
• ISO 13485 certificate written in English issued by the Vietnam Embassy
• Letter of authorization
• (POA) The Owner of Product authorizes the Company in Vietnam to be a license holder
• Description of the equipment in Vietnamese language
• CFS
• Instruction manual
• Catalog
• A good-quality PDF file of the original label 

Foreign companies should take note of the quick registration and emergency registration procedure of Class C and D medical devices, which grants you approval in 10 days instead of the regular 45-day wait. The quick method applies to equipment with authorization from the US FDA, Medical Devices Agency of Japan, Health Canada, Therapeutic Goods Administration of Australia, UK or Chinese state agency, etc., along with a license to import to Vietnam. Meanwhile, the emergency method is applicable for products meant for epidemic prevention or those used to contain disease outbreaks in natural disasters as authorized by the WHO or EU Health Security Committee.

Import and Distribution Requirements for Medical Equipment Manufacturers

Foreign medical equipment manufacturers must fulfill certain import and distribution parameters set by the Vietnamese government to sell their products in the country. 

The first and foremost parameter for medical device compliance is to acquire MA licenses. This should be done by the regional branch of the foreign company, but in case you don’t have a representative office (RO) in Vietnam, then partner with a Vietnamese distributor. Corporate consultancies like InCorp Vietnam can help in the process either by getting you an RO or by finding a distributor for registration.

Additionally, it should be noted that Vietnamese companies having an import authorization Vietnamese registration are allowed to sell medical equipment in the country. Hence, foreign firms must have a local office or sell through a regional distributor. These Vietnamese companies foster better connections with local clients and help you with market research.

As per Decree 98 issued by the Vietnamese government, any medical instrument without a registration number needs an import license. This is applicable to all medical devices used for diagnosis, tests, trials, scientific research, training, and quality assurance. Instruments used for epidemic prevention and control, national defense, and those displayed at exhibitions and fairs are also part of this. 

Comparison between Two Trends of Clients

Vietnam takes medical device compliance issues seriously, and hence foreign medical equipment distribution companies should understand the consequences of it. Here is a comparison of medical equipment manufacturers with and without licenses.

• A license holder gets the right to import and distribute the devices and also change their local distributor according to their preferences. Whereas a non-license holder depends on third parties or distributors to sell their products.
• While the license holder has to establish a Representative Office (RO) or Limited Liability Company (LLC), the non-license holder can operate through a distributor or a third party.

Medical Equipment Purchasers

Foreign medical equipment manufacturers should keep in mind the following categories of buyers to avoid any medical device compliance issues. In Vietnam, there are essentially four types of medical equipment purchasers:

Government Hospitals, Clinics and Health Centers

Around 70% of the medical equipment used in Vietnam is purchased by public hospitals and healthcare facilities. Foreign companies can sell their products in these centers if they tie up with a local partner. It is more lucrative for foreign medical equipment distribution companies to sell their products in government healthcare centers as they have the ability to buy sophisticated devices due to government aid.

Private Hospitals

As the healthcare market increases in Vietnam, more and more private hospitals are opening up. These places use the latest medical devices to lure people away from government-run hospitals by offering better healthcare facilities.

Foreign-owned Hospitals and Clinics

Large multispecialty hospitals supported by foreign companies acquire advanced medical instruments from sponsoring countries, leveraging their larger budgets to access the latest healthtech innovations.

Research Institutes

These are medical institutions that indulge in high-end, cutting-edge medical technology, including equipment for research on different diseases and ailments. It is a playing field for medical equipment manufacturers, as they can test their latest inventions in these institutions. 

Common Risks for Medical Devices Investors

Most foreign investors entering the Vietnamese healthcare market often make mistakes in submitting documents for product classification. It is vital that documents are prepared keeping in mind business conditions and the category of classification. Any error in the documents, including missing or incorrect information, can delay the authorization and medical device registration process. Additionally, foreign firms might face medical device compliance issues if the products expire the ISO in the home country.

Manufacturers need to ensure that all documents are valid and legalize them before submitting. Failure to do so can result in a year-long delay of the authorization. High-risk medical devices like Class C and D instruments have to undergo clinical trials on humans to ensure the safety of the products. 

List of Medical Equipment Companies in Vietnam

Here are some examples of well-known medical equipment distribution companies in Vietnam:

Vinamed JSC

The top medical equipment manufacturer in Vietnam is Vinamed JSC, or Vietnam Medical Equipment Corporation, which has been in business for 30 years. This company has a highly experienced expert team of trained pharmacists, biomedical engineers, and economic management staff who are dedicated to creating high-quality equipment, chemicals, and machinery. The company has reputed pharma clients like Maquet and Weimann.

Ho Chi Minh City Medical Technical Services JSC

This 1975-established state-owned medical equipment factory is part of the Ho Chi Minh City Health Department. The company has highly qualified and experienced workers who oversee large-scale projects involving several hospitals and healthcare centers in the city. Their medical equipment is used by hospitals across the country. 

J&V Medical Instrument JSC

This 2001-established company repairs and distributes high-end imaging equipment and other such diagnostic devices. The company is a representative of Japan’s Hitachi Group, which specializes in medical imaging technology like emergency resuscitation, endoscopy, and simulation equipment, among others. They also provide mobile medical vehicles, wastewater treatment systems, and garbage disposal solutions. In its 20 years of service in Vietnam, J&V Medical has provided facilities like X-ray systems, MRIs, ultrasound systems, computed tomography systems, etc.

Medical Devices Registration in Vietnam: A Case for Contact Lens Manufacturers

Here is a case study showcasing how InCorp Vietnam helped sort out medical device compliance issues of a contact lens manufacturer. EOS Lens is a South Korea-based medical equipment manufacturer that exports soft contact lenses to more than 40 countries across the world. In 2016, the company wanted to enter the Indonesian market, but they needed authorization from the Indonesian Health Ministry as their product fell under the medical device category. 

InCorp Vietnam assisted the company to get the required licenses to import and distribute their products in Indonesia. The InCorp Vietnam team not only provided guidance on local regulations but also helped the company choose a business model and partner with a third-party product license holder for product registration. In this case, InCorp Vietnam acted as the license holder as EOS did not have a local partner in the country.

Download the full PDF guide for the Medical Devices Registration in Vietnam now!

How can InCorp Vietnam Assist?

InCorp Vietnam can handle all the medical device compliance issues in Vietnam. Our team of experienced legal experts is well versed with the changing regulatory landscape of the country. We can help you network and make connections with industry stalwarts in the field and also guide you in choosing the right distributor for your business.

The regulatory experts in our team provide detailed guidance on the following aspects of the medical device market:

• Product assessment
• Regulatory background
• Device classification
• Distributor selection
• Device registration requirements

Get in touch with us for additional details and a fee quotation on registering medical equipment in Vietnam.