Understand Medical Equipment Registration in Vietnam

How to register medical equipment in Vietnam? Read our guide to registration, requirements, process, distributors and potential customers.

From $16.1 billion in 2017 to $20 billion in 2021, healthcare spending in Vietnam increased steadily. It is expected to reach $23.3 billion in 2025 and $33.8 billion in 2030.

Two significant issues facing Vietnam’s medical device and healthcare sectors are the absence of substitute medical tools and outmoded surgical equipment. However, the health problems of the Vietnamese people have led to a US$ 2 billion increase in global medical spending. These factors, backed by Vietnam’s rapid economic growth in recent decades make it an obvious place for investment in the medical industry incluidng importation of new equipment.

Read about Cekindo’s Medical Equipment Registration in Vietnam

Everything you need to know about registering medical devices in Vietnam will be covered in this article, along with the rules you must follow  and the circumstances in which a local distributor or partner might be necessary.

Why You Should Invest in Medical Industry in Vietnam

Over the past few years, Vietnam has achieved notable progress in reducing health related issues affecting society, including malnutrition. However, the nation is also battling infectious diseases like cholera, HIV/AIDS, Avian flu, and measles.

In light of the recent rise in the elderly population, the Vietnamese government is also concentrating on non-infectious conditions such as diabetes, cancer, mental illnesses, and cardiovascular diseases.

As a result, the authorities want to enhance funding for the medical and healthcare sectors, particularly for equipment and supplies. By modernizing its healthcare system, boosting government investment, and expanding insurance coverage, Vietnam has made great strides over the years to ensure that all its inhabitants have access to high-quality healthcare services.

There needs to be more medical equipment and supplies in Vietnam. It is urgently necessary for many hospitals and medical facilities to upgrade their current tools and equipment. The current deficits present potential for foreign investment in infrastructure facility development and administration, medical technology, and vocational training.

Local Vietnamese businesses, however, need more know-how and resources to develop cutting-edge medical products. As a result, Vietnam still significantly depends on foreign manufacturers or imports.

About 90% of the medical equipment used in Vietnam is predominantly imported from different nations, including the US, China, and Japan. Consumables, diagnostic imaging tools, orthopedic devices, dental items, and prosthetics are all included in these medical supplies.

Given a significant profit margin of between 20-30% for the sale and registration of medical devices, the Vietnamese market for medical devices has developed into a highly profitable venturefor investors.

RELATED: Frequently Asked Questions about Medical Equipment Registration in Vietnam

Registering Medical Equipment in Vietnam

One of Southeast Asia’s markets with the fastest growth is the medical device market in Vietnam. The Ministry of Health’s Department of Medical Equipment and Health Works (DMEHW) oversees the regulation of devices (MOH).

If you plan to distribute or sell medical equipment in Vietnam, you should register your medical items by acquiring a license before they can reach the market.

Medical Device Classification

The word “medical device” refers to a broad range of tools used to treat, diagnose, prevent, or mitigate a disease or abnormal physical state.

Medical devices are categorized based on risk to meet the standards of the Global Harmonization Task Force (GHTF) and the ASEAN Medical Device Directive (AMBDD).

Class ALow RiskCotton, surgical gloves, hospital beds
Class BLow Moderate RiskBreathing mask, pregnancy test kits, electronic forehead thermometer
Class CModerate High RiskCondoms, electric scalpel accessories, implants
Class DHigh RiskAntibacterial gauze, surgical kits, artificial bones
Medical Device Classification

The Process and Licensing

The process

Before you wish to access the market, there are two essential steps in the licensing process:

  • Step 1: Similar to most other markets, Vietnam’s regulatory standards and practices for a medical device’s distributor and seller are based on the device’s classification. As a result, the initial accountability for the type of medical device is entrusted to the entity registering or declaring the medical device.
  • Step 2: Following are the registration procedures according to the decided class

Read about Cekindo’s Medical Equipment Registration in Vietnam

  • Registration procedure for Class A/B medical devices

All Class A and B products must undergo a registration procedure known as a “Declaration of Applied Standard,” submitted to the Department of Health in the province where the business is headquartered. The marketing authorization code (MAC) in your Declaration of Applied Standard also permits the sale of your products in Vietnam.

  • Registration procedure for Class C/D medical devices

All Class A and B products must undergo a registration procedure called a “Declaration of Applied Standard,” submitted to the Department of Health in the province where the business is headquartered. The marketing authorization code (MAC) in your Declaration of Applied Standard also permits the sale of your products in Vietnam.

There is no expiration date on the MAC for any device.

The license

Several legal and technical documents are needed to register medical devices in Vietnam. Free sale certificates, letters of authorization, and ISO13485 certificates are legal documents. Technical materials comprise the categorization outcome, technical summary, Vietnamese usage instructions, labeling, and catalog. Additionally, the outline of clinical trial results is required for medical devices in classes C and D that outcompete the human body.

Import and Distribution Requirements

Import Requirements

The Vietnamese government has implemented updates regarding the management  of domestically produced and imported medical equipment under Decree No. 36/2016/NP-CP. Therefore, the local offices of overseas medical device manufacturers and distributors should handle the application for MA licenses. However, if foreign firms still require representative offices in Vietnam, they can choose a distributor or a partner firm to act as the MA Holder.

Distribution Practice

According to Vietnamese law, only Vietnamese companies with Vietnamese registration and import authorization can lawfully distribute medical devices in Vietnam.

Therefore, foreign medical device vendors must appoint local offices or distributors. Foreign medical equipment manufacturers frequently distribute their products through regional distributors like InCorp Vietnam.

These Vietnamese distributors can establish an immediate connection with Vietnamese clients. Additionally, they know Vietnam’s most recent laws governing medical equipment.

Medical Device Purchasers

There are four primary categories of people who buy medical devices:

Government-funded hospitals, health centers, and clinics.

With 70% of the market for medical equipment, public hospitals tend to buy the most medical equipment. Foreign providers can also sell to the public sector, however they must collaborate with a local partner to sell medical equipment to these hospitals. Additionally, more sophisticated and recognizable equipment is usually chosen because of the government’s financial backing.

Local private hospitals

Private hospitals are anticipated to increase most rapidly within private healthcare. Therefore, these institutions search for updated facilities and equipment to compete with government-owned and foreign-owned healthcare institutions.

RELATED: Frequently Asked Questions about Medical Equipment Registration in Vietnam

Foreign-owned or Joint-venture hospitals and clinics

These tend to be large private hospitals with foreign backing and  frequently buy high-tech equipment from the nation that sponsors them. Therefore, they tend to have larger budgets in order to have the latest in medical tech. 

Medical education and research institutions

These institutions are willing to experiment with cutting-edge medical goods, which helps to explain some of the demand for new medical equipment. Additionally, this group allows foreign businesses to test the market for their latest items.

Ready to Register Your Medical Equipment?

Let InCorp Vietnam assist you in analyzing the medical device regulatory framework used in Vietnam. Utilizing the expertise of our experts as well as our extensive global network of industry and regulatory connections, InCorp Vietnam can provide accurate and valuable analysis of the medical device market in Vietnam. We can also assist with introducing your products to established distributors in the country in order to ease the process. 

Our regulatory strategy service regarding the Vietnamese medical device market provides the following information.

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

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

About Us

InCorp Vietnam is a leading provider of global market entry services. We are part of InCorp group, a regional leader in corporate solutions, that encompasses 8 countries in Asia-Pacific, headquartered in Singapore. With over 1,100 legal experts serving over 15,000 Corporate Clients across the region, our expertise speaks for itself. We provide transparent legal consulting, setup, and advice based on local requirements to make your business perfectly fit into the market with healthy growth.

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Verified by:​

Thanh (Tim) Ta

Tim Ta is the Head of the Business Consulting Department of Incorp Vietnam. He is a seasoned professional with more than 6 years of consulting experience in Vietnam for market entry, incorporation, and real estate investment.

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