- What are Medical Devices?
- Medical Device Classification
- Medical Industry in Vietnam
- Registering Medical Equipment in Vietnam
- Import and Distribution Requirements
- Comparison between Two Trends of Clients
- Medical Device Purchasers
- Common Risks for Medical Devices Investors
- Ready to Register Your Medical Devices?
From US$16.1 billion in 2017 to US$20 billion in 2021, healthcare spending in Vietnam increased steadily. Therefore, it is expected to reach US$23.3 billion in 2025 and US$33.8 billion in 2030.
Two significant issues facing medical devices in Vietnam 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 including the importation of new equipment.
In fact, this article will offer comprehensive insights into the medical device registration process in Vietnam, covering essential regulations and situations where obtaining InCorp Vietnam’s Medical Devices License Holder status is imperative.
What are Medical Devices?
According to Caluse 1, Article 2 of the Circular 30/2015/TT-BYT, medical equipment comprises various tools, materials, in-vitro diagnostic chemicals, and software that are used either separately or in combination, as specified by the owner, to serve diverse purposes, including:
- Diagnosing, preventing, monitoring, treating, and mitigating diseases or compensating for injuries;
- Checking, replacing, modifying, or providing support for surgical and physiological processes;
- Supporting and sustaining life;
- Conception control;
- Sterilizing medical equipment (excluding household and medical use chemicals and insecticides);
- Utilizing medical equipment;
- Providing specialized transport for medical activities.
The word “medical device” refers to a broad range of tools used to treat, diagnose, prevent, or mitigate a disease or abnormal physical state. So, it means that medical devices is different from medicine (drug).
Medical Device Classification
- Based on the Global Harmonization Task Force (GHTF) and the ASEAN Medical Device Directive (AMBDD)
|Class A||Low Risk||Cotton, surgical gloves, hospital beds, etc.|
|Class B||Low Moderate Risk||Breathing masks, pregnancy test kits, electronic forehead thermometer, etc.|
|Class C||Moderate-High Risk||Condoms, electric scalpel accessories, implants, etc.|
|Class D||High Risk||Antibacterial gauze, surgical kits, artificial bones, etc.|
- Based on the Food and Drug Administration (FDA)
|Class I||Common, Low Risk, Low Complexity||Elastic Bandages, Examination Gloves, Dental Floss, Hand-held Surgical Instruments, etc.|
|Class II||More Complex, Greater Risk to Patient, Partially Implanted||Computed Tomography Scanners, Syringe, Infusion Pump, Powered Wheelchairs, etc.|
|Class III||Fully Implanted, Greater Risk, Regulate Body Functions||Breast Implants, Pacemakers, Defibrillators, Fetal blood sampling monitors, etc.|
Besides, foreign investors can refer to medical devices in Vietnam through the Annex 1 of Circular 30/2015/TT-BYT.
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.
By modernizing its healthcare system, increasing government investment, and expanding insurance coverage, Vietnam has significantly improved access to high-quality healthcare services for all its citizens.
Moreover, there is a pressing need for additional medical equipment and supplies within Vietnam. Many hospitals and healthcare facilities urgently require upgrades to their current tools and equipment. These existing shortfalls offer promising opportunities for foreign investment in infrastructure development and management, medical technology, as well as 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.
Roughly 90% of medical equipment utilized in Vietnam is predominantly sourced from various countries, notably the US, China, and Japan. This extensive range of imported medical supplies includes consumables, diagnostic imaging tools, orthopedic devices, dental items, and prosthetics.
Furthermore, given the substantial profit margin, which typically falls within the range of 20-30%, associated with the sale and registration of medical devices, the Vietnamese medical device market has transformed into an exceedingly attractive and financially rewarding prospect for potential investors.
Registering Medical Equipment in Vietnam
The Ministry of Health’s Department of Medical Equipment and Health Works (DMEHW) regulates medical devices in Vietnam. If you want to distribute or sell medical equipment in Vietnam, you must obtain product registration, which does not expire.
- Registration procedure for Class A/B medical devices
All Class A and B products require a registration procedure called “Declaration of Applied Standard,” which should be submitted to the Department of Health in the province where your business is located. Also the marketing authorization code (MAC) in your Declaration of Applied Standard allows you to sell your products in Vietnam within 1 to 3 months.
|Required Document for Class A||Items Required||Note|
|1.||Classification||01 Original Copy||Issued by qualified Lab/ Company in Vietnam.|
|2.||ISO certificate (ISO 13485)||01 Legalized at Viet Embassy|
|3.||Letter of Authorisation||02 Original||InCorp will support client to draft this form if required|
|4.||The certificate of warranty qualification issued by the product owner|
(except for disposable medical devices defined by the product owner or there are documents proving that the device is not under warranty)
|01||InCorp will support client to draft this form if required|
|5.||Brief description of the medical device in Vietnam language|
(The document contains the description of functions and specifications of the medical device).
|01||InCorp will support client to draft this form if required|
|6.||Declaration of Conformity (of the manufactory)||01 Scan copy of Original|
|7.||The instruction manual of the device||01 Scan copy of Original|
|8.||A sample of the label for the devices sold in Vietnam||01 Original in PDF||Good quality file|
|9.||CFS||01 Legalized at Viet Embassy|
|10.||E-signature of the Product-license-holder-company||1 USB|
- Registration procedure for Class C/D medical devices
Comparatively, Class C and D products require a “Declaration of Applied Standard” registration submitted to the local Department of Health where your business is based. The marketing authorization code (MAC) in your declaration allows product sales in Vietnam within 6 to 12 months, with the possibility of an extension up to 18 months.
|Required Document for Class B, C, D||Items Required||Note|
|1.||Classification||01 Original Copy||Issued by a qualified Lab in Vietnam.|
|2.||ISO certificate (ISO 13485)||01 Legalized at Viet Embassy||Has to be in English (if not, has to be translated into Vietnamese)|
|3.||(POA) The Owner of Product authorises Company in Vietnam to be license holder||02 Legalized at Viet Embassy||InCorp will support client to draft this form if required|
|4.||CFS||01 Legalized at Viet Embassy||Has to be in English (if not, has to be translated into Vietnamese)|
|5.||Brief description in Vietnam language||01 Original copy||Has to be in English (if not, has to be translated into Vietnamese) |
InCorp will support client to draft this form if required
|6.||Catalogue||01||Translated into Vietnamese|
|7.||The instruction manual of the device||01||Translated into Vietnamese|
|8.||Label||01 Original||Good quality PDF file|
There is no expiration date on the MAC for any device.
Import and Distribution 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.
In addition, 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. Because they know Vietnam’s most recent laws governing medical equipment.
Comparison between Two Trends of Clients
|Client is License Holder||Clients don’t need to be a License Holder|
|1.||– Right to Import & Distribute|
– Right to Change Distributor
|– Depend on Distributor or Third Party|
|2.||– Have to Establish Company with Two Options: Limited Liability Company or Representative Office||– Reach out with Two Options: Distributor or Third Party (removes dependence on Distributor)|
|3.||– Find Distributor||– Find Distributor (if Clients use Third Party)|
|4.||– Start Importing & Distributing||– Start Importing & Distributing|
|5.||– Same for Local & Foreign Companies|
– Same if Remote/ Online Procedures
|– Same for Local & Foreign Companies|
– Same if Remote/ Online Procedures
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.
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.
Common Risks for Medical Devices Investors
Foreign investors will be required to submit all of the above documents based on each business condition and product classification. This can easily lead to delays due to the long process of preparing documents and it will consume time for foreign businesses. Besides, problems will occur if products and goods registered in the form of ISO in the home country expire. Businesses need to check all product documents for validity to legalize them. It will cost at least another year. Any new regulations can delay business progress.
DMEC (Department of Medical Equipment and Construction) and DAV (Drug Administration Department of Vietnam) stated that Class C medical equipment carries a medium to high level of danger, but Class D equipment (such as implants into human bodies) carries a high level of risk. Before being utilized on a regular basis, Class C and Class D equipment must pass clinical trials (on humans) to determine its safety.
Ready to Register Your Medical Devices?
Let InCorp Vietnam assist you in analyzing the regulatory framework used for medical devices 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.
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