In 2017 alone, medical equipment and healthcare expenses contributed by 7.5% to the GDP. It is also forecast that this sector will grow at a compound annual growth rate (CAGR) of 12.5% between 2017 and 2021.
One of the major challenges in medical devices and healthcare sector in Vietnam is the obsolete equipment for surgery and the shortage of other medical tools. These problems have caused the Vietnamese people to seek medical treatment abroad, with overseas spending rising to US$ 2 billion.
In this article, we will provide all you need to know about medical devices registration in Vietnam, what regulation you must comply with and under what circumstances a local distributor or partner is needed.
Why You Should Invest in Medical Industry in Vietnam
Vietnam has made significant improvements in decreasing certain conditions such as malnutrition over the past few years. In addition, the country is now fighting against infectious diseases such as cholera, HIV/AIDS, Avian flu and measles.
With the booming of the elderly population in recent years, the government of Vietnam is also targeting non-infectious diseases including diabetes, cancer, mental disorders and cardiovascular diseases.
As a result, the Vietnamese government aims to increase investments in the healthcare and medical industry, especially on medical devices and supplies.
Medical devices and supplies in Vietnam have been in a shortage condition. Many hospitals and medical institutions are in urgent need to upgrade their existing equipment and instruments.
However, local companies in Vietnam lack the technology and knowledge to produce advanced medical devices. Thus, the country now relies heavily on foreign investors as importers or manufacturers.
In Vietnam, about 90% of the medical equipment are imported from various countries such as the US, China and Japan. These medical supplies include consumables, diagnostic imaging equipment, orthopedic instruments, dental products and prosthetic devices.
Overall, the sector of medical devices has become a lucrative business for many investors in Vietnam as there is a whopping profit margin of between 30-40% for medical devices distribution and registration.
Registering Medical Equipment in Vietnam
Vietnam’s medical device market is one of the most rapidly growing markets in Southeast Asia. Devices are regulated by the Department of Medical Equipment and Health Works (DMEHW) under the Ministry of Health (MOH).
If you are planning on distributing or selling medical equipment in Vietnam, you will most likely need to register your medical products by securing a license, before any medical devices enter the market.
The Process and Licensing
Starting from 2017, both local and imported medical devices must acquire a Marketing Authorization (MA) license and other required documents including Good Manufacturing Practice (GMP) or Certificate of Pharmaceutical Products (CPP).
As in most other markets, a medical device distributor’s and seller’s regulatory requirements and process in Vietnam depend on its device’s classification.
The MOH started receiving an application for Class A medical device registration documents from January 1st, 2017. As for Class B, C and D medical device, the authority started receiving registration documents from July 1st, 2017.
Medical Device Classification
The term “medical device”, covers a wide range of medical or health instruments used in the treatment, diagnosis, prevention or mitigation of a disease or abnormal physical conditions.
Medical devices are classified according to a risk-based system, mainly to reconcile with the ASEAN Medical Device Directive (AMDD) and The Global Harmonization Task Force (GHTF) recommendations.
Medical items categorized as Class A require a standard dossier declaration, while Class B, C and D medical instruments need a free sale registration dossier (CFS):
- Class A – Medical devices of “the lowest risk”
- Class B – Medical devices of “low risk”
- Class C – Medical devices of “high risk”
- Class D – Medical devices of “the highest risk”
Class A medical devices and supplies are considered “ the lowest risk”, and they include cotton, surgical gloves, hospital beds and bandages. For Class B, Class C and Class D, the medical devices and supplies are considered from “low-risk” to “the highest risk”.
As the description implies, high-risk medical devices are often more invasive, for examples, pregnancy test kits, implants or contact lenses.
MA licenses are valid indefinitely for Class A medical devices. For Class B, Class C and Class D medical devices, the validity of MA licenses is 5 years.
In addition, Class C and D medical devices are applied to the human body, and thus they also require a Summary of Clinically Testing Data, along with the clinically testing research results.
Other than that, Class C and Class D medical devices for in vitro diagnosis require a Certificate of Inspection.
Import and Distribution Requirements
The medical device import in Vietnam grows around 10% each year. The major countries exporting medical devices to Vietnam are Germany, Japan, the USA, Korea, and China.
Based on Decree No. 36/2016/NP-CP, the government of Vietnam has brought both local and imported medical devices under uniform management. For foreign medical device providers and distributors, their local offices should be responsible for MA licenses application. If foreign companies do not have representative offices in Vietnam, it is possible for them to appoint a distributor or a partner company to be the MA Holder.
Under the Law of Vietnam, only businesses registered in Vietnam with an import license will be able to distribute medical devices legally in Vietnam.
Therefore, foreign medical device suppliers are required to set up a local office or appoint local distributors. Most often, foreign medical device suppliers opt for selling their medical devices through local distributors such as Cekindo.
This is because these distributors in Vietnam are able to provide an immediate connection to the Vietnamese customers. They are also familiar with the most updated regulations in regards to medical equipment in Vietnam.
Medical Device Purchasers
There are 4 main groups of medical device purchasers:
Government-funded hospitals, health centers and clinics
This category purchases the largest quantity of medical devices — accounting for 70% of the medical device market. However, foreign suppliers must work with a domestic partner in order to sell medical equipment to these hospitals. Also, due to the financial support from the government, more advanced and branded devices are chosen.
Local private hospitals
They are expected to experience the strongest growth in private healthcare. Therefore, these institutions are looking for facilities and equipment upgrade in order to keep up with the public and foreign-owned healthcare institutions.
Foreign-owned or joint-venture hospitals and clinics
They tend to purchase devices with advanced technology from their sponsoring country.
Medical education and research institutions
These institutions are open to experiments with new and innovative products, accounting for some demand for new medical devices. This group also offers an opportunity for foreign companies to test the market for their new products.
Ready to Register Your Medical Equipment?
Let Cekindo help you evaluate your medical device regulatory framework applied to medical devices in Vietnam. Cekindo can leverage the expertise of our consultants as well as our global network of industry and regulatory contacts to provide accurate and actionable analysis of the medical device market in Vietnam.
Our regulatory strategy service provides the following information about the Vietnamese medical device market.
- Regulatory background
- Product assessment
- Device classification
- Medical device registration requirements
- Distributor selection
Contact us for more information and a free quotation on medical equipment registration in Vietnam.