What Challenges Do Foreign Medical Device Manufacturers Face When Selling Products in Vietnam?
Vietnam is one of the fastest-growing medical device markets in Southeast Asia. The increasing demand from hospitals, clinics, and distribution companies has created significant opportunities for international manufacturers.
However, many companies - medical equipment manufacturing/trading unit still encounter difficulties in accessing this market.
A common situation is as follows:
A medical device manufacturer identifies a potential customer in Vietnam who wishes to import its products. However, the customer does not yet have an Import License for those products.
As a result, the manufacturer often has to:
- Prepare a complete set of regulatory documents for each individual customer in Vietnam (ISO 13485, CFS, list CSDT...);
- Assist with consular legalization, signing confirmations, providing explanations, and submitting supplementary documents multiple times;
- Wait for the customer to complete the licensing process, which may take several months or even years before the products can finally be imported;
- Face the risk that the customer may change its purchasing plan or switch to a competitor's products due to the lengthy waiting period.
This not only causes your company to miss business opportunities and slow down market expansion, but also generates considerable labor costs associated with supporting regulatory dossiers for each customer separately.
Why Do Major Medical Equipment Business unit Prefer to Own Their Marketing Authorization in Vietnam?
To proactively develop the Vietnamese market, many international manufacturers choose to secure their Marketing Authorization in Vietnam from the outset.
However, under current regulations, holding a Marketing Authorization generally requires the manufacturer to establish a legal entity or appoint a legally authorized representative in Vietnam.
Establishing a company in Vietnam may involve:
- Company incorporation and annual maintenance costs;
- Expenses related to office rental, employees, accounting, and administration;
- Tax obligations and compliance with Vietnamese corporate regulations;
- Maintaining a dedicated team to manage regulatory dossiers.
For many manufacturers, this represents a significant investment before the market has begun generating substantial revenue.
✅The Solution: Airseaglobal as Your Local Registration Holder in Vietnam
Airseaglobal provides Local Registration Holder (MAH) services for foreign medical device manufacturers.
Through this model, manufacturers can establish a long-term presence in Vietnam without setting up their own local company.
How Does the Service Work?
Step 1: Obtain an Medical Device Registration
Airseaglobal works closely with Your Business to prepare dossiers and complete procedures for obtaining an Import License for medical devices in Vietnam.
Step 2: Airseaglobal Maintains the Medical Device Registration
Airseaglobal acts as the local representative responsible for maintaining the regulatory dossier in Vietnam, including renewals, amendments, and communications with the competent authorities whenever necessary.
Step 3: Expand Your Customer Network in Vietnam
When a new customer in Vietnam wishes to import your products:
❌ The manufacturer does not need to prepare a new regulatory dossier.
❌ There is no need to wait several months for the customer to apply for an Import License independently.
✅The manufacturer simply signs an "Import License Authorization Letter", allowing the customer to import the products immediately.
✅ Customers can commence imports much faster, enabling manufacturers to close deals sooner and recognize revenue earlier.
✅More importantly, this creates a substantial competitive advantage compared to situations where customers must spend additional costs and wait months or years to obtain their own Import License.
Benefits for Foreign Medical Device Business
Maintain Full Control Over the Vietnamese Market
Manufacturers are not tied to a single distributor.
They can cooperate with multiple partners based on their own business strategy.
Accelerate Sales Growth
New customers in Vietnam do not have to start from scratch with regulatory procedures.
The time required to move from initial customer contact to product delivery can be significantly reduced.
Reduce Costs
There is no need to establish a company in Vietnam.
Medical equipment business unit do not need to maintain an in-house regulatory or legal team locally.
Strengthen Competitive Advantage
When Vietnamese customers inquire about your products, you can confidently say:
"Our products have already been registered in Vietnam, and we can support your importation within a short period."
Instead of saying:
"Please wait while we prepare the dossier and complete the registration process, which may take several months."
Contact: +84397.953.803 (Zalo/Tel/wechat/whatsapp – Ms. Huong)
Mail: Huongntt@airseaglobalgroup.com.vn
