This guide is written for foreign manufacturers, importers, distributors, healthcare providers, research organisations, and businesses preparing to enter Vietnam's medical device market. Getting the distinction wrong doesn't just delay paperwork. It creates real risk around customs clearance, lawful marketing, patient safety, and supply-chain planning.
"Import licence" gets used loosely in practice, and it's often confused with a registration number, a market authorisation, or a customs clearance document. They're not the same thing. Below, we walk through the decision process, required documents, tax considerations, and the rule changes that took effect after 30 June 2025 - along with what to verify before you file or ship in 2026.
Key Takeaways
- A special-purpose import licence doesn't automatically permit commercial marketing or sale in Vietnam.
- Device classification, intended purpose, and registration status decide your regulatory pathway.
- Research, testing, training, aid, exhibitions, and emergencies may qualify under Decree No. 98/2021/ND-CP.
- Devices for commercial sale generally need a declaration or registration number, not an import licence.
- Confirm 2026 Ministry of Health and customs requirements before shipping anything.
What Is a Medical Device Import Licence in Vietnam and When Is It Required?
Vietnam's medical device framework runs on Decree No. 98/2021/ND-CP, administered by the Ministry of Health's Department of Medical Infrastructure and Equipment (commonly shortened to IMDA).
Article 48 of the decree provides an import licence for devices imported for specified purposes - not a blanket authorisation for unrestricted commercial distribution.
Three things get confused constantly:
- Import licence - permits import of an unregistered device for a defined, permitted purpose.
- Declaration or registration number - the actual mechanism for placing a device on the commercial market, depending on its risk class.
- Customs clearance documents - confirm import formalities were completed. They don't replace medical device regulatory approval.
Device Risk Classes Matter
Vietnam classifies devices into four risk tiers:
- Class A - low risk
- Class B - low-to-moderate risk
- Class C - moderate-to-high risk
- Class D - high risk
Where a device could fit more than one classification rule, the higher-risk classification applies.
That choice drives the pathway: Class A and B devices typically move through a declaration of applied standards, while Class C and D devices need a registration certificate - a materially different (and usually longer) process.
When an Import Licence Applies
Article 48 covers specific scenarios, including:
- Scientific research, testing, inspection, or performance evaluation
- Training in device operation or repair
- Humanitarian aid, donations, or gifts to health facilities
- Exhibitions, fairs, and product demonstrations
- Charitable treatment or an individual patient's personal treatment
- Emergency response to epidemics or disasters
- Certain used-device imports (though "used" alone doesn't automatically qualify)
Each scenario has its own eligibility criteria, evidence requirements, and quantity limits. Don't assume one approval type covers a different purpose just because both fall under Article 48.
How the Vietnam Medical Device Import-Licensing Process Works
This is a decision flow, not a single form to fill out.
Step 1: Identify the fundamentals. Confirm the device's classification, intended use, and whether it already holds a valid Vietnamese registration number or declaration.
Step 2: Determine the shipment's real purpose. Is this a commercial shipment for sale, or does it fall under a permitted special-purpose category like research or training?
Step 3: Select the pathway. Commercial devices with a registration number generally import without a separate MOH licence. Unregistered devices for a qualifying special purpose need an Article 48 licence instead.
Step 4: Confirm who's applying. Identify the responsible Vietnamese applicant - this could be the authorised importer, the registration-number holder, or an appointed local representative.
Building the Application
Once you've confirmed the pathway, the application itself generally requires:
- The application form specific to your purpose (research, training, exhibition, etc.)
- A Vietnamese technical summary of the device
- Manufacturer quality documentation, such as the quality-management-system certificate
- Purpose-specific evidence for your scenario (research approval, training outline, event documents, prescription, or emergency authorisation)
Submit through the Ministry of Health's current procedure. The MOH announced its medical device portal is moving from imda.moh.gov.vn to vimda.moh.gov.vn from 1 April 2026.
Confirm you're using the live submission route before lodging anything. Procedures tied to a retired portal address can cause delays.
Expect the authority to request corrections or clarifications. Respond within the prescribed period and retain the final approval for both customs clearance and your internal compliance records.
Timelines and fees: There is no single verified statutory processing period or fee schedule for Article 48 applications that holds in every case. Translation issues, legalisation requirements, and classification questions often extend timelines in practice. Confirm current figures directly with IMDA before you plan around a specific date.
After Approval
Once you receive the licence, match the shipment precisely to the approved device, manufacturer, purpose, and quantity. Complete customs procedures, restrict actual use to the approved purpose only, and keep traceability records on file.
The Commercial-Sale Pathway
If your device is headed for routine commercial sale rather than a special purpose, you generally need a declaration of applied standards or a registration number instead.
You will also need product information, Vietnamese instructions for use, compliant labelling, and warranty arrangements before import or distribution.
Documents, Classification, and Compliance Factors That Affect Approval
Documentation requirements shift depending on your import purpose. Here's a route-aware checklist.
Generally required:
- Import licence application and Vietnamese technical summary
- Manufacturer quality management system documentation (such as ISO 13485 evidence), where applicable to the route
Required for specific routes:
- Certificate of Free Sale or proof the device is legally marketed at origin, where the specific route calls for it
- Letter of authorisation and local applicant details
- Purpose-specific evidence (research approval, training outline, aid documentation, event materials, physician's prescription, emergency authorisation)
- Vietnamese translations, certification, and consular legalisation where required
Why Classification Consistency Matters
Your device's classification and stated purpose need to line up across every document you submit - the application, supporting foreign approvals, technical file, and customs declaration. Mismatches between what your CFS says and what your label says are one of the most common reasons applications stall.
Research the current classification rules and portal-specific requirements before you compile the dossier, since these details do get updated.
Labelling and Local Operations
Vietnamese labelling needs to align with your approved dossier on:
- Product name and model
- Manufacturer and country of origin
- Intended purpose and warnings
- Importer or responsible-entity information
You'll also need:
- An eligible Vietnamese importer or authorised entity
- Proper storage and transport controls
- Inventory tracking that can demonstrate traceability if questioned later
Duties and Taxes
An import licence does not eliminate customs duties or VAT. These are separate decisions entirely. Before shipping, confirm:
- The correct HS code and tariff classification for your specific device
- Ordinary duty rates versus any preferential treatment under a free-trade agreement
- VAT treatment and customs valuation
- Any exemption tied specifically to your import purpose
Vietnam Customs issues product-specific classification rulings, and rates vary by device type and origin. Confirm current figures with Vietnam Customs and a qualified customs adviser before you commit to a shipment - don't assume last year's rate still applies.
Where the Rules Apply After the End of Transitional Derogations
Decree No. 04/2025/ND-CP amended Decree 98's transitional provisions.
Several temporary carry-over permissions ran through 30 June 2025. That included certain import licences originally issued between 2018 and 2021, and a time-limited exception for qualifying Class C/D devices with published classification results.
That sunset date matters, but it's easy to misread. It ended specific transitional permissions. It did not repeal Article 48's ongoing, purpose-specific import-licence mechanism, which still appears in the Ministry of Health's consolidated 2026 text.
What this means practically:
- Don't assume a legacy licence or temporary permission remains valid for new shipments after this date.
- Confirm your device's current registration, licence, or declaration status before importing, even if it shipped fine last year.
- Impact varies by role: manufacturers, Vietnamese importers, local representatives, hospitals, research bodies, and exhibition organisers each face different obligations.
Circular 44/2025/TT-BYT also shifted processing responsibility for Article 48 applications to the Department of Medical Infrastructure and Equipment.
Alongside the portal migration and the 2026 consolidation, authority names, portal status, fees, and submission rules can change quickly. Confirm each of these before you file.
Common Issues, Misconceptions, and Cases Where an Import Licence Is Not Appropriate
Misconception #1: Every imported medical device needs an import licence. Not true. Devices with a valid registration number generally follow the ordinary import and customs route. The Article 48 licence exists specifically for unregistered devices entering under a defined special purpose.
Misconception #2: A special-purpose licence covers resale. A research, exhibition, humanitarian, or personal-treatment licence does not authorise general resale. That use is a purpose mismatch.
Confirm current Ministry of Health enforcement rules and treat misuse as non-compliant. The importer remains legally responsible for the device's type, quantity, and intended use regardless of which licence cleared customs.
Application Failures Worth Avoiding
Common reasons applications get rejected or delayed:
- Incorrect device classification
- Inconsistent product names or codes across documents
- Expired ISO or CFS certificates
- Missing consular legalisation
- Incomplete Vietnamese translations
- Weak or missing purpose-specific evidence
- Quantity mismatches between the application and the actual shipment
- Labels that don't match the approved dossier
When a Different Route Fits Better
Sometimes the right answer isn't an import licence at all. Consider:
- A declaration of applied standards, if your device is an eligible Class A or B product
- A registration number, if you're dealing with Class C or D devices intended for the market
- Confirming scope, if the product might not even qualify as a medical device under Vietnamese law
Get specialist advice when:
- Classification feels uncertain
- The product is software or an in-vitro diagnostic
- The shipment involves used equipment
- Your intended purpose does not cleanly fit a documented exemption
Conclusion
Vietnam's import-licence analysis starts with your device's classification, intended purpose, registration status, and commercial objective, not simply the fact that it was manufactured overseas. Get those four elements right, and the rest of the process becomes far more predictable.
A complete, internally consistent dossier with accurate Vietnamese documentation reduces both customs friction and market-access risk. A special-purpose licence also needs to stay within its approved conditions. Stretching it to cover resale or unrelated distribution creates compliance exposure that is not worth the risk.
Verify current 2026 rules directly with the Ministry of Health, IMDA, and Vietnam Customs before you ship anything.
For Australian businesses managing cross-border setup, tax, and financial-compliance obligations alongside overseas expansion, VJM Global can help coordinate that wider picture. Vietnam-specific regulatory filings should always go through a qualified local adviser.
Frequently Asked Questions
What import duties and taxes apply to medical device imports in Vietnam?
Duty and VAT depend on the device's HS classification, customs value, country of origin, and any applicable trade agreement or exemption. Verify current rates with Vietnam Customs and a qualified tax adviser before shipping.
How do you obtain a medical device import licence in Vietnam?
First confirm your device and purpose qualify under Article 48 of Decree No. 98/2021/ND-CP, then prepare the purpose-specific dossier with Vietnamese documentation. Submit through the current Ministry of Health process, respond promptly to any correction requests, and use the licence strictly for the approved shipment and purpose.
What are the regulations for medical devices in Vietnam?
Decree No. 98/2021/ND-CP is the central framework, covering classification, declarations, registration numbers, import licences, labelling, distribution, and post-market obligations. Always check for later amendments and MOH guidance, since this area updates regularly.
What are the key changes in medical device regulations for 2026?
Verify current amendments directly with the Ministry of Health, since several transitional permissions ended on 30 June 2025. Check the current MOH portal, fees, and any procedural updates before filing.
