A medical device import license is not required for every shipment. Under current regulations, medical devices that already have a market authorization number in Vietnam may be imported based on demand, without quantity restrictions and without requiring approval from the Ministry of Health. Import licenses primarily apply to certain cases involving devices that do not yet have a market authorization number but are brought into Vietnam for specific purposes such as research, training, verification, aid, exhibitions, humanitarian medical examination and treatment, special diagnostic needs, or projects using certain sources of development assistance funding.
Businesses should therefore determine the device's market authorization status and the purpose of importation before preparing an application. Choosing the wrong procedure may result in missing documents, requests for additional information, or an application that is unsuitable from the outset. An import license should also not be treated as a substitute for the applicable standards declaration or market authorization registration procedures required for devices imported for ordinary commercial distribution.
Quick Summary
- Devices that already have a market authorization number in Vietnam do not require Ministry of Health approval for importation.
- Devices without a market authorization number require an import license only when they fall within specific regulated circumstances.
- The standard application package includes an application letter, a Vietnamese technical summary of the device, and a quality management system certificate for the manufacturing facility.
- Each import purpose requires additional supporting documentation.
- Device name, model, manufacturer, quantity, and intended purpose must be consistent across all documents.
- Businesses should verify the device's market authorization status before signing contracts and shipping goods to Vietnam.
First, Answer Two Questions
A business preparing to import medical devices should begin by answering two questions rather than immediately looking for an import license application form.
Does the Device Already Have a Market Authorization Number in Vietnam?
If the device already has a market authorization number, it may be imported based on demand without Ministry of Health approval. The importer must either be the market authorization holder or be authorized by the market authorization holder and must also meet the storage and transportation requirements applicable to the device. Import and export procedures are carried out in accordance with customs regulations.
Before concluding that the device has a valid market authorization number, businesses should cross-check:
- Device name.
- Commercial name.
- Model or list of models.
- Manufacturer and manufacturing facility.
- Market authorization holder.
- Device classification.
- Scope of use.
- Validity status of the regulatory record.
- Any updated or amended documents.
Finding a product with the same name but a different model is not sufficient to confirm that the shipment is covered by the same market authorization.
What Is the Device Being Imported For?
If the device does not yet have a market authorization number, the intended purpose determines whether the business falls within a category eligible to apply for an import license.
The purpose should be described specifically, for example:
- For an approved research project.
- For a technical training program.
- To be sent to a verification or quality assessment organization.
- For display at a specific exhibition.
- As part of an aid program.
- To meet a special diagnostic need at a healthcare facility.
- For use by an individual patient based on an appropriate medical indication.
- For a project funded by a source covered by the applicable regulations.
General descriptions such as "imported for trial use," "for business purposes," or "for customer introduction" may not sufficiently demonstrate the basis for an import license application.
Cases Requiring a Medical Device Import License
Article 48 of Consolidated Document No. 08/VBHN-BYT of 2026 identifies circumstances in which medical devices without a market authorization number require an import license before being brought into use in Vietnam.
| Case | Purpose of Importation |
|---|---|
| Research and assessment | Scientific research, verification, testing, evaluation, or quality assessment |
| Technical training | Training on device use or repair |
| Urgent needs | Disease prevention and control or response to natural disasters and other emergencies |
| Aid and gifts | Aid, humanitarian aid, gifts, or donations to healthcare facilities |
| Trade fairs and exhibitions | Product display or introduction at trade fairs or exhibitions |
| Humanitarian healthcare | Humanitarian medical examination and treatment programs |
| Individual treatment | Individual-use medical devices or devices required for an individual's treatment |
| Special diagnostic needs | Special diagnostic requirements of healthcare facilities |
| Certain externally funded projects | Devices used by healthcare facilities and procured through ODA, concessional loans, or non-repayable aid within the applicable scope |
This list shows that import licenses are intended for specific purposes with a defined basis. They are not a general procedure for importing devices without market authorization for commercial sale.
Scientific Research
Imported equipment should be associated with a defined research project or research activity. Businesses should clarify:
- Project title.
- Lead organization.
- Approval decision.
- Research objectives.
- Number of devices.
- Implementation period.
- Place of use.
- Management plan after completion of the research.
If a device is imported only to collect commercial feedback or demonstrate it to potential customers without an appropriate research project, businesses should not classify the purpose as "scientific research" when preparing the application.
Training
The training activity should have a clearly defined program specifying:
- Training content.
- Participants.
- Venue.
- Timing.
- Organizing entity.
- Equipment to be used.
- Quantity to be imported.
- Management arrangements after the program.
Technical staff training may include operating or repair instructions, but the intended purpose should be consistent with the documentation and plan submitted.
Verification, Testing, or Quality Assessment
The device should be sent to an organization with appropriate authority or capability to perform the required activity. The application should clearly identify the receiving organization and the number of devices.
Businesses should coordinate in advance with the organization performing the work regarding:
- Device name and model.
- Parameters or characteristics to be assessed.
- Number of samples.
- Acceptance conditions.
- Expected timeframe.
- Supporting technical documentation.
- Handling of the device after completion.
Exhibitions or Product Demonstrations
Medical devices without a market authorization number that are imported for trade fairs, exhibitions, displays, or product demonstrations fall within the category requiring an import license. The application should be linked to a specific event and supported by event documentation, an invitation, or a relevant contract.
Businesses should distinguish between:
- Displaying the device at an event.
- Using the device for medical examination, diagnosis, or treatment.
- Selling or transferring the device after the event.
- Lending the device to customers for use outside the exhibition.
If the device is used for a purpose different from the one approved in the import license, the business may need to follow the procedure applicable to the actual intended use.
When Is an Import License Not Required?
Devices That Already Have a Market Authorization Number
Medical devices with a market authorization number in Vietnam may be imported based on demand, without quantity restrictions and without Ministry of Health approval. However, businesses must still comply with requirements relating to the importer, authorization, storage, transportation, and customs procedures.
Not requiring an import license does not mean that no documentation is required. Businesses should still prepare and retain:
- Market authorization number.
- Authorization letter.
- Product identification documentation.
- Catalog.
- Product label.
- Commercial invoice.
- Bill of lading.
- Packing list.
- Origin documentation where applicable.
- Documentation relating to the applicable goods or customs classification code.
- Storage and transportation documentation.
The exact document set should be determined based on customs regulations, the type of goods, contractual arrangements, and shipment-specific requirements.
Devices Without a Market Authorization Number That Do Not Fall Under Article 48
In this situation, businesses should not assume that obtaining an import license is sufficient. If the objective is ordinary commercial distribution, the appropriate market authorization procedure should be considered before importation.
Devices Entering Vietnam Under Other Arrangements
Devices that neither have a market authorization number nor fall within the categories requiring an import license under Article 48 are subject to foreign trade management regulations when brought into Vietnam under other arrangements. Used medical devices are also managed under foreign trade legislation and should not simply be handled under the procedures applicable to new devices.
Standard Application Documents
A medical device import license application includes a core set of documents plus additional supporting documentation depending on the purpose of importation.
Under Consolidated Document No. 08/VBHN-BYT, the general document set includes:
1. An application for an import license.
2. A Vietnamese technical summary of the device.
3. A certificate confirming that the manufacturing facility meets an applicable quality management standard, certified by the organization or individual applying for the license.
Import License Application
Information in the application should be consistent with the other documents, particularly:
- Applicant organization.
- Device name.
- Model.
- Device category.
- Manufacturer.
- Manufacturing facility.
- Country of manufacture.
- Quantity.
- Purpose of importation.
- Receiving organization.
- Place of use.
- Expected timeframe.
A common error is a model number in the application that differs from the model shown in the catalog or quality certificate.
Vietnamese Technical Summary
The document should allow the reviewing authority to understand:
- What the device is.
- Intended use.
- Operating principle.
- Configuration.
- Accessories.
- Key technical specifications.
- Operating conditions.
- Warnings and limitations.
- Intended users.
- Storage requirements.
- Manufacturer information.
Businesses should not simply translate a short advertising page or promotional catalog. The document should accurately describe the specific device and model included in the application.
Quality Management System Certificate
Businesses should verify:
- Manufacturer name.
- Facility address.
- Certification scope.
- Issue date.
- Expiration date.
- Certification body.
- Consistency with other submitted documentation.
If a manufacturer operates several facilities, a certificate issued for a different location may not necessarily cover the manufacturing site listed for the device in the application.
Additional Documentation by Import Purpose
Many applications are delayed not because the standard documents are missing, but because evidence supporting the stated import purpose is incomplete or inconsistent.
Importation for Research
Additional documentation includes:
- A certified copy of the decision approving the research project.
- Documentation showing that the device proposed for import has been authorized for circulation by the competent authority.
- Confirmation from the organization or individual applying for the license on the relevant documents as required.
The device name in the research project, technical documentation, and application should be cross-referencable.
Importation for Training
Additional documentation includes:
- The original training program.
- Documentation showing that the device has been authorized for circulation by the competent authority.
- Confirmation from the organization or individual applying for the license.
The training program should clearly specify its objectives, timing, venue, and how the device will be used.
Importation for Verification, Testing, or Quality Assessment
A confirmation letter is required from the organization authorized or qualified to conduct the verification, testing, evaluation, or quality assessment. The document must specify the number of devices involved.
Importation as Aid
Additional documentation includes:
- A decision from the competent authority approving receipt of the aid.
- Documentation showing that the device has been authorized for circulation.
- Confirmation from the organization or individual applying for the license.
The aid acceptance decision should be consistent with the actual quantity, type of device, and receiving organization.
Importation as Gifts or Donations to Healthcare Facilities
Required documentation includes:
- Documents describing the gift or donation.
- Documentation showing that the device has been authorized for circulation by the competent authority.
- Appropriate confirmation from the applicant.
Describing a shipment as a gift does not remove the need to demonstrate its origin, quality, and intended use.
Importation for Humanitarian Medical Examination and Treatment
The application should include documentation showing that the device proposed for import has been authorized for circulation by the competent authority.
The business and the organization running the humanitarian program should agree on the device list, place of use, timing, and responsible personnel.
Importation for Special Diagnostic Needs
Documentation is required to show that the device has been authorized for circulation by the competent authority, together with records demonstrating the healthcare facility's special diagnostic need.
The need should originate from the healthcare facility and be described with sufficient specificity rather than through a generic request.
Importation for Individual Treatment
For an individual-specific medical device or a device required for treatment of a particular individual, the application should include a copy of an appropriate physician's prescription or indication corresponding to the condition of the person requesting importation.
Personal and medical information should be handled in accordance with applicable confidentiality requirements.
Importation for Trade Fairs or Exhibitions
Additional copies are required of:
- Event documentation.
- Invitation letter.
- Implementation contract.
The event name, dates, organizer, and displayed device should be consistent across the documentation.
Importation for Urgent Needs
The application should include:
- Approval from the competent authority confirming the urgent need.
- Documentation showing that the device has been authorized for circulation or emergency use.
- Confirmation from the organization or individual applying for the license.
Because this procedure is intended for exceptional situations, businesses should not independently classify a commercial need as "urgent" without a basis from the competent authority.
Importation for Certain Projects Using Development Assistance Funding
The application may require:
- Decision approving the investment policy and investment decision.
- Decision approving the project document.
- Equipment supply contract.
- Authorization from the device owner.
- Certificate confirming eligibility to provide warranty services.
- Valid market authorization documentation.
- Translation and certification where documents are not in English or Vietnamese.
Because this category may involve extensive project documentation, businesses should review both medical device management requirements and the corresponding investment, aid, or financing documentation.
Submission Process and Processing Time
Applications for medical device import licenses are submitted through the online public service system for medical device management. From April 1, 2026, Cục Hạ tầng và Thiết bị y tế (the Ministry of Health unit responsible for infrastructure and medical equipment) moved to the new domain vimda.moh.gov.vn; the former domain was announced to continue operating in parallel until September 30, 2026.
The basic process may be prepared as follows:
1. Determine market authorization status.
2. Identify the correct import license category.
3. Collect the standard documents.
4. Collect evidence supporting the intended purpose.
5. Check consistency across all documents.
6. Digitize and name the files.
7. Submit the application online.
8. Monitor processing notifications.
9. Provide additional information as requested.
10. Retain the license and complete application file for customs clearance and future traceability.
Processing Time for a Complete Application
If the application is complete and does not require amendment, the Ministry of Health conducts its review and issues the import license within 15 working days. For devices without a market authorization number that are imported to meet urgent needs for disease prevention and control or disaster response, the processing period is two working days. If a license is not issued, the processing authority must provide a response stating the reasons.
When Additional Documents Are Required
If the application is incomplete, the Ministry of Health will notify the applicant of the required additions or amendments within 10 working days. For urgent applications, the corresponding period is two working days from receipt of a complete and valid application.
If the organization or individual does not submit the required additions or amendments within 30 days from the date of the request, the procedure must be restarted from the beginning.
Businesses should therefore assign a dedicated person to monitor the application regularly to avoid missing notices or submitting additional documentation close to the deadline.
How to Check Document Consistency
Before submission, businesses may use a cross-checking table:
| Information | Application | Technical Documentation | Quality Certificate | Purpose-Specific Documents | Contract / Supporting Documents |
|---|---|---|---|---|---|
| Device name | Check | Check | Check if applicable | Check | Check |
| Model | Check | Check | Check scope | Check | Check |
| Manufacturer | Check | Check | Check | Check | Check |
| Manufacturing facility | Check | Check | Mandatory cross-check | Check | Check |
| Quantity | Check | According to configuration | Not applicable | Mandatory cross-check | Check |
| Purpose | Mandatory | Consistent with intended function | Not applicable | Mandatory evidence | Consistent |
| Receiving organization | Check | Not applicable | Not applicable | Check | Check |
| Timing | Check | Not applicable | Check validity | Check | Check |
If discrepancies are identified, the business should determine whether they result from:
- Typographical errors.
- Different translations.
- Commercial versus technical naming.
- Address changes.
- Changes to the manufacturing facility.
- A model falling outside the scope of the document.
- Expired documentation.
- Documentation relating to a different product.
Differences should not be explained away without supporting evidence or documentation.
Common Issues That Lead to Requests for Additional Information
Applying for an Import License for Ordinary Commercial Importation
An import license does not replace market authorization procedures. Businesses should identify the correct regulatory basis before choosing the procedure.
Failing to Clearly Define the Purpose of Importation
An application stating "for demonstration and training" but supported only by exhibition documents may not sufficiently demonstrate both purposes.
Inconsistent Models
The model shown in the application, catalog, contract, and foreign market authorization documentation should be cross-referencable.
Quality Certificate Does Not Cover the Correct Manufacturing Facility
Even if the parent company name is the same, a different factory address may still require clarification.
Training or Exhibition Programs Are Too General
Documentation should refer to a specific event rather than only an internal plan without dates or venue details.
Failure to Demonstrate That the Device Has Been Authorized for Circulation
Many categories require documentation showing that the device has been authorized for circulation or emergency use by a competent authority. Advertising materials or catalogs do not replace this evidence.
Quantity Is Inconsistent with the Intended Purpose
A large quantity of devices for a small research, training, or exhibition program may require additional explanation.
Resubmitting the Entire Application Without Addressing the Specific Request
When additional information is requested, businesses should prepare a response table addressing each point and clearly identify which documents have been amended.
Checklist Before Submission
- The device has been confirmed as not having a market authorization number.
- The applicable Article 48 category has been identified.
- The import purpose is described specifically.
- Device name is consistent.
- Model is consistent.
- Manufacturer and manufacturing facility are consistent.
- Quantity is appropriate for the intended purpose.
- The current application form is used.
- A Vietnamese technical summary is available.
- The quality management system certificate is valid.
- The certificate covers the correct manufacturing facility.
- All additional documents required for the specific case are available.
- Foreign documents have been translated and certified where required.
- Electronic files are clear and complete.
- File names are easy to identify.
- A responsible person has been assigned to monitor the application.
- A plan is in place for responding to requests for additional information.
- Goods have not been shipped before the import conditions have been fully assessed.
Frequently Asked Questions
Do All Imported Medical Devices Require an Import License?
No. Devices that already have a market authorization number in Vietnam may be imported based on demand without Ministry of Health approval. Import licenses apply only to specific regulated circumstances.
Can a Device Without a Market Authorization Number Obtain an Import License for Commercial Sale?
The import license under Article 48 is linked to specific purposes such as research, training, aid, exhibitions, or special needs. Businesses should not use this procedure as a substitute for applicable standards declaration or market authorization registration for ordinary commercial distribution.
Does a Sample Device Imported for Customer Demonstration Require an Import License?
If the device does not yet have a market authorization number and is imported for product display or demonstration, it falls within the category requiring an import license.
Does an Import License Replace the Market Authorization Number?
No. The license only permits importation for the approved case and purpose. It does not automatically become a market authorization number for commercial distribution.
If Additional Documents Are Requested, Must the Business Restart the Application?
The business should provide the requested additions or amendments in accordance with the notice. However, if no amendments or additional documents are submitted within 30 days from the Ministry of Health's request, the procedure must be restarted from the beginning.
Should a Business Obtain the Import License Before Signing a Contract?
Certain applications may require a contract or project documentation. However, businesses should assess regulatory requirements before committing to delivery schedules or shipping goods. Contracts should include provisions addressing situations in which the license is not issued or the review timeline changes.
This article is provided for informational purposes only and does not replace legal advice or guidance from competent regulatory authorities. Businesses should review the regulations, forms, and procedures in effect at the time of implementation.
Importing Medical Devices for Display at PHARMEDI & HEALTHCARE VIETNAM 2026: What Should Businesses Prepare?
Bringing a medical device from overseas into Vietnam for exhibition purposes involves more than transportation and booth arrangements. Before the goods are shipped, businesses need to determine the device's market authorization status, import purpose, and corresponding documentation, particularly for new products that do not yet have a market authorization number in Vietnam.
This is particularly relevant to international manufacturers and businesses planning to introduce new technologies at PHARMEDI & HEALTHCARE VIETNAM 2026. The event brings together a wide range of product categories, from medical equipment and instruments, diagnostic imaging, and laboratory equipment to healthcare technologies and new medical solutions, providing a platform for companies to present products and connect with professional healthcare audiences in Vietnam.
For devices brought into Vietnam for display or product demonstration, businesses should review the documentation early to ensure that the planned importation is consistent with the device's regulatory status and actual intended use. Key points to check before arranging shipment include:
- Whether the device already has a market authorization number in Vietnam.
- Whether the exact model being brought to the exhibition is covered by an existing market authorization record.
- Whether a device without a market authorization number falls within the category requiring an import license for a trade fair or exhibition.
- Whether the device name, model, manufacturer, and quantity are consistent across all documents.
- Whether the required technical documentation and manufacturing facility certificates have been prepared.
- Whether the event name, dates, and display purpose are presented consistently across the relevant documentation.
- Whether the intended use of the device at the exhibition is consistent with the declared import purpose.
- Whether the plan for handling the device after the event has been clarified.
- Whether sufficient time has been allocated for licensing, transportation, and customs clearance before the exhibition.
Preparing these steps from the outset can help businesses reduce the risk of devices being shipped before documentation is complete, inconsistencies between documents, or actual use differing from the purpose stated in the application.
For companies planning to showcase medical devices, technologies, or new products at PHARMEDI VIETNAM 2026, early booth registration can also provide more time to coordinate exhibition planning with documentation, logistics, and necessary import procedures. The exhibition will take place from September 22–24, 2026, at SECC in Ho Chi Minh City.
Dates: September 22–24, 2026
Venue: Saigon Exhibition and Convention Center (SECC), Ho Chi Minh City
Exhibitor Registration:https://pharmed.vn/exhibitor/application-formVisitor Registration:https://ers-vn.informa-info.com/pha2026?cid=FB
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