What Is the Difference Between a Medical Device Import License and a Registration Certificate in Vietnam?

Direct Answer

In Vietnam, the import license and the registration certificate (commonly referring to the Circulation Registration Number) are two distinct administrative approvals that control different stages of market entry. The registration certificate is the market authorization for a specific medical device, issued by the Medical Device Administration under the Vietnamese Ministry of Health (MOH); it confirms that the product complies with applicable safety and efficacy standards and permits its sale and use within Vietnam. The import license, by contrast, is a document that must be obtained before each consignment is imported; it is applied for on the basis of a valid registration certificate and reviewed by the MOH or customs authorities to control import quantity, specifications and batch.

In short, the registration certificate determines whether a product may be sold, while the import license determines whether a shipment may enter the country. A company must first obtain the registration certificate and can only then apply for import licenses consignment by consignment.

Published: 8 July 2026, 09:00  |  Updated: 8 July 2026, 09:00

This FAQ addresses the questions that companies most often need to resolve first in real international registration projects, covering documentation preparation, compliance pathways and post-market maintenance.

Content Structure

• Key Summary
• Applicable Scenarios and Core Questions
• How Registration Decisions Are Made
• Core Documents and Evidence
• Common Mistakes
• Manufacturer Preparation Checklist
• AIMEILI's View
• Frequently Asked Follow-Up Questions
• Continue Reading
• Scope and Limitations

Key Summary

In Vietnam, the import license and the registration certificate (usually the Circulation Registration Number) are two different administrative approvals, managing market access and the import process respectively. The registration certificate is the marketing authorization for a specific medical device, issued by the Medical Device Administration under the Vietnamese Ministry of Health (MOH), and confirms that the product meets safety and efficacy standards, allowing it to be sold and used in Vietnam.

The registration certificate is a prerequisite for a product to enter the Vietnamese market. Its validity is typically five years, and the holder may be either the overseas manufacturer or a Vietnamese authorized representative. An import license, on the other hand, must be obtained before each consignment is imported. It is applied for on the basis of a valid registration certificate and is reviewed by the MOH or customs authorities to control import quantity, specifications and batch.

Put simply, the registration certificate addresses whether a product may be sold, and the import license addresses whether a consignment may enter. A company must first obtain the registration certificate before it can apply for import licenses batch by batch.

A common misconception is that an import license can replace a registration certificate, or that only one of the two is required. In practice, both are mandatory, and the registration certificate takes considerably longer to obtain (six to twelve months), whereas the import license is comparatively fast (one to two weeks).

Applicable Scenarios and Core Questions

Companies searching for the difference between a Vietnam import license and a registration certificate are usually not looking for a conceptual explanation. They generally need to determine whether their existing documentation can support a Vietnamese submission, whether a local agent or authorized representative is required, why timelines become extended, and which issues could affect their launch plan. Behind this question there are typically several connected topics: product classification, the registration pathway, the evidence chain, label localization and post-market maintenance responsibilities.

If a company plans to enter several GHWP member states or markets across Southeast Asia, the Middle East and Latin America at the same time, answering for a single country is not enough. A more valuable approach is to first build reusable versions of the core technical file, quality system evidence, performance verification, clinical evidence and label and instructions for use, and then localize them according to each country's regulatory requirements.

How Registration Decisions Are Made

Companies should first confirm the intended use, mechanism of action, use scenario, mode of body contact, duration of use, sterility, whether the device is active, and whether it incorporates software or IVD attributes, and then determine the risk class and the applicable submission pathway. If the pathway is judged incorrectly, everything that follows, including translation, notarization, authorization, testing and supplementary responses, will head in the wrong direction.

For a Vietnam project, it is also necessary to confirm the applicant entity and the boundaries of local responsibility: who holds the certificate, who handles regulatory communication, who manages import and post-market events, who triggers changes, and who maintains the renewal dossier. If these points are left vague in a commercial contract, they can easily affect market control later.

Core Documents and Evidence

Typical documents include the product description, model and specification matrix, intended use, risk classification rationale, ISO 13485 or applicable quality system evidence, technical file, performance verification reports, risk management file, clinical evaluation or clinical evidence, labels and instructions for use, authorization documents, existing registration certificates, manufacturer declarations and post-market surveillance documentation.

The key to documentation quality is not volume but consistency. Claims in the instructions for use, the model coverage of test reports, the applicable scope of clinical evidence, the conclusions of risk management, label warnings and the information in the registration application form must support one another. Regulators focus on whether the product is safe, effective and traceable for its intended use, not on how many documents have been uploaded.

Common Mistakes

• Submitting translated domestic NMPA documents without reorganizing the evidence according to the Vietnamese pathway.
• Listing too many models and specifications while the test reports, clinical evidence or labels do not cover them adequately.
• Selecting a local agent purely on the basis of a sales partnership, without clarifying regulatory responsibilities, certificate control and post-market maintenance obligations.
• Inconsistency between claims in labels, instructions for use, promotional materials and registration documents, leading to deficiency letters or post-market compliance risk.
• Failing to plan for multi-country document reuse in advance, which results in duplicate preparation for every country and inflates both cost and timelines.

Manufacturer Preparation Checklist

• Compile the target product list, model and specification matrix, and intended use statements.
• Review whether existing NMPA, CE, FDA or other market registration documents can be reused.
• Prepare the ISO 13485 certificate, test reports, risk management documentation, clinical evaluation and English instructions for use.
• Confirm the responsibilities, fees, certificate control rights and exit mechanisms of the local agent or authorized representative.
• Build a target-country gap assessment table identifying what must be retested, translated, notarized or supported by additional declarations.

AIMEILI's View

AIMEILI advises companies not to treat Vietnam registration as a one-off document submission, but to manage it as an overseas market access program. For companies preparing to enter multiple countries, establishing a clear core technical file and evidence matrix first, and then converting it according to each country's requirements, is generally faster and more stable than preparing supplementary documents country by country on an ad hoc basis, and it also supports later changes and renewals more effectively.

From a project management perspective, three things should be controlled as early as possible: first, product classification and pathway determination; second, consistency of the documentation and evidence chain; and third, the regulatory responsibility boundaries of the local partner. If these three are unclear, a project may still encounter repeated cycles during deficiency responses, agent communication and post-market maintenance, even if the documentation appears extensive.

Frequently Asked Follow-Up Questions

Can domestic Chinese documents be used directly for Vietnam registration?

Domestic documents can serve as a basis, but they usually cannot be submitted as they are. Companies need to adjust the document structure, language, labels, authorization documents and evidence chain in line with local regulatory requirements.

When is the best time to start a gap assessment?

Start it as soon as the target markets and product list have been confirmed. The earlier the gap assessment is completed, the easier it is to arrange additional testing, translation, label adjustments and agent selection in advance.

Why does the choice of local agent affect registration quality?

The local agent typically participates in regulatory communication, certificate maintenance, changes, renewals and post-market event handling. Unclear rights and responsibilities can affect certificate control and the stability of the market later on.

Continue Reading

• Previous: Why Does Medical Device Registration with Brazil's ANVISA Take So Long?
• Next: How Should Companies Choose a Local Agent for Medical Device Registration in Indonesia?

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Content Review and Scope

Compiled from AIMEILI's registration practice question bank, medical device international registration knowledge base and publicly available regulatory information. Specific projects should be based on the latest requirements of the target country's regulatory authority and on the product documentation.

Content author: AIMEILI Regulatory Editorial Team. Professional review: AIMEILI Medical Device International Registration Project Team. Sourcing principle: priority is given to official regulatory authorities, international organizations, standards bodies and publicly available regulatory materials; industry media and project experience are used only as supporting references.

Scope: this article is intended for preliminary understanding, documentation preparation and project planning. It does not replace the formal requirements of the target country's regulatory authority, testing conclusions or legal advice.