VIETNAM · MEDICAL DEVICES

Vietnam Medical Device Registration Now Accepts Apostilles: What Manufacturers Need to Know

The Vietnam medical device registration apostille route became available on 11 September 2026, when the Apostille Convention entered into force for Vietnam and Decree 293/2026/ND-CP took effect.

For overseas manufacturers preparing a Vietnam medical device registration, this can remove one of the slower administrative steps in dossier preparation.

Where the Convention is in force between the issuing country and Vietnam, eligible public documents can now be apostilled in the country of origin instead of going through the Vietnamese embassy or consular legalization route.

Vietnam medical device registration apostille: what changed?

Before this change, foreign-issued documents commonly required consular legalization before they could be used in Vietnam. Under the new framework, an apostille issued by the competent authority in the document’s country of origin can satisfy the authentication requirement for documents within the Convention’s scope.

For medical device registration, this is particularly relevant to Certificates of Free Sale and authorization-related documents where apostille treatment is applicable. The main practical benefit is fewer authentication steps before the dossier reaches Vietnam.

What does this mean for CFS and LOA preparation?

Manufacturers should first confirm where the document is issued and whether the Convention is in force between that country and Vietnam. If it is, an eligible document can follow the apostille route rather than traditional consular legalization.

For Vietnam CFS apostille preparation, confirm the Certificate of Free Sale’s issuing authority and whether the document qualifies for an apostille. A Letter of Authorization (LOA) also needs review: its eligibility depends on its form and execution, including any notarization or official certification needed in the issuing country.

The change does not mean that every foreign document automatically qualifies. The document type, issuing authority and country of origin still matter.

Apostille does not remove Vietnam-specific dossier requirements

The new authentication route changes how eligible foreign documents are authenticated. It does not replace the underlying Vietnam medical device registration requirements or certify the content of the document.

Under Decree 293/2026/ND-CP, foreign-language apostilled public documents require a Vietnamese translation that is notarized or certified under Vietnamese law, unless sector-specific rules provide otherwise.

Manufacturers still need the correct registration dossier for the relevant device class, including the applicable administrative, technical, labelling and market-authorization documentation. Apostille simplifies one part of the process; it does not replace registration.

What should manufacturers check before using the apostille route?

The first check is whether the issuing country is a Convention party and whether the Convention is in force between that country and Vietnam. Party status alone is not enough if an objection prevents the Convention from applying between the two countries.

Next, confirm that the specific document is within scope and can be apostilled by the issuing country’s competent authority. Then check the applicable translation, certification and dossier-format requirements.

Foreign public documents from Convention parties that were consular legalized by Vietnamese authorities before the decree took effect remain usable in Vietnam under its transition provisions; an apostille is not required simply to redo that authentication. Document validity and suitability for the current dossier still need to be checked.

Why this matters for Vietnam market entry

Vietnam medical device legalization has often added time before a registration could be filed. Removing the embassy or consular step for eligible documents can make preparation more predictable, particularly for manufacturers coordinating registrations across several ASEAN markets.

It also helps teams plan document authentication alongside the technical dossier. The key is to choose the correct route at the start: apostille and consular legalization should not be treated as interchangeable without checking the country and document involved.

Planning a Vietnam medical device registration?

MediPass supports overseas manufacturers with Vietnam medical device registration, dossier preparation, local regulatory coordination and document review. Learn more about our Vietnam Medical Device Registration services.