New Apostille Decree Takes Effect: Implications for Medical Device and Cosmetic Regulatory Dossiers

On July 23, 2026, Vietnam issued Decree No. 293/2026/ND-CP implementing the 1961 Hague Convention Abolishing the Requirement of Legalization for Foreign Public Documents (the Apostille Convention), effective September 11, 2026.

The Convention introduces a simplified process for authenticating eligible foreign public documents, potentially reducing the need for traditional consular legalization. For medical device and cosmetic companies, however, its impact on regulatory dossiers remains uncertain, particularly for Certificates of Free Sale (CFSs), Letters of Authorization (LOAs), and other supporting documents.

How the Apostille Convention Changes Document Legalization

An Apostille certifies the origin of a public document by verifying the authenticity of the signature, the capacity in which the signatory acted, and the identity of any seal or stamp. Where applicable, it replaces the traditional consular legalization process for eligible documents exchanged between countries in which the Convention applies.

However, an Apostille does not verify the substantive content of a document or confirm compliance with the receiving country's regulatory requirements. The Convention also has a defined scope, and certain documents relating to commercial or customs operations may be excluded under applicable provisions.

Impact on Medical Device and Cosmetic Regulatory Dossiers

The Apostille Convention may simplify document authentication for medical device registration and cosmetic product notification in Vietnam. However, its application will depend on the legal nature of each document, its eligibility for an Apostille, and the requirements of the relevant Vietnamese authorities.

Certificates of Free Sale (CFSs)

CFSs are a key area of uncertainty. Although issued by competent authorities, these certificates support product marketing and export activities. Their eligibility for Apostille certification — and the potential application of exclusions for commercial documents — requires clarification.

Letters of Authorization (LOAs) and Manufacturer-Issued Documents

LOAs, declarations of conformity, and other manufacturer-issued documents may require notarization or qualifying official certification before an Apostille can be issued. The applicable process will depend on the document's legal status and the authentication requirements in the country of origin.

Regulatory Compliance Remains Essential

An Apostille does not automatically replace all consular legalization requirements for medical device or cosmetic regulatory dossiers. Companies must assess authentication requirements on a document-by-document basis and continue to meet applicable requirements for document validity, product eligibility, and dossier completeness.

Recommended Actions for Medical Device and Cosmetic Companies

Companies should continue preparing registration and notification dossiers while verifying the authentication requirements for each supporting document. Before switching to the Apostille process, they should confirm that the Convention applies between Vietnam and the country of origin and that the document qualifies for an Apostille.

Clarification from the relevant Vietnamese health authorities is needed on four key issues:

• CFS eligibility: Whether CFSs submitted for medical device registration and cosmetic product notification qualify for Apostille certification.
• Commercial-document exclusions: How exclusions for documents relating directly to commercial or customs activities apply to regulatory dossiers.
• Manufacturer-issued documents: Whether LOAs, declarations of conformity, and other private documents require notarization or additional certification before an Apostille can be issued.
• Existing dossiers: Whether documents already undergoing consular legalization can proceed under the existing process or require alternative authentication.

Pending further guidance, companies with time-sensitive submissions should retain established authentication procedures unless the relevant authority confirms that Apostille certification is acceptable. Where feasible, obtain written confirmation before changing procedures, particularly for documents that are costly or time-consuming to reissue.

This approach supports ongoing dossier preparation while reducing the risk of avoidable certification costs and regulatory delays.

For support with Vietnam medical device registration, cosmetic product notification, and regulatory dossier preparation, Cisema can help your team navigate document authentication requirements, assess dossier readiness, and manage regulatory submissions. To discuss your product registration needs and plan your Vietnam market entry with greater confidence, contact Cisema today.

Further Information

• Explore Cisema’s medical device registration services in Vietnam.
• Learn more about Cisema’s cosmetic product notification services in Vietnam.

Reference

1/ Decree No. 293/2026/ND-CP