Vietnam Officially Adopts Apostille Certification on 11 September: Farewell to Consular Legalisation
Views:151
Time:2026-09-04 13:46:52

Vietnam deposited its instrument of accession to the Hague Apostille Convention with the Netherlands Ministry of Foreign Affairs (the treaty depositary) on 31 December 2025. The Convention will enter into force for Vietnam on 11 September 2026.

Today marks the final acceptance date for consular‑legalisation submissions for medical‑device registration documents at the Vietnamese Embassy in China. The Vietnamese Government has issued domestic implementing legislation — Decree No. 293/2026/NĐ‑CP — to provide the domestic legal foundation for this policy. Henceforth, Chinese‑origin public documents bearing an Apostille may be submitted directly, replacing the traditional dual‑consular‑legalisation procedure.





https://m.thuvienphapluat.vn/van-ban/linh-vuc-khac/Nghi-dinh-293-2026-ND-CP-thuc-thi-Cong-uocmien-hop-phap-hoa-giay-to-cong-cua-nuoc-ngoai-716104.aspx


一、Policy Background



Vietnam deposited its accession instrument on 31 December 2025 with the depositary, the Netherlands Ministry of Foreign Affairs. Pursuant to Convention rules, the treaty shall take effect for Vietnam on 11 September 2026.On 23 July 2026, the Vietnamese Government promulgated Decree 293/2026/NĐ‑CP, which also enters into force on 11 September 2026. This is Vietnam’s primary domestic legal instrument for implementing the Hague Apostille Convention. It sets out competent issuing authorities, application workflows, transitional‑period rules, document‑verification mechanisms, and specifications for electronic Apostilles.

Upon entry‑into‑force: Public documents issued in China, after notarisation / China Council for the Promotion of International Trade (CCPIT) commercial attestation plus an Apostille (Certificate of Addition) issued by Chinese foreign‑affairs authorities, can be submitted directly to Vietnamese health‑regulatory authorities without further legalisation by the Vietnamese Embassy in China.
Critical ReminderToday is the last day the Vietnamese Embassy in China accepts new applications for consular legalisation for commercial documents,No new dual‑legalisation applications will be accepted by the Embassy after the 11 September 2026 effective date.Documents not submitted to the Embassy before the deadline can no longer go through the traditional consular‑legalisation channel. Please note that an Apostille obtained in advance will result in direct rejection by Vietnamese regulators if submitted before the Convention enters into force, causing registration delays.
Supplementary noteAn Apostille only authenticates the signature and seal on a public document. It does not validate the substance or factual content of the document. Products still need to comply with all target‑market regulatory requirements.

Transitional provisions stipulated under the Vietnamese Decree:
  1. Consular‑legalised documents finalised before 11 September 2026 remain valid in Vietnam; receiving authorities may not compel enterprises to retroactively obtain an Apostille.
  2. Applications for consular legalisation already accepted but not yet finalised by 11 September 2026 may continue processing under the old procedure.
  3. Starting 11 September 2026, public documents originating from Hague‑Convention member states with a valid Apostille shall be exempt from Vietnamese consular legalisation.
二、Documents Affected by the Reform



The following Chinese‑issued documents are subject to the new policy for medical‑device registration, filing and customs clearance in Vietnam:
  • Certificate of Free Sale (CFS) — core mandatory document for Vietnam registration
  • NMPA medical‑device registration / notification certificates
  • Manufacturing licence and business licence
  • Manufacturer’s Letter of Authorization (LOA) appointing a Vietnamese local agent
  • ISO 13485 certificate (with CCPIT commercial attestation)

Important note:CE certificates and ISO 13485 certificates issued by overseas bodies cannot obtain an Apostille within Mainland China. An Apostille must be obtained in the country where the certificate was originally issued. This is a very common pitfall for industry players.
三、Comparison of Old and New Procedures




Three major benefits brought by the Apostille reform:
Shorter turnaround:Removal of embassy‑processing cuts the document‑authentication timeline from 2‑4 weeks down to approximately one week, accelerating time‑to‑market for medical‑device registrations in Vietnam.
Cost savings:Elimination of Vietnamese embassy consular fees delivers significant cost advantages especially for enterprises processing multiple registration documents in bulk.
Multi‑jurisdiction usabilityOne set of Apostille‑certified documents can be reused for submissions to other Hague‑Convention member states, supporting multi‑market expansion strategies.
四、Four Key Risks Medical‑Device Manufacturers Must Watch Out For



(一)Transitional‑window risk (highest probability of error)
9 月 11 日之前递交越南注册的全部材料,必须走使馆双认证,海牙认证不予受理。如果你的注册申报卡在 9 月上旬,稳妥优先,直接继续做传统双认证,不要赌海牙生效。

(二)海牙认证≠免除越南本地合规义务
An Apostille only resolves cross‑border document validity; it does not waive full Vietnamese medical‑device market‑access requirements:
  • Foreign‑language documents still require mandatory Vietnamese translation plus notarisation of translations.
  • Appointment of a locally‑based qualified Vietnamese registration agent remains compulsory.
  • Products still need full MOH‑Vietnam registration / notification, including technical‑document submission, risk classification and quality‑system compliance.

(三)Overseas‑origin certificates cannot be Apostilled in China
CE certificates and ISO 13485 certificates issued overseas cannot receive an Apostille in Mainland China. Obtain the Apostille from the issuing country to avoid wasted efforts with Chinese foreign‑affairs authorities.

(四)Practical‑implementation uncertainty
Even though the Convention enters‑into‑force legally on 11 September 2026, internal IT systems and administrative workflows within Vietnam’s medical‑device authority may need time for adaptation during transition.
Practical tip: For your first submission after 11 September 2026, confirm in advance with your local Vietnamese agent whether regulators are fully ready to accept Apostille‑bearing documents, to prevent rejection caused by system‑readiness gaps.
五、Practical Action Guidance for Medical‑Device Enterprises



Imminent‑submission projects:Stick to traditional embassy‑based consular legalisation for stable filings; refrain from premature Apostille applications.
Planned submissions mid‑September or later:Wait until after 11 September 2026 and apply for Chinese‑issued Apostille certificates to shorten authentication lead‑times.
Advance document planning:Reserve 7‑10 working days for authentication workflows for core documents including CFS, letters of authorisation and registration certificates. Last‑minute applications frequently lead to delays.
Distinguish document origin:Documents issued in China obtain Apostilles in China; overseas‑origin certificates must obtain Apostilles in their country of issuance.
Align with local agent:Confirm document formatting and translation requirements with your qualified Vietnamese agent upfront to avoid dossier rejection.
六、Concluding Remarks



Vietnam’s accession to the Hague Apostille Convention represents a major positive development for Chinese medical‑device manufacturers expanding into Southeast Asia. It addresses long‑standing pain points of slow and costly document legalisation.Nevertheless, policy advantages do not equal regulatory‑compliance shortcuts. Companies must pay close attention to transitional deadlines and local statutory obligations. Mastering these rules will help you translate policy opportunities into real‑world market‑access efficiency.

Should you require further advice, please feel free to contact Wiselink.

Contact Us
Fill Form
Whether you need more information or wish to cooperate with us, we will guide you through every step of the regulatory process. Subscribe to our newsletter for the latest global regulatory updates.