Vietnam CFS: Accepted Issuers and Consular Legalisation Rules
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: Is a CFS required for registration in Vietnam?
A: Imported devices require a CFS (Certificate of Free Sale), as evidence that the product is lawfully marketed in its country of origin or a reference country. The CFS serves two purposes in Vietnam: it is a mandatory legal document in the dossier, and it is the qualifying document for the expedited pathway — Class C/D products that hold a CFS or a market authorisation from a reference country’s competent authority can use a shortened review pathway (approximately 10 working days at the shortest).
Q: Which countries’ CFSs are accepted?
A: The reference country and regional authorities listed in Vietnam’s expedited pathway provisions are: US FDA, Australia’s TGA, Health Canada, Japan’s Ministry of Health, Labour and Welfare / PMDA, EU member states, the United Kingdom, Switzerland, China’s NMPA, Korea’s MFDS, and other bodies recognised by the Vietnamese Government. Devices that already hold an import licence, circulation registration number or CFS issued by the Vietnamese Government also qualify.
Q: How does a Chinese manufacturer obtain a CFS?
A: Manufacturers in China normally work from the NMPA registration certificate and apply through the channels for issuing export certificates or certificates of free sale. Two operational points matter: (1) the issuing body must be a competent authority or authorised body under the criteria Vietnam recognises; (2) the certificate must be traceable to the specific models and specifications being filed. Where either point is uncertain, confirm in writing with IMDA through the MAH before filing, rather than relying on experience.
Q: Does the CFS need consular legalisation?
A: An authentication chain is required, but its form changed on 11 September 2026. The Apostille Convention took effect for Vietnam on 11 September 2026:
- Public documents issued in Contracting States now require only an Apostille; consular legalisation is no longer needed;
- Public documents issued in non-Contracting States (for example Germany, Austria and Czechia, which do not yet apply the Convention under transitional arrangements) still require consular legalisation;
- Whichever route applies, a notarised Vietnamese translation remains mandatory.
Q: How should CFS validity be managed?
A: A CFS normally carries an expiry date, and issuing rules differ by country. Deficiencies or refusals caused by validity problems with the CFS, ISO certificate or marketing authorisation are expressly listed in the priority processing provisions of Decree 96/2023, which shows how common the issue is. Track CFS expiry in an annual maintenance register and renew before the expiry date.
Practical note: the biggest trap with a CFS is not that it cannot be obtained, but that what is issued does not match the product being filed. Common errors: the CFS names a product family while the CSDT lists eight models; or the manufacturer name on the CFS differs from the one on the ISO 13485 certificate. Before submission, run a four-document comparison (CFS / ISO 13485 / LoA / CSDT product list); it removes most rejections.
Verification checklist (26 October 2026): (1) Article 32a of Decree 98/2021/NĐ-CP (expedited pathway) and the 07/2023 amendment; (2) Article 147 of Decree 96/2023/NĐ-CP (priority processing, including CFS/ISO/MA validity issues); (3) the date the Apostille Convention took effect for Vietnam (11 September 2026) and the list of Contracting Parties (as published at the time); (4) current MOH/IMDA guidance on acceptable CFS issuing bodies.
Disclaimer
Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.
About GRZAN
GRZAN (Global Regulatory Zone Access Navigator) — the global market-access navigator for medical devices and IVDs.
GRZAN is a specialist consultancy for medical device and IVD market access, providing end-to-end regulatory solutions across the product lifecycle and making international market entry simpler and faster.
Key figures. More than 25 wholly owned subsidiaries worldwide covering 50+ countries and regions; chosen by 100+ listed and leading Chinese device manufacturers, with 4,000+ successful cases; 12+ years in the sector and 200+ regulatory training sessions and seminars delivered.
What we do. Global market access: multi-country registration programmes, technical documentation, regulatory advice. Clinical evidence: clinical evaluation reports (CER), usability studies, overseas clinical investigations. Quality systems: ISO 13485, MDSAP, FDA QMSR and BGMP implementation and audit readiness. Authorised representative and licence-holder services across Southeast Asia, Latin America, the Middle East, Africa, Europe and North America.
Why GRZAN. A real operating entity, with the certificate held by the manufacturer: our direct overseas subsidiaries act as the compliant local holder, so the regulatory relationship stays clear and you keep control rather than being tied to a distributor. Direct access to the team: no time-zone gap, no language barrier, no cultural gap. Review points anticipated: we know what FDA 510(k), EU MDR, Southeast Asian, Latin American and Middle Eastern reviewers look for, which shortens timelines and reduces deficiency letters. Pathway planning: pre-decision analysis and risk assessment before you commit.
Every engagement rests on three commitments: efficiency through pre-submission review, certainty through a clear pathway, and stability through a licence-holder that stays in place.
Take your devices global with GRZAN
We work with manufacturers worldwide to open new markets with a clear regulatory pathway.
Contact us