Vietnam IMDA Portal: Accounts, Classification Publication and Filing
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: Where is a Vietnamese registration filed?
A: On the MOH electronic portal for medical device management (formerly the DMEC portal, now run by IMDA and still using the dmec/imda domain family). The portal serves four functions: (1) publication of classification results; (2) declarations of applicable standards and circulation registration filings; (3) publication of Trading Eligibility Declarations; (4) price declarations and the related publication. Some matters still require a paper dossier to be lodged in person, but publication always happens on the portal.
Q: What are the three most common sticking points on the portal?
A:
- Filing before the classification result is published: Class C/D requires the classification result to be published on the portal first, and a filing without it will be sent back;
- The account holder and the applicant are not the same entity: portal accounts are tied to the Vietnamese legal entity (the MAH), and operating through a distributor’s or consultant’s account creates ownership confusion that is hard to evidence at the next change;
- Missed price declaration: many companies ship as soon as the certificate is issued and overlook the requirement to declare the price before circulation, which is an enforceable breach.
Q: What can be seen on the portal after filing?
A: The status flow of the dossier (acceptance, deficiency notification, resubmission, review, issuance), the content of any deficiency notification, and the details of the issued circulation number. Deficiency notifications are served entirely through the portal (and in writing), so the MAH must set up a daily check routine: the deficiency response window is time-limited (see Part 16 of this guide).
Q: Can portal data be used as verification evidence?
A: Yes, and it should be the primary evidence. The circulation numbers, Trading Eligibility Declarations and price information published on the portal are official first-hand data. When verifying a Vietnamese partner, GRZAN relies solely on what the portal publishes and does not accept screenshots or PDF certificates supplied by the counterparty.
Practical note: have the MAH set the portal notification email and phone to two recipients (the certificate holder and the manufacturer’s nominated contact) and require every notice to be passed on within 24 hours. A missed deficiency window voids the dossier and the fees are not refunded. This is the most avoidable, and most frequent, failure in Vietnamese projects.
Verification checklist (26 October 2026): (1) the functions and publication sections of the MOH/IMDA electronic device portal (imda.moh.gov.vn / dmec.moh.gov.vn); (2) Decision 2495/QĐ-BYT (4 August 2025), list of administrative procedures and handling levels; (3) the Decree 98/2021/NĐ-CP provisions on portal publication (classification, declarations, prices); (4) MOH Notice No. 645/TB-HTTB (2 July 2025).
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.
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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.
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