Vietnam Prioritised Processing: Decree 96/2023 Eligibility Cases
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: Does Vietnam have an expedited channel?
A: Yes. Its formal name is prioritized processing, introduced by Article 147 of Decree 96/2023/NĐ-CP. It is a separate mechanism from the fast track based on reference-country approval discussed in Part 14: the fast track looks at whether the product has reference-country approval, while prioritized processing looks at whether the file falls into a listed category.
Q: Which situations qualify for prioritized processing?
A: The situations listed by Decree 96/2023 include:
- medical devices manufactured in Vietnam;
- devices for which an import licence application was submitted before 1 January 2022 but not yet granted, and for which a circulation application has been filed;
- chemicals and products used solely for disinfecting medical devices;
- medical devices using new technology approved by the MOH that do not yet hold a circulation number;
- cases where the importer or licence holder changes, or where the name of the manufacturing site or product owner changes with the address unchanged, provided the product code and class stay the same;
- cases where the class is unchanged but the product code changes because a product code has been discontinued;
- applications subject to a deficiency or refusal because of renewal of the validity of the LoA, the ISO 13485 certificate or the marketing authorisation;
- applications subject to a deficiency or refusal because of a change of, or an addition to, the device name.
Q: How is it applied for?
A: Three steps. First, the applicant submits the prioritized processing request form through the DMEC, now IMDA, website, quoting the reference number of the file already submitted. Second, it submits supporting evidence for the relevant category. Third, the MOH reviews and decides within 10 working days of receiving the request and the evidence, and where it refuses, it replies in writing with reasons.
Q: What practical value does it have for manufacturers?
A: Two groups benefit most. The first is manufacturers whose file was refused because the LoA or ISO certificate had expired: such a refusal is in principle repairable, and prioritized processing returns the corrected file to the queue quickly. The second is manufacturers undergoing a change of licence holder or of name: the change does not touch the substance of the product, and priority avoids months in the queue.
Practical note: prioritized processing is application-based and is never applied automatically. When a file is given a deficiency or refused, first check whether it falls into one of the eight categories above. If it does, file the prioritized processing request at once rather than waiting for the deficiency to be resolved. The two steps can run in parallel and save several weeks.
Verification checklist (26 October 2026): (1) Article 147 of Decree No. 96/2023/NĐ-CP (30 December 2023), provisions on prioritized processing; (2) the current text of Article 32 of Decree 98/2021/NĐ-CP; (3) the prioritized processing request form on the DMEC/IMDA website; (4) Article 147.19 of Decree 96/2023/NĐ-CP (Article 30, clinical investigation completion certificate, in force 1 January 2026).
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