Vietnam Change Management: Notifications or Re-registration
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: What happens if the product changes after the circulation number is issued?
A: The MAH must file a change notification with the competent authority, and the changed device cannot simply be placed on the market. Changes are handled in three tiers:
- Minor changes, such as a change of warranty provider, or a change of labelling or instructions for use that does not alter the intended use, indications, function or performance: once processed the change is published on the portal, and such changes should be made public within 10 days;
- Moderate changes, such as a change of name, a change of the manufacturing site’s name with the address unchanged, or a change of product code because a code has been discontinued: the change procedure applies, and in some cases prioritized processing under Decree 96/2023 is available;
- Major changes, meaning substantive changes to design, materials or intended purpose: re-registration may be required.
Q: What happens if the change is not filed?
A: It is a compliance breach. Where the product information recorded on the circulation number does not match the actual product, the regulator may treat the device as not meeting the conditions for circulation. The consequences include suspension or revocation of the circulation number and a requirement to recall the product. Such mismatches are also a frequent ground for challenge in hospital tenders and distributor audits.
Q: What if the information in the Trading Eligibility Declaration changes?
A: Article 41(2) of Decree 98 provides that where declared information changes in the course of business, the trading entity must notify in writing with the relevant documents and update the declared file published on the portal within three working days of the change. This is a company-side change obligation that runs in parallel with product-side changes, and many manufacturers handle only the product side and miss it.
Q: What kind of change is a switch of MAH?
A: A change of licence holder is one of the categories expressly listed in the prioritized processing provisions of Decree 96/2023, namely a change of importer or licence holder. Note, however, that a Vietnamese circulation number is tied to the entity that actually holds it, so the difficulty of switching MAH depends on whether the outgoing MAH cooperates. This is the core reason for choosing an independent third-party MAH rather than having a distributor hold the registration; see Parts 34 and 35.
Practical note: keep a change trigger list that sets out every change that might arise, covering name, model, manufacturer, manufacturing site, labelling, instructions for use, warranty provider and UDI/DI code, with a handling tier pre-assigned to each. When a change occurs, the first action is not to assess the impact but to check the list and fix the tier. Once that action is standardised, change handling drops from weeks to days.
Verification checklist (26 October 2026): (1) Article 41(2) of Decree 98/2021/NĐ-CP (change to the Trading Eligibility Declaration, update within three working days); (2) Article 147 of Decree 96/2023/NĐ-CP, prioritized processing categories (change of licence holder, change of name or site, change of code); (3) Articles 34, 37 and 39 of Decree 98/2021/NĐ-CP (handling of breaches); (4) the change publication function on the MOH portal, on a 10-day publication basis subject to what is published at the time.
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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