Vietnam Adverse Events and Recall: Article 34 and the 30-Day Rule

Q: What should be done when an adverse event occurs?

A: Handle it in one of three tiers according to the severity of the consequences (post-market provisions of Decree 98):

Q: How exactly is the 30-day rule calculated?

A: All adverse events must be reported to the competent authority and healthcare institutions within 30 days of the date the manufacturer, importer or distributor becomes aware of the event. The clock runs from awareness, not from the occurrence of the event or the completion of the investigation, and this starting point is the most commonly misunderstood.

Q: What does the MOH do after receiving a report?

A: The MOH is responsible for suspending circulation or issuing a recall for the defective batch; Article 37 also sets out the mechanism for the MOH to issue a document on whether continued circulation is permitted. Article 37(6), as amended by Decree 07/2023, provides that where the MOH has issued a document not permitting continued circulation, the circulation number holder or the distributing organisation is responsible for recalling devices on the market (except those already sold to healthcare institutions or users).

Q: What if the Product Owner or holder no longer exists?

A: Decree 98 deals with this situation separately: rules for handling devices when the Product Owner or circulation number holder ceases production, becomes insolvent or is dissolved. This is also a point to weigh when choosing an independent MAH, because the continuation of the holding entity directly affects the continued lawfulness of the device on the market.

Q: Must a recall be publicly announced?

A: Where a serious public health risk or death is involved, the recall must be published on the holder’s website (if any) and notified to the relevant bodies and the MOH. In addition, the “not permitted for continued use” situation under Article 22 is itself an exclusion from the circulation conditions: once listed, the device may not continue to be sold.

Practical note: write the definition of the awareness date into the SOP and document it. The most common failure is that the distributor learns of the event first and the MAH learns weeks later; the starting point is then held to be the distributor’s awareness date, and much of the 30-day window is already gone. The fix is to agree in the distribution agreement that the distributor notifies the MAH in writing within 24 hours of becoming aware of the adverse event, and to treat the MAH’s receipt time as the internal clock (externally, still calculate conservatively from the earliest awareness date).

Verification checklist (26 October 2026): (1) Decree No. 98/2021/NĐ-CP, post-market provisions (three-tier handling and 30-day reporting); (2) Decree 98/2021/NĐ-CP, Article 34 (suspension of circulation and recall); (3) Decree No. 07/2023/NĐ-CP, Article 1(4) (amending Article 37(6) on recall responsibility); (4) Decree 98/2021/NĐ-CP, Articles 37, 38 and 39; (5) the MOH delegation decision assigning batch suspension and recall to IMDA.