Vietnam Post-Market Obligations: Vigilance, Traceability, Records

Q: Does Vietnam impose post-market surveillance requirements?

A: Yes, and the duty holder is expressly the circulation number holder (MAH). Decree 98/2021/NĐ-CP requires the holder to:

• organise and manage the source traceability of marketed devices and retain complete records relevant to device management;
• handle devices that pose a serious threat to public health or may cause death;
• handle adverse events that have caused harm to user health;
• handle the repair and recall of defective devices;
• handle devices where the Product Owner or the circulation number holder ceases production, becomes insolvent or is dissolved.

Q: Which documents must the MAH retain?

A: Under the post-market documentation requirements of Decree 98, the MAH must retain:

• the LoA issued by the device owner to the organisation applying for circulation;
• a warranty certificate issued by the device owner (except for single-use devices or where no warranty is required);
• the CFS;
• records of adverse events, complaints and corrective actions, stating the brand or product name, type, quantity and batch number of the defective or unsafe device.

Q: What must the importer retain?

A: The importer must keep quality control documents, including the certificate of origin (C/O), the manufacturer’s quality certificate for each batch, device inspection results (as required by Decree 98) and distribution records. These are the first documents examined in an inspection.

Q: How must the vigilance system operate?

A: The core is graded response:

• devices that harm user health: suspend circulation, notify the MOH, distributors and users in writing (stating the batch number and the defect), prepare a corrective or recall plan, and report to the MOH once correction or recall is complete;
• devices presenting a serious public health risk or likely to cause death: publish on the holder’s own website (if any) and notify the relevant bodies and the MOH, suspend circulation, investigate the cause, report to the MOH on receipt of the investigation results (stating the defect and whether it can be corrected), and complete correction or recall and report to the MOH;
• 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.

Q: What does the MOH do at this stage?

A: On receiving the holder’s report, the MOH (acting through IMDA) is responsible for suspending circulation or issuing a recall for the defective batch. It also handles post-licensing inspection, batch suspension and the lifting of suspension, batch recall, and revocation of circulation numbers under Article 39.

Practical note: turn post-market obligations into a responsibility matrix with five roles — who detects, who assigns the grade, who notifies, who executes the recall, who reports to the MOH — and write in the 30-day deadline. Vietnamese inspections usually start from document retention: a missing record is itself a sanctionable violation, whether or not an adverse event actually occurred.

Verification checklist (26 October 2026): (1) Decree No. 98/2021/NĐ-CP, post-market chapter (source traceability and document retention, five handling situations); (2) Decree 98/2021/NĐ-CP, Article 34 (suspension and recall, as amended by Decree 07/2023), Article 37 (whether continued circulation is permitted), Article 38 (as amended by Decree 07/2023, new paragraph 14) and Article 39 (revocation); (3) the 30-day adverse event reporting rule; (4) the MOH delegation decision assigning post-licensing inspection, suspension and recall for Class C/D devices to IMDA.