Post-market & quality control

Marketing authorisation is the start of regulatory attention for a medical device, not the end. Decree 98/2021/NĐ-CP and Circular 05/2022/TT-BYT establish the post-market regime, covering vigilance, incident reporting, recalls, QMS expectations, and routine inspection. Manufacturer/importer obligations: • **Quality management system** — manufacturers must operate a QMS, typically ISO 13485 or an equivalent recognised standard, scoped to cover the devices placed on the Vietnamese market. • **Vigilance and incident reporting** — serious incidents involving death, life-threatening injury, or permanent impairment must be reported to IMDA promptly (timelines specified in Circular 05/2022); broader safety signals are reported on a recurring basis. • **Field safety corrective actions (FSCAs)** — recalls, software updates, and labelling changes must be notified to IMDA and to affected user facilities; importers must document distribution to allow traceability. • **Annual reports** — recurring reports on volume distributed, complaints received, and corrective actions taken. Healthcare-facility obligations under Examination and Treatment Law 15/2023/QH15 and its decrees: • Facilities must maintain medical devices, perform periodic verification, and report adverse incidents through institutional channels that feed into the national vigilance system. • Devices not appearing in IMDA's public database of MACs should not be placed into clinical use. IMDA inspections: • Routine inspections of manufacturers and importers. • Triggered inspections following incident reports, customs alerts, market surveillance findings, or media reports of counterfeit devices. • Inspections of MOH-administered hospitals are coordinated with the Health Inspectorate.

Core framework: • Decree 98/2021/NĐ-CP — Chapters on post-market obligations and inspection. • Decree 07/2023/NĐ-CP — amendments including transitional rules for incident reporting. • Circular 05/2022/TT-BYT — operational rules for vigilance, incident reporting, and recall procedures. QMS reference: • ISO 13485 — Medical devices: Quality management systems. The internationally recognised QMS standard for medical-device manufacturers; Vietnam accepts certificates issued by accredited certification bodies. • ISO 14971 — Application of risk management to medical devices. • Reference-country GMP/QMS certificates from FDA, Health Canada, EU notified bodies, PMDA, TGA, NMPA, MFDS may serve as evidence of QMS compliance. Healthcare-facility use: • Examination and Treatment Law 15/2023/QH15 — effective 1 January 2024. Sets obligations for safe clinical use of medical devices, including periodic verification and adverse-event reporting. Sanctions: • Decree 117/2020/NĐ-CP and Decree 124/2021/NĐ-CP — administrative penalties for medical-device violations in the health sector.

2024–2025 — Counterfeit-device enforcement: IMDA, the Health Inspectorate, and Market Surveillance have run repeated campaigns against counterfeit imaging consumables, refurbished devices sold as new, and unregistered IVD kits. Recall and seizure actions are published on the IMDA portal. 2024 — Examination and Treatment Law in force: Law 15/2023/QH15 took effect on 1 January 2024, adding facility-side obligations on safe use and periodic verification that complement manufacturer/importer vigilance. 2022 — Circular 05/2022 established vigilance and recall mechanics: Set the reporting timelines, format for FSCAs, and template for annual post-market reports under Decree 98/2021.