With the enforcement of Decree No. 90/2026/ND-CP, Vietnam has strengthened its administrative sanctions for the medical device sector compared to Decree No. 117/2020/ND-CP. To ensure product quality and safety, the updated framework introduces tighter controls across key areas, including risk classification, labeling, documentation, and post-market compliance management.
The highlights below summarize several notable changes only. For further details, please refer to the specific provisions of the relevant decrees.
1. Decree Replaced and Effective Date
Decree No. 90/2026/ND-CP was issued on 30 March 2026 and took effect on 15 May 2026, replacing Decree No. 117/2020/ND-CP on administrative sanctions in the healthcare sector.
2. Key Highlights: Business Risks & Operational Consequences of Non-Compliance
Compared to Decree No. 117/2020/ND-CP, the updated regulations in Decree No. 90/2026/NĐ-CP significantly escalate enforcement, moving beyond mere financial penalties to directly target medical device-related entities' ability to operate in Vietnam.
Regulatory updates across the framework illustrate these severe operational disruptions:
- Immediate Business Halts: If a device's risk classification is incorrect or revoked, authorities may impose restrictions on customs clearance and product circulation. This may lead to a sudden disruption in local supply chain and product availability of related companies.
- Temporary Business Suspension: Authorities have strengthened enforcement of operational restrictions. Failure to promptly execute Field Safety Corrective Actions (FSCA) or to comply with classification revocation requirements will lead to temporary suspension of related business activities.
- Severe Sanctions & Liability: Continued distribution of non-compliant products, especially where patient safety is affected, may result in the most severe administrative and legal sanctions under Vietnamese laws.
- Increased Fines: Financial penalties for compliance failures, including documentation deficiencies, delayed notifications, product circulation violations and operational non-compliance, have also increased compared to Decree No. 117/2020/ND-CP.
3. Recommended Strategic Actions
- Audit Classifications: Periodically verify portfolio alignment with local risk-based classification rules.
- Review Localization: Confirm all Vietnamese product labels and IFUs strictly match registered technical specifications.
- Optimize Update Tracking: Align internal workflows to ensure timely regulatory updates and notification compliance.
- Evaluate Local Partners: Ensure authorized distributors maintain compliant storage and valid technical credentials.
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