On 30 March 2026, the Government of Vietnam issued Decree No. 90/2026/ND-CP governing administrative sanctions in the healthcare sector, replacing previous regulations, notably Decree 117/2020/ND-CP.
The Decree has taken effect since 15 May 2026.
For medical devices, Articles 71 to 80 establish administrative violations and penalties covering key activities across the entire product lifecycle.
Read the full decree here: Decree No. 90/2026/ND-CP on Healthcare Administrative Penalties in Vietnamese
Purpose of the Decree
To establish updated administrative sanctions in the healthcare sector in Vietnam.
To introduce a stricter penalty framework for violations related to medical devices and other healthcare activities.
Scope of Application
For medical devices, the Decree applies to key activities across the product lifecycle, including:
- Classification of medical devices
- Manufacturing activities
- Registration and market authorization
- Trading and distribution
- Importation
- Declaration of materials containing narcotics/precursors
- Technical consultancy services
- Product information, including labeling and Instructions for Use (IFU)
- Management and use at healthcare facilities
- Inspection and inspection-related activities
Key Highlights
Articles 71 to 80 set out administrative violations and penalties for medical device-related activities in Vietnam.
The Decree introduces a comprehensive and stricter penalty framework, with fines ranging from VND 500,000 to VND 100 million, depending on the nature and severity of the violation.
In addition to monetary penalties, supplementary sanctions may apply, including:
- Suspension of licenses or practicing certificates for 1 to 24 months
- Suspension of business operations for 1 to 24 months
- Confiscation of non-compliant products and related materials
Regulatory Focus Areas
The updated framework indicates increased enforcement focus on critical regulatory areas such as:
- Classification accuracy
- Registration compliance
- Labeling requirements, including Vietnamese IFU
- Post-market surveillance (PMS)
Implications to Clients
To mitigate regulatory risks, clients are advised to:
- Review and validate all product classifications and registration status
- Ensure full compliance of labeling and IFU with local Vietnamese requirements
- Strengthen quality management and documentation systems
- Implement or enhance post-market surveillance (PMS) procedures
- Conduct internal compliance audits in preparation for potential regulatory inspections
Effective Date
15 May 2026
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Vietnam, please contact sales@andamanmed.com.