Penalties & Enforcement
Vietnam has a structured enforcement framework for medical device regulatory violations. Penalties range from administrative fines to criminal prosecution, depending on the nature and severity of the breach.
Administrative penalties — Decree 117/2020/ND-CP
Decree 117/2020/ND-CP on Administrative Sanctions in Health sets out the penalty framework for medical device violations. Common violations and associated penalties include:
| Violation | Penalty range |
|---|---|
| Placing an unregistered/undeclared device on the market | Fine + mandatory suspension or recall |
| Importing without required import permit | Fine up to VND 30–50 million per shipment |
| Non-compliant labelling | Fine + mandatory re-labelling or withdrawal |
| Failure to report an adverse incident within required timeframe | Fine + warning |
| Failure to implement an FSCA within required timeframe | Fine + mandatory action order |
| Obstruction of DAV inspection | Fine + referral for further action |
| Distribution of expired or deteriorated devices | Fine + seizure + withdrawal |
Fines are applied per violation instance and may be compounded where violations are repeated or particularly egregious.
Supplementary penalties and remedies
In addition to fines, DAV and provincial health departments can impose:
- Suspension of import rights for a specified period
- Revocation of the marketing authorisation or declaration
- Mandatory product recall (compulsory FSCA)
- Confiscation of violating goods
- Temporary suspension of business operations in serious cases
Criminal liability
Where a medical device violation results in death or serious injury to patients, criminal liability may arise under Vietnam's Penal Code. Individuals (not just companies) may face criminal prosecution for:
- Manufacturing or trading counterfeit medical devices
- Deliberately placing unsafe devices on the market with knowledge of the risk
- Violating regulations on medical device management causing death or serious harm
Criminal penalties can include substantial fines and imprisonment.
Enforcement authorities
| Authority | Enforcement role |
|---|---|
| DAV (Drug Administration of Vietnam) | Primary enforcement authority at national level |
| Provincial Health Departments (Sở Y tế) | Local market surveillance and enforcement |
| Market Management Authority (Cục Quản lý Thị trường) | Anti-counterfeiting and market surveillance |
| Customs | Enforcement at import/export |
| Police | Criminal investigations for serious violations |
How to respond to an enforcement action
If your organisation receives an inspection notice, violation decision, or enforcement order:
- Engage your Vietnamese Authorised Representative and legal counsel immediately
- Do not obstruct inspectors or fail to provide requested documentation
- Respond formally within the timeframe specified in the enforcement notice
- If disputing a violation decision, use the formal administrative complaint and appeal process
Investing in robust compliance systems — QMS, PMS, FSCA procedures, labelling review — is substantially less costly than managing enforcement actions. Most DAV actions against foreign manufacturers are avoidable with proper regulatory planning.