This Decree deals with administrative violations, penalties, fines, remedial measures against each violation, the power to impose penalties, fines imposed by each authorized title holder and the power to record administrative violations in medical sector.

Administrative violations in medical sector prescribed herein are wrongful acts committed by organizations and individuals that contravene regulations on state management of medical sector but do not constitute criminal offences and are punishable by administrative penalties, including:

  • - Violations against regulations on preventive healthcare, and HIV/AIDS prevention and control;
  • - Violations against regulations on medical examination and treatment;
  • - Violations against regulations on pharmacy and cosmetics;
  • - Violations against regulations on medical devices;
  • - Violations against regulations on health insurance;
  • - Violations against regulations on population.

In which, the medical device sector (Article 72 – 79) includes:

  • - Violations against regulations on classification of medical devices;
  • - Violations against regulations on medical device manufacturing;
  • - Violations against regulations on registration of medical devices;
  • - Violations against regulations on trading in medical devices;
  • - Violations against regulations on import of medical devices;
  • - Violations against regulations on counseling on medical devices;
  • - Violations against regulations on information about medical devices;
  • - Violations against regulations on management and use of medical devices in health facilities.

This decree will be applied for Vietnamese and foreign organizations and individuals. The Primary penalties are warning and fines. Depending on the nature and severity of each administrative violation, the violating entity may face further additional penalties.

 

References:
Decree No. 117/2020/ND-CP on prescribing penalties for administrative violations in medical sector

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