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What are the standards for Class B medical device registration with the Vietnam MOH?
Release time：2025-04-07 14:29:36 The author: source:
For Class B medical device registration with the Vietnam Ministry of Health (MOH), compliance with recognized national and international standards is essential to ensure the device's safety, performance, and quality. While Vietnam does not maintain a fixed list of standards for all devices, it adopts or aligns with internationally accepted standards such as those from ISO, IEC, and GHTF/IMDRF.

For Class B medical device registration with the Vietnam Ministry of Health (MOH), compliance with recognized national and international standards is essential to ensure the device's safety, performance, and quality. While Vietnam does not maintain a fixed list of standards for all devices, it adopts or aligns with internationally accepted standards such as those from ISO, IEC, and GHTF/IMDRF.

✅ Core Standards Recognized by Vietnam MOH for Class B Devices

CategoryApplicable StandardsNotes
Quality Management System (QMS)ISO 13485:2016Required for manufacturers
Risk ManagementISO 14971:2019Required in technical dossier
Medical Electrical EquipmentIEC 60601 seriesApplicable if your device uses electricity
BiocompatibilityISO 10993 seriesRequired if the device contacts the human body
Sterilization (if applicable)ISO 11135 / ISO 17665Based on sterilization method
Software (if applicable)IEC 62304For devices with embedded or standalone software
LabelingMOH labeling requirements + ISO 15223-1Vietnamese label and IFU mandatory
Usability EngineeringIEC 62366-1For user interface safety (if relevant)
Electromagnetic Compatibility (EMC)IEC 60601-1-2For electronic devices
Clinical EvaluationBased on GHTF SG5 / MEDDEV 2.7/1 rev.4Not always required for Class B

🧾 Application of Standards in Vietnam

  • Standards are not always mandatory, but strongly recommended to:

    • Demonstrate compliance and safety

    • Streamline approval process

    • Avoid rejection or request for additional data

  • You do not need to submit full standard documents, but must:

    • Provide test reports or certifications based on these standards

    • Refer to applicable standards in the technical documentation

📌 Specific Requirements from MOH

1. ISO 13485 Certificate

  • Required from the manufacturer

  • Must be valid and issued by a recognized certification body

  • Legalized and translated into Vietnamese

2. Test Reports Must Reference Standards

For example:

  • EMC test report → IEC 60601-1-2

  • Biocompatibility → ISO 10993-1, -5, -10

  • Software validation → IEC 62304

🚨 Precautions

  • Use internationally accepted test labs (e.g., SGS, TÜV, Intertek)

  • If your product has a CE Mark, align with EU harmonized standards

  • Vietnam does not yet require product testing in local labs for most Class B devices, unless requested during importation

✅ Summary: Commonly Cited Standards by MOH

StandardPurpose
ISO 13485QMS for manufacturers
ISO 14971Risk management
ISO 10993Biocompatibility
IEC 60601Electrical safety
IEC 62304Software lifecycle
IEC 62366Usability engineering
ISO 15223Labeling symbols
ISO 11135 / 17665Sterilization methods

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