Technical Standards
Vietnam recognises international technical standards as the basis for demonstrating conformity with the essential safety and performance requirements of Decree 98/2021. These are primarily ISO and IEC standards adopted through ASEAN harmonisation.
Essential Principles of Safety and Performanceβ
Decree 98/2021 requires devices to conform to Essential Principles of Safety and Performance β a set of requirements derived from the ASEAN AMDD. Manufacturers demonstrate compliance through:
- Conformance to harmonised technical standards (where available)
- Common Specifications (where harmonised standards are absent)
- Other technically justified methods
Key recognised standardsβ
Quality managementβ
| Standard | Scope |
|---|---|
| ISO 13485:2016 | Quality management systems β medical devices |
| ISO 14971:2019 | Risk management for medical devices |
Biocompatibilityβ
| Standard | Scope |
|---|---|
| ISO 10993 series | Biological evaluation of medical devices |
| ISO 10993-1 | Evaluation and testing within a risk management process |
Sterilisationβ
| Standard | Scope |
|---|---|
| ISO 11135 | Sterilisation using ethylene oxide |
| ISO 11137 series | Sterilisation using radiation |
| ISO 17665 series | Sterilisation using moist heat |
| ISO 11607 series | Packaging for terminally sterilised devices |
Electrical safety and EMCβ
| Standard | Scope |
|---|---|
| IEC 60601-1 | Electrical safety of medical electrical equipment |
| IEC 60601-1-2 | EMC requirements for medical electrical equipment |
| IEC 60601-1-6 | Usability |
| IEC 60601-1-11 | Home healthcare environment |
Softwareβ
| Standard | Scope |
|---|---|
| IEC 62304 | Medical device software β software life cycle processes |
| IEC 62366-1 | Application of usability engineering to medical devices |
IVDβ
| Standard | Scope |
|---|---|
| ISO 18113 series | IVD labelling |
| ISO 15189 | Medical laboratories β requirements |
Vietnam-specific national standards (TCVN)β
Vietnam also has a body of national standards (TCVN β TiΓͺu chuαΊ©n Viα»t Nam) applicable to medical devices. Where a TCVN standard duplicates an ISO/IEC standard, compliance with either is generally acceptable. Check DAV guidance for any mandatory TCVN standards in specific device categories.
The list of recognised standards in Vietnam is updated periodically. Always verify the current list with DAV or your Authorised Representative before finalising your Essential Principles checklist.