Recognised Standards
Standards Framework
MDA accepts compliance with internationally recognised standards as a primary means of demonstrating conformity with the Essential Principles of Safety and Performance. Compliance with a listed standard creates a presumption of conformity with the corresponding Essential Principle(s).
Malaysia aligns its standards acceptance with IMDRF, ISO, IEC, and ASEAN frameworks. Malaysian Standards (MS) equivalent to ISO/IEC standards are also accepted.
General / Cross-Cutting Standards
| Standard | Title | Applicability |
|---|---|---|
| ISO 13485:2016 | Medical devices — Quality management systems | All manufacturers |
| ISO 14971:2019 | Application of risk management to medical devices | All device classes B–D |
| IEC 62366-1:2015 | Usability engineering | Devices with user interface |
| ISO 15223-1:2021 | Symbols for medical devices | All devices (labelling) |
| ISO 10993 series | Biological evaluation of medical devices | Devices with patient contact |
| IEC 62304:2006+AMD1 | Medical device software lifecycle | Software-containing devices |
| ISO 11135:2014 | Sterilization — EO | EO-sterilised devices |
| ISO 11137 series | Sterilization — Radiation | Radiation-sterilised devices |
| ISO 11607 series | Packaging for terminally sterilised devices | Sterile devices |
Active Device / Electro-Medical Equipment Standards
| Standard | Title |
|---|---|
| IEC 60601-1:2005+AMD2 | Medical electrical equipment — General safety and performance |
| IEC 60601-1-2:2014 | Electromagnetic disturbances (EMC) |
| IEC 60601-1-6 | Usability |
| IEC 60601-1-8 | Alarm systems |
| IEC 60601-1-9 | Environmentally conscious design |
| IEC 60601-1-11 | Home healthcare environment |
| IEC 60601-2-xx | Particular requirements (numerous device-type standards) |
IVD Standards
| Standard | Title |
|---|---|
| ISO 13612 series | IVD performance evaluation |
| ISO 15189:2022 | Medical laboratories requirements |
| ISO 18113 series | IVD labelling |
| ISO 5725 series | Accuracy of measurement methods |
| ISO 17511:2020 | Metrological traceability of values assigned to calibrators |
| EP09 (CLSI) | Measurement procedure comparison |
| EP05 (CLSI) | Precision evaluation |
Implant Standards (Selected)
| Standard | Title |
|---|---|
| ISO 5832 series | Implants for surgery — Metallic materials |
| ISO 10993 series | Biological evaluation |
| ASTM F2026 | UHMWPE for orthopaedic implants |
| ISO 14242 series | Wear of total hip joint replacements |
Software and Cybersecurity
| Standard | Title |
|---|---|
| IEC 62304:2006+AMD1:2015 | Software lifecycle processes |
| IEC 62443 series | Industrial automation and control systems security |
| ISO/IEC 27001 | Information security management |
| IMDRF/CYBER WG/N60 | Principles and practices for medical device cybersecurity |
How to Apply Standards
- Identify all Essential Principles applicable to your device
- For each Essential Principle, identify the most current applicable standard(s)
- Verify compliance through testing, design analysis, or other means
- Document compliance (or justified partial compliance) in the Essential Principles checklist in the technical file
If you cannot fully comply with a standard, document the deviation and provide an alternative means of demonstrating compliance with the corresponding Essential Principle. Unjustified deviations are a common cause of MDA queries.
If partial compliance is claimed, provide documented risk assessment and technical justification for each deviation. Waivers must be justified by design necessity or equivalence to the Essential Principle. Unsupported deviations are a frequent source of deficiency letters and may result in rejection.