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
Deviations from Standards
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.