Malaysia Medical Device Regulations
All were published by the Medical Device Authority of Health Malaysia (MDA) and are in PDF format.
Major Regulations
| Document | Language | Number | Published |
|---|---|---|---|
| Medical Device (Exemption) Order 2015 | en | P.U. (A) 135 | 7/2015 |
| Medical Device Act 2012 | en | 737 | 2/2012 |
| Medical Device Authority Act 2012 | en | 738 | 2/2012 |
| Medical Device Regulations 2012 | en | P.U. (A) 500 | 12/2012 |
General Guidance Documents
| Document | Language | Number | Published |
|---|---|---|---|
| Definition of Medical Device | en | MDA/GD-01 | 03/2014 |
| Essential Principles of Safety and Performance of Medical Devices | en | MDA/GD-02 | 03/2014 |
| Good Distribution Practice for Medical Devices (GDPMD) | en | MDA/RR No 1 | 11/2015 |
| Guidelines on Medical Device Registration (Second Edition) | en | MDA/GL No. 1 | 06/2014 |
| How to Apply for Establishment Licence | en | MDA/GL No 2 | 07/2013 |
| How to Apply for IVD Medical Device Registration | en | MDA/GL/IVD-1 | 05/2014 |
| IVD Medical Device Classification System | en | MDA/GD/IVD-1 | 07/2013 |
| Principles of Conformity Assessment for IVD Medical Devices | en | MDA/GD/IVD-3 | 07/2013 |
| Principles of Safety and Performance for IVDs | en | MDA/GD/IVD-2 | 07/2013 |
Specific Guidance Documents
| Document | Language | Number | Published |
|---|---|---|---|
| Circular No. 1 - Authorised Representative for Manufacturers | en | Circular No. 1 of 2014 | 05/2014 |
| Circular No. 2 - Conformity Assessment Procedures For Devices Approved By Recognised Countries | en | Circular No. 2 of 2014 | 05/2014 |
| Circular No. 3 - Exemption of Medical Device from Registration Requirements | en | Circular No. 3 of 2014 | 05/2014 |
| Circular No. 4 - Import/Export of Medical Devices | en | Circular No. 4 of 2014 | 05/2014 |
| Circular No. 7 - Fast Track Medical Device Registration During Transition Period | en | Circular No. 7 of 2015 | 6 April 2015 |
| Guidance on Change Notification for Registered Medical Device | en | MDA/GD-0020 | 11/2018 |
| Guidance on Fast Track Registration During the Transition Period | en | MDA/GD - 0001/0012 | April 2015 |
| Guidance on Requirements for Labelling of Medical Devices | en | MDA/GD-0026 | 11/2018 |