Malaysia Medical Device Regulations
Log into RAMS to download the documents listed below along with more regulations and guidances for Malaysia.
Related services for Malaysia:
- Malaysia authorized representative for medical device firms
- Medical device registration and approval in Malaysia
Related resources:
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | Medical Device Act 2012 | 737 | 2/2012 | |
| Log in | Medical Device (Exemption) Order 2016 | 2016 | English | |
| Log in | Medical Device Regulations 2012 | 2012 | English |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | How to Apply for Apply for In-Vitro Diagnostic (IVD) Medical Device Registration under Act 737 | MDA-GL-IVD-1 | English | |
| Log in | How to Apply for Medical Device Registration under Act 737 | MDA-GL-MD-01 | English | |
| Log in | Conformity Assessment for Medical Device | MDA-GD-0031 | English | |
| Log in | Rules of Classification for General Medical Device | MDA-GD-0009 | English | |
| Log in | Requirements for Labelling of Medical Devices | MDA-GD-0026 | English | |
| Log in | IVD Medical Device Classification System | MDA-GD-0001 | English | |
| Log in | Mandatory Problem Reporting | MDA-GD-0014 | English |
