Useful Links
Malaysian Regulatory Authorities
| Organisation | URL | Description |
|---|---|---|
| Medical Device Authority (MDA) | www.mda.gov.my | Primary regulator — guidance, alerts, regulatory information |
| MyMDA Portal | mymda.mda.gov.my | Registration, licensing, and post-market submissions portal |
| Ministry of Health Malaysia (MOH) | www.moh.gov.my | Parent ministry for health policy |
| National Pharmaceutical Regulatory Agency (NPRA) | www.npra.gov.my | Regulates pharmaceuticals and cosmetics (not medical devices) |
| Attorney General's Chambers | www.agc.gov.my | Official Malaysian legislation database |
| SIRIM QAS International | www.sirim-qas.com.my | Malaysian conformity assessment and testing body |
| Companies Commission of Malaysia (SSM) | www.ssm.com.my | Company registration |
ASEAN Resources
| Organisation | URL | Description |
|---|---|---|
| ASEAN Secretariat | asean.org | ASEAN harmonisation documents and frameworks |
| ASEAN ACCSQ-MDPWG | asean.org | ASEAN medical device product working group |
International Regulatory Bodies
| Organisation | URL | Description |
|---|---|---|
| IMDRF | www.imdrf.org | International Medical Device Regulators Forum — guidance documents |
| IMDRF MDSAP | www.imdrf.org/working-groups/mdsap | Medical Device Single Audit Programme information |
| TGA (Australia) | www.tga.gov.au | Reference for ARTG and GHTF-aligned guidance |
| Health Canada | www.canada.ca/health-canada | Reference for Canadian medical device regulation |
| HSA (Singapore) | www.hsa.gov.sg | Singapore Health Sciences Authority — ASEAN peer regulator |
| US FDA | www.fda.gov | US Food and Drug Administration |
| EMA / EC | health.ec.europa.eu | EU MDR/IVDR information |
Standards Bodies
| Organisation | URL | Description |
|---|---|---|
| ISO | www.iso.org | International Organization for Standardization |
| IEC | www.iec.ch | International Electrotechnical Commission |
| CLSI | www.clsi.org | Clinical and Laboratory Standards Institute (IVD standards) |
| JCTLM | www.bipm.org/jctlm | Joint Committee for Traceability in Laboratory Medicine |
Useful Tools and Databases
| Resource | URL | Description |
|---|---|---|
| GMDN Agency | www.gmdnagency.org | Global Medical Device Nomenclature code lookup |
| MDA Device Register | Via MyMDA | Search for registered devices and their DRNs |
| MDA Safety Alerts | www.mda.gov.my | Current and historical device safety alerts and recalls |
| IMDRF Documents Library | www.imdrf.org/documents | IMDRF guidance documents library |
Check MDA Website Regularly
MDA publishes updated guidance documents, safety alerts, and regulatory information on its website. Subscribe to MDA notifications or check the website monthly to stay current with regulatory developments.