Malaysia — Medical Device Regulation
Regulatory body: Medical Device Authority (MDA) — Pihak Berkuasa Peranti Perubatan
Governing legislation: Medical Device Act 2012 (Act 737) · Medical Device Regulations 2012
Registration portal: MyMDA
Official website: www.mda.gov.my
Regulatory Pathway Map
Click a phase to expand — each card links to the relevant section of this guide.
What This Site Covers
This reference covers the full lifecycle of a medical device in the Malaysian market:
| Section | Topics |
|---|---|
| Getting Started | Regulatory framework, MDA overview, product scope, roadmap |
| Device Classification | Class A–D rules, IVD classification, worked examples |
| Establishment Licensing | Manufacturer, importer, distributor licences, LAR requirements |
| Device Registration | Registration routes per class, IVD, renewal, MyMDA portal guide |
| Conformity Assessment | QMS (ISO 13485), technical file, CAB review, MDSAP |
| Post-Market Requirements | PMS, adverse event reporting, FSCA, MPR, PSUR, change notification |
| Special Topics | SaMD, IVDs, custom devices, Special Access Route, ASEAN/AMDD, labelling |
| Reference | Glossary, legislation list, useful links, FAQ |
Key Facts at a Glance
| Parameter | Detail |
|---|---|
| Device classes | Class A (lowest) → Class D (highest) |
| IVD framework | Annex II List A/B + self-test, GHTF SG5-aligned |
| Registration validity | 5 years |
| Establishment licence validity | 1 year (renewed annually) |
| LAR required? | Yes — mandatory for all foreign manufacturers |
| Submission portal | MyMDA |
| ASEAN harmonisation | AMDD · CSDT accepted |
| IMDRF member | Yes |
| MDSAP recognised | Yes |
Where to Start
- New to Malaysian regulation? → Is Your Product a Medical Device? then the Regulatory Roadmap
- Ready to register? → Classification Overview → Establishment Licensing → Device Registration
- Already registered? → Post-Market Requirements
- Foreign manufacturer? → Local Authorised Representative (LAR)
Disclaimer
This site is an independent reference resource and is not affiliated with or endorsed by the Medical Device Authority (MDA) or the Ministry of Health Malaysia. Information is provided for guidance only. Always verify current requirements directly with MDA and via the MyMDA portal.