Legislation & Key Dates
Primary Legislation
| Instrument | Date | Notes |
|---|---|---|
| Medical Device Act 2012 (Act 737) | Gazetted 18 October 2012 | Principal legislation; establishes MDA |
| Medical Device Regulations 2012 | Gazetted 28 December 2012 | Subsidiary regulations; classification, conformity assessment, fees |
| Medical Device (Licensing Exemption) Order | 2013 | Exemption categories |
Commencement Phases
| Phase | Date | Requirements Activated |
|---|---|---|
| Phase 1 | 1 July 2013 | Establishment licensing mandatory |
| Phase 2 | 1 January 2014 | Registration mandatory for Class C and Class D |
| Phase 3 | 1 July 2014 | Registration mandatory for Class A and Class B |
Key Milestones
| Date | Event |
|---|---|
| 2012 | Medical Device Act 2012 (Act 737) enacted |
| July 2013 | Establishment licensing phase commences |
| January 2014 | Class C & D registration mandatory |
| July 2014 | Class A & B registration mandatory |
| 2015 | MyMDA online portal operational for full e-submission |
| 2016 | Malaysia formally participates in ASEAN AMDD framework |
| 2017 | MDA recognises MDSAP audit programme |
| 2019 | Updated guidance on SaMD/digital health published |
| 2021 | ASEAN CSDT (Common Submission Dossier Template) adopted |
| 2023 | Updated MDA guidance on IVD performance evaluation |
Useful References
Check for Updates
Always verify the latest version of any legislation or guidance via the AGC website or directly from MDA.
Add this note at the end of the 'Key Milestones' section: