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.