MDA & Regulatory Framework
The Medical Device Authority (MDA)
The Medical Device Authority (MDA) — Pihak Berkuasa Peranti Perubatan — is a statutory body under the Ministry of Health Malaysia (MOH) established by the Medical Device Act 2012.
MDA's core functions:
- Registering medical devices for supply in Malaysia
- Issuing and maintaining establishment licences
- Setting and enforcing regulatory standards
- Conducting post-market surveillance and vigilance
- Liaising with ASEAN and international regulatory bodies (IMDRF, AHWP)
Official Website: www.mda.gov.my
MyMDA Portal: mymda.mda.gov.my
Primary Legislation
Medical Device Act 2012 (Act 737)
The principal legislation came into force in phases:
| Phase | Date | Scope |
|---|---|---|
| Phase 1 | 1 July 2013 | Establishment licensing |
| Phase 2 | 1 January 2014 | Registration for Class C & D |
| Phase 3 | 1 July 2014 | Registration for Class A & B |
Act 737 covers definitions, establishment licensing, device registration, conformity assessment, post-market surveillance, and offences.
Medical Device Regulations 2012
Subsidiary legislation specifying classification rules, Essential Principles, conformity assessment procedures, registration requirements, and fees.
Other Relevant Instruments
- Medical Device (Licensing Exemption) Order — exemptions for certain activities
- MDA Administrative and Technical Guidance Notes (AGN/TGN) — non-binding but practically important
Regulatory Principles
Malaysia's framework is aligned with GHTF/IMDRF and the ASEAN Medical Device Directive (AMDD). Key IMDRF documents are adopted by MDA as Malaysian guidance.
Offences and Penalties
| Offence | Maximum Penalty |
|---|---|
| Supplying unregistered device | RM 500,000 and/or 3 years imprisonment |
| Operating without establishment licence | RM 500,000 and/or 3 years imprisonment |
| Failure to comply with post-market obligations | RM 200,000 and/or 2 years imprisonment |
Devices must be registered and establishments must be licensed before any supply activity begins in Malaysia.