Legislation & Guidance Documents

Primary Malaysian Legislation

Document	Description	Source
Medical Device Act 2012 (Act 737)	Principal legislation governing medical devices in Malaysia	Attorney General's Chambers (AGC)
Medical Device Regulations 2012	Subsidiary regulations — classification, conformity assessment, fees	AGC / MDA
Medical Device (Licensing Exemption) Order	Exemption categories from licensing requirements	AGC / MDA

All official Malaysian legislation is available from the Attorney General's Chambers (AGC) — search for "Medical Device" in the Federal legislation database.

MDA Administrative Guidance Notes (AGN)

MDA publishes Administrative Guidance Notes to clarify procedural and administrative aspects of device regulation. Key AGNs include:

AGN	Topic
AGN-001	Application for Establishment Licence
AGN-002	Application for Device Registration
AGN-003	Variation of Establishment Licence
AGN-004	Variation of Device Registration
AGN-005	Renewal of Device Registration
AGN-006	Post-Market Surveillance and Vigilance
AGN-007	Custom-Made Devices
AGN-008	Clinical Investigation

Note: AGN numbering may have been updated. Verify current AGNs at www.mda.gov.my.

MDA Technical Guidance Notes (TGN)

Technical Guidance Notes address specific technical topics:

TGN	Topic
TGN-001	Classification of Medical Devices
TGN-002	Essential Principles of Safety and Performance
TGN-003	Clinical Evaluation
TGN-004	Software as a Medical Device
TGN-005	IVD Performance Evaluation
TGN-006	Sterility and Sterilisation
TGN-007	Biocompatibility
TGN-008	Labelling of Medical Devices

Adopted GHTF / IMDRF Guidance

Malaysia adopts GHTF and IMDRF guidance documents as the basis for its technical requirements:

Document	Topic
GHTF/SG1/N045:2008	Principles of Medical Device Classification
GHTF/SG1/N071:2012	Registration of Medical Devices
GHTF/SG2/N54:2006	Medical Device Post Market Surveillance
GHTF/SG2/N47:2005	Vigilance System for Medical Devices
GHTF/SG3/N99-10:2004	Quality Management Systems
GHTF/SG5/N1R8:2007	Clinical Evaluation
IMDRF/SaMD WG/N10FINAL:2013	Software as a Medical Device — Key definitions
IMDRF/SaMD WG/N12FINAL:2014	Software as a Medical Device — Risk categorisation
IMDRF/MDCE WG/N56FINAL:2019	Clinical Evaluation
IMDRF/CYBER WG/N60FINAL:2020	Cybersecurity for medical devices
IMDRF/UDI WG/N7FINAL:2013	UDI — Unique Device Identification

ASEAN Guidance Documents

Document	Topic
ASEAN AMDD	ASEAN Medical Device Directive (framework document)
ASEAN CSDT	Common Submission Dossier Template
ASEAN Labelling Guidelines	Harmonised labelling requirements
ASEAN Post-Market Vigilance Guidelines	Harmonised vigilance framework

ASEAN guidance is available from the ASEAN Secretariat and the ASEAN Consultative Committee for Standards and Quality — Medical Device Product Working Group (ACCSQ-MDPWG).

Standards

See Recognised Standards for the full standards list.