Glossary
Act 737
The Medical Device Act 2012 — the primary legislation governing medical devices in Malaysia.
AMDD
ASEAN Medical Device Directive — the regional harmonisation framework for medical devices across ASEAN member states.
ASEAN
Association of Southeast Asian Nations — the regional intergovernmental organisation of ten Southeast Asian countries.
CAB (Conformity Assessment Body)
An independent body recognised by MDA to assess the conformity of medical devices against the Essential Principles of Safety and Performance. Required for Class C and D technical documentation review.
CAPA (Corrective and Preventive Action)
A quality system element requiring identification, investigation, and correction of non-conformances, and prevention of their recurrence.
CER (Clinical Evaluation Report)
A document summarising the clinical data and evaluation process demonstrating that a device meets clinical performance requirements. Required for Class B, C, and D devices.
CSDT (Common Submission Dossier Template)
The ASEAN-harmonised dossier template for medical device registration across ASEAN member states.
Custom-Made Device
A medical device manufactured in accordance with the written prescription of a qualified medical practitioner for the exclusive use of a specific patient. Exempt from registration under Act 737.
DRN (Device Registration Number)
The unique number assigned by MDA to a registered medical device. Must appear on the device label.
Essential Principles
The fundamental safety and performance requirements that all medical devices must meet, as set out in the Medical Device Regulations 2012.
FSCA (Field Safety Corrective Action)
An action taken by a manufacturer to reduce a risk of death or serious injury associated with a medical device already on the market.
FSN (Field Safety Notice)
A communication sent to customers informing them of a Field Safety Corrective Action and the action required.
GMDN (Global Medical Device Nomenclature)
An internationally standardised naming system for medical devices, administered by the GMDN Agency. GMDN codes are required for Malaysian registration applications.
GHTF (Global Harmonization Task Force)
The predecessor to IMDRF — an international forum that developed foundational medical device regulatory guidance documents, many of which Malaysia's framework is based on.
IFU (Instructions for Use)
The information provided by the manufacturer to inform users of the device's intended purpose, instructions for safe use, and relevant warnings.
IMDRF (International Medical Device Regulators Forum)
International forum of medical device regulators (including MDA) that develops harmonised guidance documents. Successor to GHTF.
IVD (In Vitro Diagnostic medical device)
A medical device used for the examination of specimens derived from the human body, such as blood, urine, or tissue, to provide information about physiological or pathological conditions.
LAR (Local Authorised Representative)
A legal entity established in Malaysia appointed by a foreign manufacturer to act on their behalf for all regulatory purposes in Malaysia. Mandatory for foreign manufacturers placing devices on the Malaysian market.
MDA (Medical Device Authority)
Pihak Berkuasa Peranti Perubatan — the statutory body under the Ministry of Health Malaysia responsible for regulating medical devices.
MDSAP (Medical Device Single Audit Programme)
An IMDRF programme allowing a single audit of a manufacturer's QMS to satisfy the requirements of multiple participating regulatory authorities.
MOH (Ministry of Health Malaysia)
Kementerian Kesihatan Malaysia — the government ministry responsible for health policy in Malaysia, and the parent ministry of MDA.
MPR (Mandatory Problem Reporting)
Malaysia's mechanism for reporting adverse events and device problems to MDA, under Act 737.
MyMDA
The MDA's online portal for regulatory submissions, including establishment licensing, device registration, and post-market reporting.
PMCF (Post-Market Clinical Follow-Up)
A continuing process for systematically collecting clinical data on a registered device to confirm its ongoing safety and performance. Required for Class C and D devices.
PMS (Post-Market Surveillance)
The systematic process of collecting, recording, and analysing data on the quality, safety, and performance of a medical device after market entry.
PSUR (Periodic Safety Update Report)
A structured periodic report submitted to MDA summarising the post-market safety experience and benefit-risk profile of a registered device.
QMS (Quality Management System)
The organisational structure, procedures, processes, and resources needed to ensure that a medical device consistently meets requirements. ISO 13485 is the primary standard.
SaMD (Software as a Medical Device)
Software intended to be used for one or more medical purposes that performs those purposes without being part of a hardware medical device.
SAR (Special Access Route)
MDA's scheme for permitting the use of unregistered medical devices in specific circumstances (compassionate use, emergencies, clinical investigations).
SIRIM QAS International
Malaysia's national standards body and a recognised testing and certification organisation for medical devices.
SSM (Suruhanjaya Syarikat Malaysia)
The Companies Commission of Malaysia — the body with which all Malaysian businesses must be legally registered.
Technical File
The compilation of documents demonstrating that a medical device meets the Essential Principles of Safety and Performance. Required for Class B, C, and D registration.
UDI (Unique Device Identification)
A system for unique identification of medical devices through their distribution and use. Malaysia is monitoring IMDRF UDI guidance for future implementation.