Guidance Documents

Guidance Document under Medical Device Act 2012 (Act 737)

These Guidance Documents were prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act 737) and the regulations under it.

This Guidance Document shall be read in conjunction with the current laws and regulations used in Malaysia, which include but are not limited to the following:

Medical Device Act 2012 (Act 737)
Medical Device Regulations 2012

PRE-MARKET MEDICAL DEVICE REGISTRATION (GENERAL MEDICAL DEVICE)

Title	Code	Version Number	Published Date
Guideline on How to Apply for Product Classification Application (Refer Attachment: GD of Product Classification 4th Ver 2025)	MDA/GL/06	Fourth Edition	June 2025
Definition of Medical Device	MDA/GD/0006	First Edition	March 2014
Medical Device - Drugs - Cosmetic Interphase (MDDCI) and Combination Products (Refer Attachment: Table MDDCI 2025)	N/A	N/A	February 2025
Rules of Classification for General Medical Device	MDA/GD/0009	Second Edition	9 May 2022
General Medical Device-Grouping	MDA/GD/0005	Second Edition	30 January 2024
Requirements of Labelling for Medical Devices	MDA/GD/0026	Sixth Edition	21 November 2022
Essential Principles of Safety and Performance of Medical Devices	MDA/GD/0007	First Edition	March 2014
Common Submission Dossier Template (CSDT)	MDA/GD/0008	First Edition	March 2014
Declaration of Conformity (DOC)	MDA/GD/0025	First Edition	February 2016
Change Notification for Registered Medical Device	MDA/GD/0020	Fourth Edition	21 November 2022
Guideline on How to Apply for Medical Device Registration Under Medical Device Act 2012 (Act 737)	MDA/GL/MD-01	Third Edition

Medical Device Specific Requirements

Title	Code	Version Number	Published Date
Medical Face Mask and Respirator	MDA/GD/0033	Third Edition	18th May 2023
Medical Gas System-Requirements for Registration	MDA/GD/0057	Second Edition	9 February 2023
Personal Protective Equipment (PPE)	MDA/GD/0058	Second Edition	27 May 2022
Classification of Rehabilitation, Physiotherapy and Speech Therapy Device	MDA/GD/0061	Second Edition	9 March 2023

PRE-MARKET MEDICAL DEVICE REGISTRATION (IN-VITRO DIAGNOSTIC (IVD) MEDICAL DEVICE)

Title	Code	Version Number	Published Date
Definition of Medical Device	MDA/GD/0006	First Edition	March 2014
In-Vitro Diagnostic (IVD) Medical Device Classification System	MDA/GD/0001	Second Edition	December 2020
Product Grouping for IVD	MDA/GD/0054	Second Edition	January 2021
Requirements of Labelling for Medical Devices	MDA/GD/0026	Sixth Edition	21 November 2022
Essential Principles of Safety and Performance for IVD Medical Device	MDA/GD/0002	First Edition	July 2013
Common Submission Dossier Template (CSDT) of IVD Medical Device	MDA/GD/0004	First Edition	July 2013
Declaration of Conformity (DOC)	MDA/GD/0025	First Edition	February 2016
Change Notification for Registered Medical Device	MDA/GD/0020	Fourth Edition	21 November 2022
Guideline on How to Apply for Apply for In-Vitro Diagnostic (IVD) the Medical Device Registration under Act 737	MDA/GL No. 2

Medical Device Specific Requirements

Title	Code	Version Number	Published Date
Placement Of HIV Self-Test (HIVST) Kit In Malaysia Market	MDA/GD/0065	Second Edition	31 January 2025

ESTABLISHMENT LICENSE

Title	Code	Version Number	Published Date
Good Distribution Practice for Medical Device (GDPMD)	MDA/RR NO. 1	First Revision	1 November 2015
Licensing for Establishment	MDA/GD/0027	Second Edition	23 September 2022
Change of Ownership for Medical Device Registration	MDA/GD/0041	First Edition	December 2016
Guideline on How to apply for establishment License under medical device act 2012 (Act 737)	MDA/GL No. 2

CONFORMITY ASSESSMENT PROCEDURE AND CONFORMITY ASSESSMENT BODY (CAB)

Title	Code	Version Number	Published Date
Conformity Assessment for Medical Device	MDA/GD/0031	First Edition	October 2017
Principles of Conformity Assessment of IVD Medical Devices	MDA/GD/0003	First Edition	July 2013
Conformity Assessment Body (CAB) Requirement for Registration	MDA/GD/0023	First Edition	September 2020
Conformity Assessment Body (CAB) Guide for Conducting Conformity Assessment By Way of Verification	MDA/GD/0068	Second Edition	17 September 2025
Medical Device Registration Submission Guide For Conformity Assessment By Way Of Verification Process And Submission Of Application in MeDC@St Second Edition	MDA/GD/0070	Second Edition	13 October 2025

REFURBISHED MEDICAL DEVICE

Title	Code	Version Number	Published Date
Refurbished Medical Device Requirements	MDA/GD/0060	First Edition	11 February 2022
Good Refurbishment Practice for Medical Device	MDA/GD/0029	First Edition	January 2016

Title	Code	Version Number	Published Date
Code of Advertisement	MDA/GD/0032	Second Edition	March 2021
Guideline on Application for Medical Device Advertisement Approval - Requirements	MDA/GL/04	Second Edition

POST MARKET SURVEILLANCE AND VIGILANCE

Title	Code	Version Number	Published Date
Complaint Handling	MDA/GD/0011	First Edition	June 2020
Distribution Records	MDA/GD/0012	First Edition	June 2020
Field Corrective Action	MDA/GD/0013	First Edition	June 2020
Mandatory Problem Reporting	MDA/GD/0014	First Edition	May 2020
Medical Device Recall	MDA/GD/0015	First Edition	June 2020

MEDICAL DEVICE EXEMPTION

Title	Code	Version Number	Published Date
Notification of Exemption from Registration of Medical Devices for The Purpose of Clinical Research or Performance Evaluation	MDA/GD/0016	First Edition	April 2017
Import And/or Supply of Unregistered Medical Devices for The Purpose of Demonstration for Marketing or Education	MDA/GD/0018	First Edition	November 2019
Special Access-Notification-General requirements	MDA/GD/0043	Second Edition	May 2020
Special Access – Requirements for Ventilator During Emergency Situation	MDA/GD/0056	First Edition	April 2020
Notification for Orphaned Medical Device Note: This guidance document is withdrawn on 7 August. Please refer to circular letter No.2/2022 Control of Orphaned, Obsolete and Discontinued Medical Device in Hospital or Healthcare Facilities Institution or Any Related Facilities.	MDA/GD/0053	First Edition	January 2020
Notification for Obsolete and Discontinue Medical Device Note: This guidance document is withdrawn on 7 August. Please refer to circular letter No.2/2022 Control of Orphaned, Obsolete and Discontinued Medical Device in Hospital or Healthcare Facilities Institution or Any Related Facilities.	MDA/GD/0055	First Edition	16 April 2020
Notification of Custom-made Medical Device	MDA/GD/0064	First Edition	28 February 2023
Importation of Medical Device for Personal Use	MDA/GD/0066	First Edition	30 January 2024
Importation of Medical Device for Re- Export (IRE)	MDA/GD/0069	First Edition	11 Mac 2025

EXPORTATION OF MEDICAL DEVICE

Title	Code	Version Number	Published Date
Requirements for Export Permit	MDA/GD/0024	First Edition	May 2017
-	-	-	-
Notification of Export Only Medical Device Note: This guidance document is under revision.	MDA/GD/0051	First Edition	July 2019

GLOBAL HARMONIZATION REGULATORY DOCUMENTS

Title	Code	Version Number	Published Date
HARMONISED CLASSIFICATION OF MEDICAL DEVICES IN ASEAN	MDA/GD/0062	Third Edition	13 June 2025
HARMONISED BORDERLINE PRODUCTS IN ASEAN	MDA/GD/0063	Third Edition	13 June 2025
MEDICAL DEVICE POST MARKET INFORMATION EXCHANGE FOR ASEAN MEMBER STATES	MDA/GD/0067	First Edition	30 January 2024

Last updated: 24 October 2025