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)
TitleCodeVersion NumberPublished Date
Definition of Medical Device MDA/GD/0006 First Edition March 2014
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

TitleCodeVersion NumberPublished 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)
TitleCodeVersion NumberPublished 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

TitleCodeVersion NumberPublished Date
Placement Of HIV Self-Test (HIVST) Kit In Malaysia Market MDA/GD/0065 Second Edition 31 January 2025
ESTABLISHMENT LICENSE
TitleCodeVersion NumberPublished 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)
REFURBISHED MEDICAL DEVICE
TitleCodeVersion NumberPublished 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
ADVERTISEMENT
TitleCodeVersion NumberPublished 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
TitleCodeVersion NumberPublished 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
TitleCodeVersion NumberPublished 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
TitleCodeVersion NumberPublished Date
Requirements for Export Permit MDA/GD/0024 First Edition May 2017
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Notification of Export Only Medical Device Note: This guidance document is under revision. MDA/GD/0051 First Edition July 2019
GLOBAL HARMONIZATION REGULATORY DOCUMENTS
TitleCodeVersion NumberPublished 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: 26th March 2025