Guidance Documents
Guidance Document under Medical Device Act 2012 ( Act 737)
These Guidance Document was 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 not limited to the following;
a) Medical Device Act 2012 (Act 737); and
b) Medical Device Regulations 2012.
List of guidance documents:
| Code | Title | Version Number | Published Date | Download |
| MDA/RR NO. 1 | Good Distribution Practice for Medical Devices (GDPMD) | First Revision | 1 November 2015 | Click Here |
| MDA/GD/0001 | In-Vitro Diagnostic (IVD) Medical Device Classification System | Second Edition | December 2020 | Click Here |
| MDA/GD/0002 | Essential Principles of Safety and Performance of IVD Medical Devices | First Edition | July 2013 | Click Here |
| MDA/GD/0003 | Principles of Conformity Assessment for In- Vitro Diagnostic (IVD) Medical Devices | First Edition | July 2013 | Click Here |
| MDA/GD/0004 | Common Submission Dossier Template (CSDT) of In- Vitro Diagnostic (IVD) Medical Device | First Edition | July 2013 | Click Here |
| MDA/GD/0005 | Product Grouping | First Edition | October 2013 | Clik Here |
| MDA/GD/0006 | Definition of Medical Device | First Edition | March 2014 | Click Here |
| MDA/GD/0007 | The Essential Principles of Safety and Performance of Medical Devices | First Edition | March 2014 | Click Here |
| MDA/GD/0008 | Common Submission Dossier Template (CSDT) | First Edition | March 2014 | Click Here |
| MDA/GD/0009 | Rules of Classification for General Medical Devices | Second Edition | 9 May 2022 | Click Here |
| MDA/GD/0011 | Complaint Handling | First Edition | June 2020 | Click Here |
| MDA/GD/0012 | Distribution Records | First Edition | June 2020 | Click Here |
| MDA/GD/0013 | Field Corrective Action (FCA) | First Edition | June 2020 | Click Here |
| MDA/GD/0014 | Mandatory Problem Reporting | First Edition | May 2020 | Click Here |
| MDA/GD/0015 | Medical Device Recall | First Edition | June 2020 | Click Here |
| MDA/GD/0016 | Notification of Exemption from Registration of Medical Devices for The Purpose of Clinical Research or Performance Evaluation | First Edition | April 2017 | Click Here |
| MDA/GD/0018 | Import And/or Supply of Unregistered Medical Devices for The Purpose of Demonstration for Marketing or Education | First Edition | November 2019 | Click Here |
| MDA/GD/0020 | Change Notification for Registered Medical Device | Fourth Edition | 21 November 2022 | Click Here |
| MDA/GD/0023 | Conformity Assessment Body (CAB) - Requirement for Registration | First Edition | September 2020 | Click Here |
| MDA/GD/0024 | Requirements for Export Permit | First Edition | May 2017 | Click Here |
| MDA/GD/0025 | Declaration of Conformity (DoC) | First Edition | February 2016 | Click Here |
| MDA/GD/0026 | Requirements for Labelling of Medical Devices | Sixth Edition | 21 November 2022 | Click Here |
| MDA/GD/0027 | Licensing for Establishment | Second Edition | 23 September 2022 | Click Here |
| MDA/GD/0029 | Good Refurbishment Practice of Medical Devices (GRPMD) | First Edition | January 2016 | Click Here |
| MDA/GD/0031 | Conformity Assessment for Medical Device | First Edition | October 2017 | Click Here |
| MDA/GD/0032 | Code Of Advertisement (COA) | Second Edition | March 2021 | Click Here |
| MDA/GD/0033 | Medical Face Mask and Respirator | Third Edition | 18th May 2023 | Click Here |
| MDA/GD/0041 | Change of Ownership for Medical Device Registration | First Edition | December 2016 | Click Here |
| MDA/GD/0043 | Special Access-Notification-General Requirements | Second Edition | May 2020 | Click Here |
| MDA/GD/0045 | Requirements For Application of Certificate of Free Sale (CFS) For Export Only Medical Devices | First Edition | November 2018 | Click Here |
| MDA/GD/0051 | Notification of Export Only Medical Device | First Edition | July 2019 | Click Here |
| MDA/GD/0053 | Notification for Orphaned Medical Device | First Edition | January 2020 | Click Here |
| MDA/GD/0054 | Product Grouping for In-Vitro Diagnostic (IVD) Medical Devices | Second Edition | January 2021 | Click Here |
| MDA/GD/0055 | Notification For Obsolete & Discontinued Medical Device | First Edition | 16 April 2020 | Click Here |
| MDA/GD/0056 | Special Access – Requirements for Ventilator During Emergency Situation | First Edition | April 2020 | Click Here |
| MDA/GD/0057 | Medical Gas System – Requirements for Registration | Second Edition | 9th February 2023 | Click Here |
| MDA/GD/0058 | Personal Protective Equipment (PPE) - Requirements | Second Edition | 27 May 2022 | Click Here |
| MDA/GD/0059 |
COVID-19 RTK (SELF - TEST) - REQUIREMENTS Note: This guidance document is withdrawn on 8 June 2023 |
First Edition | November 2021 | Click Here |
| MDA/GD/0060 | Refurbished Medical Device-Requirements. | First Edition | 11 February 2022 | Click Here |
| MDA/GD/0061 | Classification of Rehabilitation, Physiotherapy and Speech Therapy Device | Second Edition | 9 March 2023 | Click Here |
| MDA/GD/0062 |
Harmonised Classification of Medical Devices in ASEAN |
First Edition | 5 September 2022 | Click Here |
| MDA/GD/0063 |
Harmonised Borderline Products in ASEAN |
First Edition | 5 September 2022 | Click Here |
| MDA/GD/0064 | Notification of Custom-Made Medical Device | First Edition | 28th February 2023 | Click Here |
8th June 2023
