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:
PRE-MARKET MEDICAL DEVICE REGISTRATION(GENERAL MEDICAL DEVICE) |
|||
Title |
Code |
Version Number |
Published 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 |
| Product Grouping | MDA/GD/0005 | First Edition | October 2013 |
| 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 |
|||
| 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 | Fourth Edition | February 2016 |
| Change Notification for Registered Medical Device | MDA/GD/0020 | Third 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 |
|||
| MDA/GD/0065 | First Edition | 28 August 2023 | |
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 |
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 |
ADVERTISEMENT |
|||
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 | June 2020 |
| Medical Device Recall | MDA/GD/0015 | First Edition | June 2020 |
MEDICAL DEVICE EXEMPTION |
|||
Title |
Code |
Version Number |
Published Date |
| Complaint HandlinNotification 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 | First 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 |
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 | First Edition | 5 September 2022 |
| Harmonised Borderline Products in ASEAN | MDA/GD/0063 | First Edition | 5 September 2022 |
Last updated: 18 September 2023
