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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 Approval 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 1 April 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 Third Edition November 2018 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 Fifth Edition 14 June 2022  Click Here
 MDA/GD/0027  Licensing for Establishment Second Edition 30 August 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 Second Edition October 2021 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 First Edition June 2020 Click Here
MDA/GD/0058 Personal Protective Equipment (PPE) - Requirements Second Edition 10 May 2022  Click Here
MDA/GD/0059  COVID-19 RTK (SELF - TEST) - REQUIREMENTS First Edition November 2021 Click Here
MDA/GD/0060 Refurbished Medical Device-Requirements. First Edition January 2022 Click Here
MDA/GD/0061 Classification of Rehabilitation, Physiotherapy and Speech Therapy Device First Edition 1 April 2022  Click Here
MDA/GD/0062

Harmonised Classification of Medical Devices in ASEAN 

First Edition August 2022  Click Here
MDA/GD/0063

Harmonised Borderline Products in ASEAN 

First Edition August 2022  Click Here

23th September 2022

Print

  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb@mda.gov.my

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  • Last Modified: 23 September 2022.
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