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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: 

 MDA/RR No. 1 Good Distribution Practice for Medical Devices (GDPMD),  First Revision November 2015
 MDA/GD-01Definition of Medical Device, First Edition March 2014
 MDA/GD-02Essential Principles of Safety & Performance of Medical Device, First Edition March 2014
 MDA/GD-03Common Submission Dossier Template,  First Edition March 2014
 MDA/GD-04The rules of classification for general medical devices,  First Edition March 2014
 MDA/GD-05Product Grouping First Edition October 2013
 MDA/GD/IVD-1IVD Medical Device Classification System First Edition July 2013
 MDA/GD/IVD-2Essential Principles of Safety & Performance of IVD  Medical Device, First Edition July 2013
 MDA/GD/IVD-3 Principles Of Conformity Assessment For In- Vitro Diagnostic (IVD) Medical Devices First Edition July 2013
 MDA/GD/IVD-4Common Submission Dossier Template of IVD Medical Device First Edition July 2013
 MDA/GD/0029Good Refurbishment Practice of Medical Devices (GRPMD) First edition 2016
 MDA/GD/0025Guidance Document Declaration of Conformity First Edition February 2016
 MDA/GD/0027Guidance Document On Licensing for Establishment
 MDA/GD/0026Guidance Document On Requirements For Labelling Of Medical Devices
 MDA/GD/0041Guidance Document On Change of Ownership For Medical Device Registration
 MDA/GD/0020 Guidance Document On Change Notification For Registered Medical Device
Last Updated ( Friday, 20 January 2017 )
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