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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-01

Definition Of Medical Device, First Edition March 2014

 MDA/GD-02

Essential Principles Of Safety & Performance Of Medical Device, First Edition March 2014

 MDA/GD-03

Common Submission Dossier Template,  First Edition March 2014

 MDA/GD-04

The Rules Of Classification For General Medical Devices,  First Edition March 2014

 MDA/GD-05

Product Grouping First Edition October 2013

 MDA/GD/IVD-1

Ivd Medical Device Classification System First Edition July 2013

 MDA/GD/IVD-2

Essential 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-4

Common Submission Dossier Template Of Ivd Medical Device First Edition July 2013

 MDA/GD/0029

Good Refurbishment Practice Of Medical Devices (Grpmd) First Edition 2016

 MDA/GD/0025

Guidance Document Declaration Of Conformity First Edition February 2016

 MDA/GD/0027

Guidance Document On Licensing For Establishment

 MDA/GD/0026

Guidance Document On Requirements For Labelling Of Medical Devices

 MDA/GD/0041

Guidance Document On Change Of Ownership For Medical Device Registration

 MDA/GD/0020

Guidance Document On Change Notification For Registered Medical Device

MDA/GD/0016

Notification Of Exemption From Registration Of Medical Devices For The Purpose Of Clinical Research Or Performance Evaluation

 

Guideline For Registration Of Drug-Medical Device And Medical Device-Drug Combination Products

 

 

Last Updated ( Tuesday, 18 April 2017 )
 
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