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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:  


Good Distribution Practice For Medical Devices (GDPMD),  First Revision November 2015


Definition Of Medical Device, First Edition March 2014


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


Common Submission Dossier Template,  First Edition March 2014


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


Product Grouping First Edition October 2013


IVD Medical Device Classification System First Edition July 2013


Essential Principles Of Safety & Performance Of IVD Medical Device, First Edition July 2013


 Principles Of Conformity Assessment For In- Vitro Diagnostic (IVD) Medical Devices First Edition July 2013


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


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


Guidance Document Declaration Of Conformity First Edition February 2016


Guidance Document On Licensing For Establishment First Edition May 2016


Guidance Document On Requirements For Labelling Of Medical Devices First Edition November 2015


Guidance Document On Change Of Ownership For Medical Device Registration First Edition December 2016


Guidance Document On Change Notification For Registered Medical Device Second Edition October 2017


Notification Of Exemption From Registration Of Medical Devices For The Purpose Of Clinical Research Or Performance Evaluation First Edition April 2017


Guideline For Registration Of Drug-Medical Device And Medical Device-Drug Combination Products First Edition March 2017


Guidance Document On Requirements For Export Permit First Edition May 2017


Guidance Document Conformity Assessment For Medical Device  First Edition October 2016

Last Updated ( Thursday, 07 December 2017 )
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