Malaysia Regulatory Framework Medical Device registration

Malaysian Medical devices regulation basics

Here below are reported some of the most relevant guidance for Medical Device Registration in Malaysian market:

Major Regulations

Medical Device (Exemption) Order 2015
Medical Device Act (english)2012
Medical Device Act (malaysian)2012
Medical Device Authority Act (english)2012
Medical Device Authority Act (malaysian) 2012
Medical Device Regulations 2012

General Guidance Documents

Definition of Medical Device 2014
Essential Principles of Safety and Performance of Medical Devices 2014
Good Distribution Practice for Medical Devices (GDPMD) 2015
Guidelines on Medical Device Registration (Second Edition) 2014
How to Apply for Establishment Licence 2013
How to Apply for IVD Medical Device Registration 2014
IVD Medical Device Classification System 2013
Principles of Conformity Assessment for IVD Medical Devices 2013
Principles of Safety and Performance for IVDs 2013

Specific Guidance Documents

Circular No. 1 – Authorised Representative for Manufacturers 2014
Circular No. 2 – Conformity Assessment Procedures For Devices Approved By Recognised Countries 2014
Circular No. 3 – Exemption of Medical Device from Registration Requirements 2014
Circular No. 4 – Import/Export of Medical Devices 2014
Circular No. 7 – Fast Track Medical Device Registration During Transition Period 2015
Guidance on Change Notification for Registered Medical Device 2018
Guidance on Fast Track Registration During the Transition Period 2015
Guidance on Requirements for Labelling of Medical Devices 2018


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