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

Regulation	Year
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

Document	Year
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

Document	Year
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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