Malaysia Medical Device Regulations

All were published by the Medical Device Authority of Health Malaysia (MDA) and are in PDF format.

Major Regulations


Document	Language	Number	Published
Medical Device (Exemption) Order 2015	en	P.U. (A) 135	7/2015
Medical Device Act 2012	en	737	2/2012
Medical Device Authority Act 2012	en	738	2/2012
Medical Device Regulations 2012	en	P.U. (A) 500	12/2012

General Guidance Documents


Document	Language	Number	Published
Definition of Medical Device	en	MDA/GD-01	03/2014
Essential Principles of Safety and Performance of Medical Devices	en	MDA/GD-02	03/2014
Good Distribution Practice for Medical Devices (GDPMD)	en	MDA/RR No 1	11/2015
Guidelines on Medical Device Registration (Second Edition)	en	MDA/GL No. 1	06/2014
How to Apply for Establishment Licence	en	MDA/GL No 2	07/2013
How to Apply for IVD Medical Device Registration	en	MDA/GL/IVD-1	05/2014
IVD Medical Device Classification System	en	MDA/GD/IVD-1	07/2013
Principles of Conformity Assessment for IVD Medical Devices	en	MDA/GD/IVD-3	07/2013
Principles of Safety and Performance for IVDs	en	MDA/GD/IVD-2	07/2013

Specific Guidance Documents


Document	Language	Number	Published
Circular No. 1 - Authorised Representative for Manufacturers	en	Circular No. 1 of 2014	05/2014
Circular No. 2 - Conformity Assessment Procedures For Devices Approved By Recognised Countries	en	Circular No. 2 of 2014	05/2014
Circular No. 3 - Exemption of Medical Device from Registration Requirements	en	Circular No. 3 of 2014	05/2014
Circular No. 4 - Import/Export of Medical Devices	en	Circular No. 4 of 2014	05/2014
Circular No. 7 - Fast Track Medical Device Registration During Transition Period	en	Circular No. 7 of 2015	6 April 2015
Guidance on Fast Track Registration During the Transition Period	en	MDA/GD - 0001/0012	April 2015