Malaysia Medical Device Regulations

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

Major Regulations

DocumentLanguageNumberPublished
Medical Device (Exemption) Order 2015en P.U. (A) 1357/2015
Medical Device Act 2012 en 7372/2012
Medical Device Authority Act 2012 en 7382/2012
Medical Device Regulations 2012 en P.U. (A) 50012/2012

General Guidance Documents

DocumentLanguageNumberPublished
Definition of Medical Deviceen MDA/GD-0103/2014
Essential Principles of Safety and Performance of Medical Devicesen MDA/GD-0203/2014
Good Distribution Practice for Medical Devices (GDPMD)en MDA/RR No 111/2015
Guidelines on Medical Device Registration (Second Edition)en MDA/GL No. 106/2014
How to Apply for Establishment Licenceen MDA/GL No 207/2013
How to Apply for IVD Medical Device Registrationen MDA/GL/IVD-105/2014
IVD Medical Device Classification Systemen MDA/GD/IVD-107/2013
Principles of Conformity Assessment for IVD Medical Devicesen MDA/GD/IVD-307/2013
Principles of Safety and Performance for IVDsen MDA/GD/IVD-207/2013

Specific Guidance Documents

DocumentLanguageNumberPublished
Circular No. 1 - Authorised Representative for Manufacturersen Circular No. 1 of 201405/2014
Circular No. 2 - Conformity Assessment Procedures For Devices Approved By Recognised Countriesen Circular No. 2 of 201405/2014
Circular No. 3 - Exemption of Medical Device from Registration Requirementsen Circular No. 3 of 201405/2014
Circular No. 4 - Import/Export of Medical Devicesen Circular No. 4 of 201405/2014
Circular No. 7 - Fast Track Medical Device Registration During Transition Perioden Circular No. 7 of 20156 April 2015
Guidance on Fast Track Registration During the Transition Perioden MDA/GD - 0001/0012April 2015

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