Malaysia Medical Device Regulations

Log into RAMS to download the documents listed below along with more regulations and guidances for Malaysia.

Major Regulations
	Document	Number	Published	Language
Log in	Medical Device Act 2012	737	2/2012
Log in	Medical Device (Exemption) Order 2016		2016	English
Log in	Medical Device Regulations 2012		2012	English

General Guidance Documents
	Document	Number	Language
Log in	How to Apply for Apply for In-Vitro Diagnostic (IVD) Medical Device Registration under Act 737	MDA-GL-IVD-1	English
Log in	How to Apply for Medical Device Registration under Act 737	MDA-GL-MD-01	English
Log in	Conformity Assessment for Medical Device	MDA-GD-0031	English
Log in	Rules of Classification for General Medical Device	MDA-GD-0009	English
Log in	Requirements for Labelling of Medical Devices	MDA-GD-0026	English
Log in	IVD Medical Device Classification System	MDA-GD-0001	English
Log in	Mandatory Problem Reporting	MDA-GD-0014	English

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