Malaysia Medical Device Regulations

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

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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 Published 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