Singapore Medical Device Regulations

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

Major Regulations
	Document	Number	Published	Language
Log in	Health Products (Medical Devices) Regulations 2010	Chap 122D	09/2010	English
Log in	Health Products Act 2007	No. 15 of 2007	03/2007	English

Specific Guidance Documents
	Document	Number	Published	Language
Log in	Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices	GN-14-R2		English
Log in	Guidance on the Reporting of Adverse Events for Medical Devices	GN-05-R2.1		English
Log in	Guidance on Medical Device Product Registration	GN-15-R7.4		English
Log in	Guidance on the Risk Classification of General Medical Devices	GN-13-R2-1	09/2018	English
Log in	Guidance on Labelling for Medical Devices	GN-23-R1	06/2018	English
Log in	Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN CSDT	GN-17-R1	12/2018	English
Log in	Guidance on Preparation of a Product Registration Submission for In Vitro Diagnostic Medical Devices using the ASEAN CSDT	GN-18-R1	09/2018	English
Log in	Guidance on the Change of Registrant	GN-24-R1.2	12/2017	English

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