Singapore Medical Device Regulations

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

LOG INTO RAMS

 

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