Singapore Medical Device Regulations

All documents were published by the Health Sciences Authority (HSA) in Singapore and are in PDF format. 

Major Regulations

DocumentLanguageNumberPublished
Health Products (Medical Devices) Regulations 2010en Chap 122D09/2010
Health Products Act 2007en No. 15 of 200703/2007

General Guidance Documents

DocumentLanguageNumberPublished
Guidance on Change Notification for Registered Medical Devicesen GN-21 - Rev 3.22011

Specific Guidance Documents

DocumentLanguageNumberPublished
GN-02 Rev2 Guidance on Licensing for Manufacturers, Importers and Wholesalers of Medical Devices en GN-02 Rev211/2011
Guidance on Grouping of Medical Devices for Product Registrationen GN-12-R101/2011
Guidance on Labelling for Medical Devicesen GN-23 DRAFT08/2009
Guidance on Medical Device Product Registrationen GN-15-R501/2013
Guidance on Preparation fo a Product Registration Submission for In Vitro Diagnostic Medical Devices using the ASEAN CSDTen GN-18 DRAFT 10/2008
Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN CSDTen GN 17 DRAFT05/2014
Guidance on the Change of Registranten GN-24 DRAFT08/2009
Guidance on the Risk Classification of General Medical Devicesen GN-13-R110/2008