Singapore Medical Device Regulations

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

Major Regulations


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

General Guidance Documents


Document	Language	Number	Published
Guidance on Change Notification for Registered Medical Devices	en	GN-21 - Rev 4.3	06/2018

Specific Guidance Documents


Document	Language	Number	Published
GN-02 Rev4 Guidance on Licensing for Manufacturers, Importers and Wholesalers of Medical Devices	en	GN-02 Rev4	06/2018
Guidance on Grouping of Medical Devices for Product Registration	en	GN-12-1-R2.1	11/2017
Guidance on Labelling for Medical Devices	en	GN-23-R1	06/2018
Guidance on Medical Device Product Registration	en	GN-15-R7	06/2018
Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN CSDT	en	GN 17 DRAFT	05/2014
Guidance on Preparation of a Product Registration Submission for In Vitro Diagnostic Medical Devices using the ASEAN CSDT	en	GN-18-D1.1 DRAFT	05/2014
Guidance on the Change of Registrant	en	GN-24-R1.2	12/2017
Guidance on the Risk Classification of General Medical Devices	en	GN-13-R2	06/2018