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