Singapore Medical Device Regulations
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-R7.3 | 04/2019 |
| Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN CSDT | en | GN-17-R1 | 12/2018 |
| Guidance on Preparation of a Product Registration Submission for In Vitro Diagnostic Medical Devices using the ASEAN CSDT | en | GN-18-R1 | 09/2018 |
| 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 |