The Health Sciences Authority (HSA) Singapore published a minor update to guidance document, GN-32: GUIDANCE on Labelling for Medical Devices Rev 2 (dated September 2022). This update provides alignment to GN-36: Guidance on Medical Device Unique Device Identification (UDI) System mandating the UDI compliance for medical devices in Singapore.
The followings are the added points in several sections of the guidance document:
- Section 2.1 point (l)
The Unique Device Identifier (UDI) should be presented on the medical device labels based on the compliance dates applicable to the medical device based on their risk class as published in the GN-36 Guidance on Medical Device Unique Device Identification (UDI) System (see below table).
| Phase | Category of devices | Compliance Date (subject to revisions) |
| 1. | All Coronary stents, orthopaedic joint replacement implants and Intraocular lens | 1 Nov 2022 |
| 2. | All Class D General medical devices and IVDs | 1 Nov 2024 |
| 3. | All Class C General medical devices and IVDs | 1 Nov 2026 |
| 4. | All Class B General medical devices and IVDs | 1 Nov 2028 |
All Class A General medical devices and IVDs may be implemented on a voluntary basis.
UDI information should be presented in both human readable interpretation (HRI) format and Automated Identification for Data Capture (AIDC) technology forms such as linear bar codes, two-dimensional bar codes, QR codes, RFID. For more information on UDI format and contents, please refer to GN-36 Guidance on Medical Device Unique Device Identification (UDI) System.
- Section 2.1 point (m)
There should be only one machine-readable format on the label. If there are multiple formats present, a clear indication on the applicable machine-readable format to scan and for what purpose should be provided to anyone relying on the capture/use of this format throughout distribution and use, including the provider of care.
- Section 2.2.1 point (d)
Medical devices should be labelled with a UDI on the device package labels and/or directly marked on the devices, where applicable. The UDI format and contents of the label should be based on the requirements as set out in GN-36 Guidance on Medical Device Unique Device Identification (UDI) System.
You can read the full amended guideline here.
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