Unique Device Identification Consultation in Singapore
A Unique Device Identification consultation is underway in Singapore. The Health Sciences Authority (HSA) has issued a draft document entitled “Guidance on the Medical Device Unique Device Identification (UDI) System” so that stakeholders can provide feedback on the document. The consultation is open now until 30 June 2021.
Singapore does not currently have a standardized identification code or system in place to track or identify the distribution and use of medical devices throughout the territory. So, it is necessary to introduce a harmonized identification system for full traceability of medical devices including the timely identification of specific medical devices and patients treated with medical devices affected by recalls, device failures or serious adverse events.
The HSA has decided to adopt the UDI system which is an international system published by the International Medical Device Regulators Forum (IMDRF) and used for the tracking and identification of medical devices.
Key points of the UDI guidance document:
- Unique Device Identifiers that are applied on the medical device labels for the EU or the USA markets will be accepted as is for Singapore.
- Whereas manufacturers or product owners whose medical devices are not marketed in the USA or EU, are required to develop and implement the UDI for Singapore. They should choose an issuing agency designated by the HSA for implementing the UDI system and assign the UDI to their medical devices based on the requirements specified in the guidance document.
- The inclusion of the UDI on device labels is an additional requirement and is not meant to replace any other existing marking or labelling requirements as set out in GN-23 Guidance on Labelling for Medical Devices.
- The UDIs must be in Human Readable Interpretation (HRI) and Automated Identification for Data Capture (AIDC) formats.
- The UDIs must be on device package labels of the smallest unit of supply and on all higher levels of packaging or in some cases directly marked on the devices.
- Medical devices that require product registration and/or are authorized for supply via Special Access Routes (SAR) in Singapore are required to comply with the UDI requirement, this means the devices should be labelled with the UDI prior to supply.
- However, medical devices intended for export only from Singapore and strictly not for supply in Singapore are not required to comply with the UDI requirement.
- Medical devices exclusively for retail Point of Sale (POS) directly to consumers do not need to encode Production Identifiers (PI) in AIDC on the point-of-sale package.
UDI Databases in Singapore:
- The Unique Device Identification Databases (UDID) in Singapore are the existing Singapore Medical Device Register (SMDR) for class B, C and D medical devices, and the Class A Medical Device Database.
- Most of the essential information on the medical devices such as brand name, model identifier, intended use, name of product owner are captured in the SMDR and Class A Medical Device Database. Therefore, only certain UDI data elements will need to be captured to supplement the existing information. For example, UDI-PI shall not be included in either the SMDR or the Class A Medical Device Database, which can be viewed by the public here: http://www.hsa.gov.sg/e-services/infosearch
Phased implementation of the UDI system:
- The HSA is planning a phased implementation of the UDI system in Singapore and has enhanced its online submission system, MEDICS Medical Device Information and Communication System to allow the upload of UDI information.
Proposed Compliance Date for each Implementation Phase:
Category of devices
All Coronary stents, Orthopaedic joint replacement implants and Intraocular lens
1 Nov 2022
All Class D General medical devices and IVDs
1 Nov 2024
All Class C General medical devices and IVDs
1 Nov 2026
All Class B General medical devices and IVDs
1 Nov 2028
· UDIs for Class A General medical devices and IVDs may be implemented on a voluntary basis.
· UDIs will not be required for medical devices for clinical research, investigational testing or clinical trial and custom-made medical devices.
Note: The proposed compliance dates for the various phases are tentative and subject to adjustments based on the progress of the earlier phases of implementation.
The UDI full guidance document
How to submit feedback:
Feedback can be submitted to the HSA using the feedback form.
Learn more about registering medical devices in Singapore here.
We can register your medical device in Singapore. Contact our sales team to find out more at firstname.lastname@example.org