June 2, 2021
Singapore’s Health Sciences Authority (HSA) announced in October 2020 that it would be introducing a Unique Device Identification (UDI) system for medical devices, a story we covered. At that time the agency provided some details about the phased implementation it would use, which would prioritize high-risk implantable devices. It also explained that UDI labeling would only be required for Class B and higher device classes.
A new draft guidance published by the HSA now offers a comprehensive view of the UDI system for manufacturers and importers. It confirms that the system is based on International Medical Device Regulators Forum (IMDRF) principles, as well as that UDIs generated in the EU and US will be accepted as is. It also clarifies that nothing contained in this draft should be interpreted as superseding GN-23, the existing guidance on medical device labeling.
Singapore UDI draft guidance contents and consultation
Included in this draft guidance is information on:
- Basic UDI format, along with human readable interpretation (HRI) format and Automated Identification for Data Capture (AIDC) technology
- UDI labeling requirements in Singapore
- Submitting UDI data elements to relevant databases – the Singapore Medical Device Register (SMDR) for devices of Class B or higher, or (voluntarily) the Class A Medical Devices database for Class A devices
- Adding UDI information for previously registered medical devices
- The phased implementation timeline, which has not changed since the initial announcement
The HSA has opened a public consultation on this draft guidance, lasting from May 25 to June 30 of 2021.
Further medical device regulatory resources for Singapore from Emergo by UL:
- Singapore HSA medical device registration and approval consulting
- Medical device classification in Singapore
- Singapore Registrant in-country representation services
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