Jul 19, 2022

Singapore’s medical device market regulator, the Health Sciences Authority (HSA), has announced that a new designated issuing agency (IA) has been added to its list of authorized Unique Device Identifier (UDI) partners to assist manufacturers in complying with the country’s new UDI labeling laws. To qualify, an IA must operate a system for UDI issuance which conforms to the relevant international standards set by the International Medical Device Regulators Forum (IMDRF).

HSA adds HIBCC as designated issuing agency for UDI labeling requirements

The HSA has named Health Industry Business Communications Council (HIBCC), as the second approved partner on its designated IA list.

Singapore’s designated IAs are:

·        GS1

·        HIBCC

As we have previously reported, Singapore announced a phased approach to its UDI labeling requirements in 2020, which go into effect later this year for high-risk Class C and Class D devices. HSA guidelines for manufacturers include partnering with an HSA-IA to generate UDI codes and assign them to their devices. UDI barcodes that manufacturers have applied on device labels in the US and EU will be considered valid by the HSA without any need for modification. Information from the labels will be captured and published in the Singapore Medical Device Register (SMDR).

How will the UDI labeling system in Singapore work?

Singapore’s HSA has prepared a number of documents to guide manufacturers in how to comply with its UDI labeling requirements, including:

Phase 1 of UDI implementation includes coronary stents, orthopedic joint replacement implants and intraocular lenses, which must be labeled with UDI by November 1, 2022. You may submit the required UDI information for these registered medical devices via MEDICS.

Related Singapore medical device regulatory resources from Emergo by UL:

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  • Kathryn Burke's picture
    Kathryn Burke

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