Singapore HSA will introduce UDI labeling requirements for medical devices
Singapore’s Health Sciences Authority (HSA) has announced that it will introduce a Unique Device Identification (UDI) system to be used for medical devices. The announcement came during an industry briefing held on October 19, in which the HSA outlined the reasons for the system and its basic features, going on to discuss plans for its phased implementation.
This decision follows a growing impulse to establish an internationally accepted standard for labeling of medical devices and IVDs. In addition to the US and EU, in which implementation of UDI systems is well underway, regulators in other countries including Brazil, Saudi Arabia, and China have made moves to apply their own UDI requirements for devices.
Singapore HSA will accept UDI labels as-is from US and EU
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 these UDI labels will be captured and published in the Singapore Medical Device Register (SMDR).
UDI labeling will only be required for medium- to high-risk medical devices. It will not be required for low-risk (Class A) medical devices, but these may be voluntarily labeled (for example, if they received UDI labeling in the country of origin).
Phased UDI implementation will begin with high-risk implantable devices
The first phase of UDI labeling implementation will begin in 2022, to be followed by three subsequent phases that will take place in two-year intervals:
2022 – Only for specific high-risk implantable devices, such as coronary stents, orthopedic joint replacement implants, and intraocular lenses
2024 – All other Class D medical devices
2026 – All Class C medical devices
2028 – All Class B medical devices
For devices that will require UDI labeling in the first phase, manufacturers should submit information to the SMDR before the beginning of 2022, and devices will be required to bear UDI labels starting at that time. After the first phase is complete, the HSA will review the results in order to determine whether any changes should be made to the database or the labeling requirements.
The slides from the briefing have been made available for public viewing and can be found here. The HSA also provided a link to a form that interested parties can use to submit feedback and questions.