From 1st November 2022, all medical devices under the closed list of high-risk implantable published in HSA’s guidance document GN-36: Guidance on Medical Device UDI System, that are to be imported and supplied into Singapore are required to be UDI compliant. The categories of devices involved in Phase 1 implementation includes all coronary stents, orthopaedic joint replacement implants, and intraocular lens.
For other categories of devices, UDI implementation will be implemented in various phases based on a risk-calibrated approach. Please refer to GN-36 on the respective UDI compliance dates published in the GN36.
As part of the mandatory UDI implementation, HSA will be adding new condition(s) to the existing medical device registrations and dealer’s licences to reflect the UDI requirement, and companies will be able to view the new condition(s), applicable to different classes of medical devices, via login to HSA’s online system.
Accordingly, HSA has also updated the following guidance documents to include the UDI requirements and the related information (e.g., the definition of UDI, labelling format, and content of UDI):
- GN-16: Guidance on Essential Principles for Safety and Performance of Medical Devices – The update includes the definition of UDI
- GN-23 Guidance on Labelling for Medical Devices
The updated guidance can be found in this weblink: https://www.hsa.gov.sg/medical-devices/guidance-documents”
More details can be found here: https://www.hsa.gov.sg/announcements/regulatory-updates/industry-briefing-(october-2020)