The Medical Devices Branch had organized a webinar on the Medical Device (MD) Unique Device Identification (UDI) System in Singapore on 19 October 2020 to provide an introduction to Unique Device Identification (UDI) system for medical devices (MD) and the phased implementation plan for Unique Device Identification in Singapore.
There will be 2 key parts for UDI implementation in healthcare system
PART 1: Making UDI available on the labels of MDs in Singapore
PART 2: Implementing & using the UDI in healthcare system for MD Track and Trace
PART 1: Making UDI available on MDs in Singapore
The approach to implementing the UDI requirement on MD labels for
Singapore is as follows:
1. Accept the UDI barcodes as is that manufacturers have applied on their MD labels for the USA and/or EU (reference agencies) and no Singapore specific UDI will be required for such MDs
2. The UDI information will be captured and published on the Singapore
Medical Device Register (SMDR), an online database for registered medical
devices which is available to the public. Minimum necessary additional UDI related data fields will be incorporated into the current SMDR database
3. Phased implementation approach:
The phase 1 of implementation to start in 2022 (month is not determined yet) to allow for adequate preparation time for all stakeholders
o In Phase 1: Only three types of high-risk implantable MDs will be required to be labeled with UDI – Coronary stents, orthopedic joint replacement implants & Intraocular lens. UDI Information must be submitted to the SMDR and bear UDI on labels.
Singapore Medical Device Register (SMDR) prior to the year 2022.
o The 3 subsequent phases of implementation will start 2 years after each
phase and only medium to high-risk MDs (Class B to D) will require UDI label.
• For low-risk MDs (Class A), UDI will not be mandatory, but can be implemented on a voluntary basis e.g. already labeled in the country of origin
Part 2: Implementing UDI in our healthcare system
MOH, IHiS, ALPS, and HCIs are the key players in implementing Part 2. Full benefits and purpose of UDI implementation will be realized when both
Part 1 and Part 2 of implementation are completed.
For more information, please refer to the HSA website: https://www.hsa.gov.sg/announcements/regulatory-updates/industry-briefing-(october-2020)