Singapore: UDI starting 2022 for Coronary Stent, Joint Replacement Implants and IOL

PART 1: Making UDI available on MDs in Singapore

Aligned to internationally harmonized principles outlined in the UDI guidance published by the International Medical Device Regulators Forum (IMDRF)

o UDI guidance in 2013 (IMDRF/UDI WG/N7FINAL:2013)

o UDI Application Guide (IMDRF/UDI WG/N48 FINAL:2019)

Adopt a risk-calibrated approach to implementation of UDI

Recognise the following organisation to operate a system for the assignment of Unique Device Identifiers according to specified requirement:

o GS1

o Health Industry Business Communications council (HIBCC)

o International Council for Commonality in Blood Banking Automation (ICCBBA)

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) – 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.

a. SMDR already captures most of the essential data such as intended use, name of product owner, etc for registered MDs

b. SMDR is fit-for-purpose to serve as the database for UDI related information. No new database is required

c. Minimum necessary additional UDI related data fields will be incorporated into our current SMDR database

3. Phased implementation approach:

The phase 1 of implementation to start in 2022 (2 years’ time) to allow for adequate preparation time for all stakeholders

In Phase 1: (High risk implantable MDs – Coronary stents, orthopaedic joint replacement implants & Intraocular lens) - Only three types of high risk implantable MDs will be required to be labelled with UDI

The 3 subsequent phases of implementation will start 2 years after each phase (in 2024 – all other Class D MDs, in 2026 – all Class C MDs and in 2028 – all Class B MDs)

o Only medium to high risk MDs will require UDI label

o For low risk MDs (Class A), UDI will not be mandatory.

-Can be implemented on a voluntary basis e.g. already labelled in country of origin

PART 2: Implementing UDI in our healthcare system

Full benefits and purpose of UDI implementation will be realised when both Part 1 and Part 2 of implementation are completed

Some benefits of adopting UDI in healthcare system include:

o Consistent and efficient recording of MD related information in the hospital IT systems

o Better information flow across the various hospital systems (e.g. procurement, billing, patient records)

o Enable faster tracing of MDs and the affected patients in the event of MD recalls or defects, when HCIs and patients require corrective actions in a timely manner

MOH, IHiS, ALPS and HCIs are the key players in implementing Part 2

Source: HSA - Medical Device (UDI) system in Singapore

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