August 30, 2021
Singapore’s medical device market regulator, the Health Sciences Authority (HSA), has published final guidance for Unique Device Identification (UDI) regulations covering medical devices sold in the country.
The final HSA guidance as well as an accompanying frequently asked questions (FAQ) document and how-to submission video follow a monthlong feedback period for the regulator’s draft UDI regulation, published earlier in 2021.
Singapore UDI compliance timelines for medical device manufacturers
The HSA has set up a phased implementation schedule for UDI compliance based on device type and risk classification:
- November 1, 2022 for coronary stents, orthopedic joint replacement implants and intraocular lenses
- November 1, 2024 for all Class D (high-risk) general medical devices and in-vitro diagnostic (IVD) products
- November 1, 2026 for all Class C general medical devices and IVDs
- November 1, 2028 for all Class B general medical devices and IVDs
HSA UDI compliance for low-risk Class A devices will be voluntary, according to the guidance. Furthermore, devices intended for clinical trials, clinical research or investigational testing as well as custom-made devices will be exempt from HSA UDI requirements. Devices marketed in Singapore via Special Access Routes, however, will have to comply with UDI rules.
Singapore market registrants selling Class B, C and D devices may begin submitting UDI Device Identifier (UDI-DI) data into HSA's Medical Device Information and Communication System (MEDICS) online submission system on August 31, 2021.
Considerations for Singapore registrants already compliant to US, EU UDI rules
In general, Singapore UDI requirements for medical devices align with principles and guidelines established by the International Medical Device Regulators Forum (IMDRF), which have also been incorporated into UDI systems in other markets such as the US and the European Union (EU).
Accordingly, Singapore market registrants whose devices are already commercialized in the US and/or EU and are already compliant to either of those markets’ UDI regulations may use their existing US or EU UDI labeling information to meet HSA UDI requirements, as well.
Manufacturers of medical devices and IVDs not currently marketed in the US or Europe, on the other hand, will have to follow all steps laid out in the final HSA guidelines, including partnering with an HSA-designated issuing agency to generate UDI codes and assign them to their devices.