Unique Device Identification Number

What is a Unique Device Identification Number ?

This blog deals with the Unique Identification Number and its guidelines. Singapore’s medical Device Market Regulator, the Health Science Authority (HSA), has published the final guidance for Unique Device identification (UDI) regulations covering medical devices sold in Singapore from 20th October, 2020 . It also talks about the steps to submit UDI information into the Singapore Medical Device Register (SMDR) and Class A Medical Device Database. At present, the International Medical Device Regulator Forum, the FDA and the European Commission are searching for a globally consistent approach to UDI to help optimize patient care by setting up global standards in medical fields.

Rule

The Rule states that all UDI data elements that must be registered as a medical device and the authority must update all the compliance data in accordance with the respective implementation phase and date. 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). All Medical devices are authorised for supply via Special Access Routes (SAR) and have a timeline for implementation as per the UDI requirement. Labels are made available for UDI Carrier and on all higher levels of device packaging or on the device itself. For phasing out old inventory stock with the old UDI label, all medical companies should retain both old and new versions with their respective UDI-DI on the SMDR. A change notification must be submitted to remove the earlier (old) version of UDI-DI label from Singapore Medical Device Register after stock has depleted.

How will this rule help Medical Device Manufacturers ?

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 implementation of UDI, medical device manufacturers will garner significant long-term benefits, including better product traceability, transparency for complaints handling and a system-wide reduction in counterfeit products.

Conclusion

UDI is a global phenomenon for the upcoming years. All Medical Devices/IVD will need to have an UDI, at the first level of packaging. UDI regulations and consultancy are in the last phase of adoption in major international markets, and these laws will have strict compliance deadlines. For Medical Device/IVD Manufacturers selling devices in foreign countries, they need to be familiar with the UDI Rules. Contact Morulaa For Medical Device Consultancy – [email protected].

To stay updated with the latest rules,

Subscribe to our website – https://morulaa.com/