As part of IMDRF Key Objectives 2021-2025 (Committee, 2020), the utilization of Unique Device Identifier (UDI) System is deemed as important to standardize information collected by regulators via post-market surveillance activities. The United States Food and Drug Administration (US FDA) and the European Commission are amongst countries who have initially established UDI regulations in 2013 and 2017, respectively (GS1, 2021).

The UDI system establishment and implementation, however, varies depending on the local infrastructure readiness and product classification. Most countries will be implementing the UDI system in phases starting with high-risk products.

The table below describes the UDI implementation status for several countries. Some countries also require the manufacturer to submit their UDI information as part of pre-market requirements.

References

Committee, I. M. (2020, September 25). International Medical Device Regulators Forum. Retrieved from International Medical Device Regulators Forum: http://www.imdrf.org/docs/imdrf/final/procedural/imdrf-proc-n39-strategic-plan-200925.pdf

EU, E. C. (2020, August 01). Unique Device Identifier – UDI. Retrieved from European Commission (EU): https://ec.europa.eu/health/sites/default/files/md_topics-interest/docs/md_faq_udi_en.pdf

GS1. (2021, June 29). Unique Device Identification (UDI). Retrieved from https://www.gs1.org/industries/healthcare/udi#udi-in-the-eu

HSA, H. S. (2021, May 25). Health Sciences Authority (HSA). Retrieved from Health Sciences Authority (HSA): https://www.hsa.gov.sg/docs/default-source/hprg-mdb/regulatory-updates/for-consult-guidance-on-udi-system-(25may_pub).pdf

MFDS, M. o. (2019, June 05). Ministry of Food and Drug Safety. Retrieved from Ministry of Food and Drug Safety: https://www.mfds.go.kr/eng/brd/m_40/view.do?seq=72620&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

NMPA, N. M. (2020, September 03). National Medical Products Administration. Retrieved from National Medical Products Administration: https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20200930165228171.html

SFDA, S. F. (2020, September 06). Saudi Food and Drug Authority. Retrieved from Saudi Food and Drug Authority: https://www.sfda.gov.sa/sites/default/files/2020-09/MDS-G34e.pdf

TFDA, T. F. (2020, November 05). Taiwan Food and Drug Administration. Retrieved from Taiwan Food and Drug Administration: https://www.fda.gov.tw/TC/newsContent.aspx?cid=5072&id=26490

 

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