Singapore designates HIBCC as UDI Issuing Agency

Singapore’s Health Sciences Authority (HSA) has designated HIBCC as an Issuing Agency for its Unique Device Identification (UDI) System Regulation. HSA’s UDI regulation adopts the globally recognized principles established by the International Medical Device Regulators Forum (IMDRF), which closely aligns with both the United States (US) Food and Drug Administration’s (FDA) and the European Commission’s (EC) respective UDI requirements. 

HSA’s UDI labeling and database submission requirements will be implemented in phases according tothe medical device risk classification. The first compliance date is November 1, 2022 for Phase 1 devices, and includes Coronary stents, orthopedic joint replacement implants and Intraocular lens.

To view HSA’s UDI System Guidance click here.

To view HSA’s official designation letter click here.