Regulatory Open Forum

Eight months after Singapore first announced its plans to establish a Unique Device Identification (UDI) system for medical devices, the country's health regulatory authority has released draft guidance on how the system will work.

 According to the guidance, when the system is fully instituted, all eligible devices distributed and used in the country will include a unique numeric or alphanumeric code on both the device and on its packaging or labeling. The code will be included in a government-maintained registry to improve device traceability and supply chain efficiency.

The system is scheduled to be required first on high-risk implantable devices beginning in 2022, and on medium-risk devices thereafter.  Devices deemed low risk will not be required to have a UDI code. The system is modeled after similar systems in the United States and the European Union and harmonized with principles published by the International Medical Device Regulators Forum (IMDRF),

Where employed, UDI systems have been shown to reduce medical errors,  simplify the integration of device use information into data systems, and permit more rapid identification and resolution of problems and adverse events associated with medical devices.

Eight months after Singapore first announced its plans to establish a Unique Device Identification (UDI) system for medical devices, the country's health regulatory authority has released draft guidance on how the system will work.

 According to the guidance, when the system is fully instituted, all eligible devices distributed and used in the country will include a unique numeric or alphanumeric code on both the device and on its packaging or labeling. The code will be included in a government-maintained registry to improve device traceability and supply chain efficiency.

The system is scheduled to be required first on high-risk implantable devices beginning in 2022, and on medium-risk devices thereafter.  Devices deemed low risk will not be required to have a UDI code. The system is modeled after similar systems in the United States and the European Union and harmonized with principles published by the International Medical Device Regulators Forum (IMDRF),

Where employed, UDI systems have been shown to reduce medical errors,  simplify the integration of device use information into data systems, and permit more rapid identification and resolution of problems and adverse events associated with medical devices.

Eight months after Singapore first announced its plans to establish a Unique Device Identification (UDI) system for medical devices, the country's health regulatory authority has released draft guidance on how the system will work.

 According to the guidance, when the system is fully instituted, all eligible devices distributed and used in the country will include a unique numeric or alphanumeric code on both the device and on its packaging or labeling. The code will be included in a government-maintained registry to improve device traceability and supply chain efficiency.

The system is scheduled to be required first on high-risk implantable devices beginning in 2022, and on medium-risk devices thereafter.  Devices deemed low risk will not be required to have a UDI code. The system is modeled after similar systems in the United States and the European Union and harmonized with principles published by the International Medical Device Regulators Forum (IMDRF),

Where employed, UDI systems have been shown to reduce medical errors,  simplify the integration of device use information into data systems, and permit more rapid identification and resolution of problems and adverse events associated with medical devices.

Eight months after Singapore first announced its plans to establish a Unique Device Identification (UDI) system for medical devices, the country's health regulatory authority has released draft guidance on how the system will work.

 According to the guidance, when the system is fully instituted, all eligible devices distributed and used in the country will include a unique numeric or alphanumeric code on both the device and on its packaging or labeling. The code will be included in a government-maintained registry to improve device traceability and supply chain efficiency.

The system is scheduled to be required first on high-risk implantable devices beginning in 2022, and on medium-risk devices thereafter.  Devices deemed low risk will not be required to have a UDI code. The system is modeled after similar systems in the United States and the European Union and harmonized with principles published by the International Medical Device Regulators Forum (IMDRF),

Where employed, UDI systems have been shown to reduce medical errors,  simplify the integration of device use information into data systems, and permit more rapid identification and resolution of problems and adverse events associated with medical devices.