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Hello RAPS community,
In SFDA's UDI guidance (
G34), there was a clearly-stated requirement for implanted devices to provide an implant card. See page 12 of the guidance:
Manufacturers of implantable devices shall provide an "implant card" to the patient with information allowing the identification of the device, including its UDI.
However, when SFDA changed this guidance to a requirements document (
REQ 7) earlier this year, this statement was removed and now the requirements are more ambiguous, stating only the following (see page 10):
Implantable devices that include a patient Implant card shall contain the device's identification, including its UDI information.
Does the requirement for an implant card exist anywhere outside these documents? Can anyone confirm whether an implant card is still required in KSA?
Thanks for any help!