Regulatory Focus™ > News Articles > New Guidance Clarifies Saudi Labeling Requirements for Medical Devices

New Guidance Clarifies Saudi Labeling Requirements for Medical Devices

Posted 17 February 2015 | By Stewart Eisenhart

New Guidance Clarifies Saudi Labeling Requirements for Medical Devices

Content provided by Emergo, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide.

The Saudi Food & Drug Authority (SFDA) has issued new guidance on labeling requirements for medical devices approved for sale in the Kingdom of Saudi Arabia (KSA).

The guidance clarifies labeling rules previously included in the Saudi Medical Devices Interim Regulation more so than adds any new or altered requirements. Among the key clarifications the SFDA mentions are:

  • In cases where dual-language labeling is not available or possible for lay-use devices, labeling should be provided  in Arabic.
  • Electronic labeling is allowed for devices intended for professional use, but labeling for lay-use devices must be provided in paper format.
  • Labeling information must include country of origin.
  • A device’s SFDA Medical Device National Listing Number may be included on its label, but its inclusion is optional; no other SFDA numbers should be on the device label.

A full list of labeling requirements is available in the SFDA guidance document. For additional information on KSA medical device approval and authorized representation requirements, please refer to our regulatory chart on the Saudi device registration process.

 

Original Post: Emergo Blog

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