Medical Translation into Arabic

Medical Devices Labeling Requirements for Saudi Arabia

medical translation ArabicThe 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:

  1. Where labelling is provided in Arabic and/or English, it shall be submitted by the manufacturer.
  2. Where the user of the medical device is :
    • likely to be professionally qualified, labelling shall be in English
    • a lay person, the LABEL and IFU shall be, wherever feasible, in both Arabic and English (including that on any display). Where this is not feasible, the language used on the LABEL and IFU shall be Arabic.

In both situations, the text shall be written in terms readily understood by the intended user, commensurate with their technical knowledge, experience, education or training.

  1. Instructions for the handling, storage, transportation, installation, maintenance and disposal of the medical devices shall be in English and, where justified, in Arabic. The text shall be written in terms readily understood by the intended user, commensurate with their technical knowledge, experience, education or training where such work may be undertaken by persons without medical qualification. Where the device is intended to be used by lay persons, instructions for the handling, storage, transportation, maintenance of the medical devices shall be in both Arabic and English. The text shall be written in terms readily understood by the intended user, commensurate with their technical knowledge, experience, education or training where such work may be undertaken by persons without medical qualification.
  1. Advertising and marketing information shall be in English, or where the device is intended to be used by lay persons, in Arabic.

Medical Devices Labeling Requirements for Saudi Arabia

Many companies struggle to find professional Arabic Translation Services. Arabic is a bidirectional language requiring specialized experience and tools to properly render and publish. Mistakes are commonly made even by respectable companies by underestimating these requirements.


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