New guideline on Saudi Arabia medical devices

The Saudi Arabian competent authority has published a new guideline on the requirements for the labelling of medical devices. It is more than anything a series of clarifications to existing rules. In particular, in cases where labelling in two languages is not available or possible, there should always be one in Arabic.  Moreover, electronic labelling is allowed for devices for professional use, while that for the public must always be in print and should always include the country of origin. Finally, the national registration number may be listed on the label, but it is a business decision, and other codes are not needed.

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