The Saudi FDA is clarifying expectations for devicemakers when it comes to advertising.
Content must not be misleading in terms of a product’s performance. All advertising and marketing material must be approved by the SFDA before it can be used. Any modification, including translation, will require a new approval, the agency says in guidance released last week.
Importantly, the language used in advertisements depends on the intended audience. Ads should be in English for professionals and in Arabic for lay persons.
In addition, ads must include the device’s name, manufacturer’s contact information, document control reference number and advertising license number.
Ads can be submitted in one of two ways, either by a manufacturer as part of the marketing authorization procedure, or as a separate approval if the material is prepared by a licensed distributor or registered healthcare facility on its behalf.