SFDA Compels Companies to Abide by the Requirements of Medical Devices & Products Advertisement
2015-11-30
SFDA compelled companies that intend to advertise their medical devices & products to abide by several requirements, in order to regulate this field and prevent any false alleges and information about the capabilities of the advertised medical devices and products
SFDA issued a guide for licensing of medical devices & products advertisements (Click Here) which includes an application form for licensing of medical devices & products advertisement to be submitted via e-mail: , in order to take the appropriate approval or non-approval decision towards it.
SFDA identified the concept of medical devices & products advertisements, as any written, audio or visual form or any other form aiming to promote, sell or market medical devices and products and also identified the concept of marketing and advertisement materials.
SFDA required that the advertisement or marketing material shall not include any misleading information to users about the capabilities of the medical devices & products specified by the manufacturer and shall not tempt the ordinarily consumer; this also apply to the advertisement information on the internet.
SFDA stressed that the advertisement material and bulletins targeting users of medical devices and products shall contain information that meet their needs. The advertising material shall include information such as: The name of the medical device or product, manufacturer’s name and address, advertisement license number of the medical device or product issued upon SFDA approval of the license application.
The advertisement material shall not contain SFDA’s logo or the national registration number of the organization while it may contain the national listing number of the medical device or product included in its marketing authorization certificate.
Also, SFDA’s requirements provided that the advertisement or marketing material shall be free from any phrases that may be misinterpreted, and that the advertisement or marketing material shall not violate the “Publication Regulations” of the Kingdom. SFDA stressed that the advertisement or marketing material shall be in English language when intended for professionals and shall be in Arabic language when targeting ordinary users.
SFDA noted that the companies which intend to apply for marketing advertisement license for a specific medical device or products shall have the documents that prove its alleges, if the advertisement contained alleges such as (the fastest, the best,..). The evidence documents shall be valid and issued by accredited authorities and shall be in English.
SFDA pointed out that the organizations which are interested in applying for advertisement license for a medical device or product shall provide the national organization registration number and the medical device and products organization licence number (not required for healthcare providers), the national listing number of the medical device or product included in the marketing authorization certificate of the device or product intended to be advertised, together with a copy of the advertisement or marketing material.
