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Beyond the healthcare pages our lawyers share with you multi-sector insights where you will discover articles on Dubai’s DIFC regulatory framework for startups, Bahrain’s commercial agencies law, and we also shed light on Kuwaiti civil code and the advantages of setting up a joint stock company in Saudi Arabia.Read the full edition
The Saudi Food and Drug Authority (“SFDA”) issued a new version of the Requirements for Advertisement Approval and Launching Awareness and Charity Campaigns for Medical Devices (Version 3) (“MDS-REQ 8”) on 15/03/2023. MDS-REQ 8 aims to clarify the procedures for obtaining SFDA approval for advertisement activities in relation to medical devices, and using medical devices within awareness or charity campaigns in Saudi Arabia. However, the requirements of MDS-REQ 8 does not apply to medical devices that are imported into KSA for only display or training purposes, as these are covered by a different SFDA guidance document.
This article examines the requirements of MDS-REQ 8 and provide analyses regarding the position of medical device companies in KSA as a result of the issuance of these requirements by the SFDA.
In order to publish promotional or advertising material related to medical devices, prior approval must be obtained from the SFDA. This approval is required whether the advertisement is intended for healthcare professionals or the general public. Further, the medical device being advertised must have a Medical Device Marketing Authorization (“MDMA”) obtained from the SFDA.
The material of the advertisement must include the following information:
Moreover, medical device advertisements must not contain anything that goes against Islamic Sharia law, public decency, or societal norms. The advertising material cannot have any misleading information that contradicts the manufacturer’s claims or contain phrases that could be misunderstood by the intended audience. In addition, medical device advertisements cannot offend or include comparisons to other medical devices, contain any claims that have not been approved by the SFDA, and the SFDA’s name or logo may not be used in the content of the advertisement. The advertisement materials must not violate any laws in Saudi Arabia, including the Law of Printed Materials and Publication issued by Royal Decree no. M/32 dated 29/11/2000.
In relation to the language of the advertisement, MDS-REQ 8 requires that the language to be used in the advertisement is Arabic if it is directed to the general public. If the advertisement is directed to healthcare professionals, then English must be used.
Furthermore, the entity responsible for the advertisement may appoint a licensed advertisement agency to submit the application for approval on its behalf. Ultimately, manufacturers and authorized representatives of the advertised medical device are responsible for ensuring that all advertisement materials have gained prior approval from the SFDA, and to provide distributors and importers of medical devices with a copy of all approved advertisement materials.
MDS-REQ 8 regulates digital advertisements of medical devices, and requires obtaining prior approval from the SFDA for any advertisement material directed to the public, whether it is on a website or social media platform registered inside or outside KSA. This approval requirement applies to both individuals and establishments.
The advertisement must be available on the website or social media platform itself and not through external links. Also, it is not allowed to provide information directed to healthcare professionals on platforms that are meant for the general public.
If an individual publishes advertisements on social media platforms, the SFDA must be notified via email at least 12 hours before publishing the advertisement. The advertiser’s name, social media account, and the date of publication must be provided as part of the notification.
Additionally, responses to inquiries on advertisement material published on social media platforms must not include any information that has not been previously approved by the SFDA. For live video or audio advertisements, a copy of the script must be submitted as a part of the advertisement material that is to be approved by the SFDA.
For individual advertisements, a contract must be concluded between the establishment and the individual advertiser. Further, both parties must keep a copy of the contract, and it must be included within the documents attached to the application. The contract must include the following information:
Firstly, permission must be granted by the SFDA to organize awareness and charity campaigns in which medical devices will be used, displayed or distributed. The SFDA application process for organizing awareness and charity campaigns includes submission of the following documents:
Two methods of submission are available, which are the following:
Upon fulfilling the above requirements and submitting the application, the SFDA will review the application and provide a decision within an estimated ten days.
Moreover, certain requirements in relation to the campaign itself must be fulfilled in order to ensure adherence to the regulations set by the SFDA. The requirements include obtaining an MDMA from the SFDA for the medical device to be used, displayed, or distributed during the campaign. The campaign must be led by a competent and qualified person and should not include any marketing references or commercial advertising materials.
Additionally, MDS-REQ 8 states that medical devices should not be used on participants, attendees, or the general public during the campaign unless the participant or guardian consents and signs the required declaration form. Furthermore, free samples of the medical device cannot be distributed for marketing purposes to participants or attendees during the campaign.
With regard to the language to be used in the campaign, if it is intended for healthcare professionals, the SFDA requires the material to be provided in English. On the other hand, if the campaign is targeted for the general public, it should be in Arabic and will need to consider the needs of people with disabilities. Also, MDS-REQ 8 states that any other conditions required by the SFDA and published on its website from time to time must be followed.
In conclusion, the guidelines contained within MDS-REQ 8 provide clear procedures for obtaining SFDA approval for medical device advertisements and organizing awareness and charity campaigns in Saudi Arabia. The guidelines require adherence to specific requirements, such as obtaining SFDA approval for all medical device advertisements and obtaining consent before using medical devices on participants or attendees during campaigns. By following these guidelines, medical device companies can ensure that their advertisement and campaigns will be in accordance with the laws in KSA.
This alert was prepared by Abdulmohsen AlSaleh.