The Saudi Food & Drug Authority (SFDA), the country’s agency responsible for regulations in the sphere of medical devices, has published a second version of its guidance on approval requirements for medical device advertising.
The current version of the document was issued in June 2021. The document is intended to provide additional clarifications and recommendations regarding the applicable regulatory requirements and the particular steps one shall follow in order to get medical devices advertising approved for use in Saudi Arabia.
The scope of the guidance covers any and all medical devices allowed to be marketed and used in the country. The recommendations provided in the document should be considered by both local and foreign medical device manufacturers, their authorized representatives, as well as distributors, importers, and healthcare institutions importing medical devices in order to meet their own needs.
According to the Law of Saudi Food and Drug Authority, the agency is entitled to carry out the appropriate functions with regard to advertising activities related to medical devices. The document further describes the way such activities should be performed.
Medical Devices Advertising: General Approach
According to the document, any advertising materials intended to be used to promote medical devices are subject to prior approval of the regulating authority. It is explicitly stated that such materials should be approved by the SFDA before the interested party will make them available to the general public or healthcare professionals (depending on the target audience of the advertisement). The particular medical devices described in the advertising materials should be duly registered in accordance with the regulatory requirements and procedures applicable for the particular type and class of medical devices under the country’s risk-based classification. The information contained in advertising materials should not be in any way misleading in terms of how the device operates. Moreover, it is prohibited to make claims that are not approved by the regulating authority.
If an importer or a distributor are going to develop advertising materials on their own, they will be required to obtain:
- An establishment National Registry Number/ an establishment account in GHAD;
- Medical Devices Establishment Licensing (The healthcare providers who import medical devices are not required to have it).
According to the document, the advertising materials used to promote medical devices in Saudi Arabia should include the following information and elements:
- The name of the medical device/supply,
- The name and address of manufacturer,
- MDMA certificate number (required in case the advertising approval was part of MDMA procedure),
- The advertising approval number (it is required in case of separate approval).
It is important to mention that the regulating authority explicitly prohibits any use of its logo in advertising materials as this could mislead the customers. Furthermore, the advertisement shall not indicate the establishment National Registry Number or its account in GHAD. It is also prohibited to include comparisons with similar products manufactured by other entities or make negative statements against competing products.
Under the existing regulations, the entity responsible for a medical device is also allowed to engage a third-party provider (advertising agency) to apply for approval. In such a case, an authorizing document should be certified by the Chamber of Commerce.
Should the responsible party decide to modify the advertising materials already approved by the SFDA, a new request for approval should be submitted, except in the cases when the party changes only the display medium, provided that the content of an advertisement remains intact.
Apart from the special requirements for medical devices, the advertising materials used to promote healthcare products should also comply with the general regulations on advertising, such as the Law of Printed Materials and Publications.
Responsibilities of Manufacturers and Authorized Representatives
The document outlines the scope of responsibilities of local medical device manufacturers and authorized representatives of the foreign ones. In particular, they should use only the materials approved by the regulating authority, and such approval should be obtained in advance, before using such materials in any way. Additionally, they should provide other parties engaged in the marketing of medical devices (e.g., importers and distributors) with all the approved advertising materials, specify the particular target audience, which could be either “Consumers” or “Healthcare practitioners” depending on the intended use of a medical device, and also specify the display medium to be used.
Responsibilities of the Applicant
The present FDA guidance also describes the responsibilities of the parties applying for approval for the advertising materials intended to be used to promote medical devices. According to the document, their responsibilities include the following:
- To ensure compliance with the applicable regulatory requirements set forth by the relevant legislation, including but not limited to the Medical Devices Interim Regulation,
- Issue advertising materials only after obtaining approval from the regulating authority,
- Cease the use of advertising materials upon expiration of the approval,
- Indicate the approval number related to advertising materials (except the cases when the advertising materials in question have been approved together with the medical device itself under the same application),
- Once the approval has been obtained – abstain from further modifications to the advertising materials. Otherwise, a new approval would be required (the scope of modifications requiring new approval includes translations as well),
- Cease the promotion of medical devices if new information becomes available that creates reasonable concerns about the safety and performance of the medical device in question, or if it is requested by the regulating authority,
- Be liable for providing misleading information regarding the device.
Specific Requirements for Advertising Materials Directed to Healthcare Practitioners
As mentioned, in certain cases, medical devices could be intended to be used only by healthcare professionals. Thus, such devices should be promoted only to the appropriate target audience, and special requirements should be applied as well. According to the document, the promotion of medical devices directed to healthcare professionals should meet the applicable regulatory requirements specified therein.
The language used should be English. It is allowed to supplement English text with the text in Arabic, but the content of both texts should be the same.
According to the document, there are two cases when a submission for approval of advertising materials is required:
- In the course of applying for a Medical Device Marketing Authorization (this approach applies in the case of advertising materials developed by the medical device manufacturer or its authorized representative).
- Applying for a separate approval for the advertisement of medical devices. In such a case, the application submitted by the interested party should be comprised of the following elements: an official letter written in Arabic, stamped by the company and addressed to the SFDA; a proof of medical device registration with the SFDA; an approval form for advertising material directed; a copy of advertising material; documents supporting claims.
In summary, the present SFDA guidance describes in detail the regulatory requirements the advertising materials for medical devices should meet in order to be approved for use in Saudi Arabia. The document highlights the most important aspects to be considered by the medical device manufacturers and other parties involved in the marketing and promotion of medical devices.
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