The Saudi Food and Drug Administration (SFDA), the country’s regulating authority in the sphere of healthcare products, has published updated guidance on approval requirements for medical device advertising.
The document is intended to provide additional clarifications regarding regulatory requirements related to advertising for medical devices, as well as the appropriate regulatory procedures to be followed in order to get approval for such advertising.
The scope of the guidance covers all parties engaged in operations with medical devices, namely:
- Local Medical Device Manufacturers,
- Authorized Representatives of Medical Device Manufacturers,
- Medical Devices Distributors,
- Medical Devices Importers,
- Healthcare Providers importing Medical Devices.
According to the current legislation, any and all advertising materials related to medical devices intended to be used in Saudi Arabia are subject to prior approval by the regulating authority. This requirement applies to advertising materials related to both medical devices for the general public and professional use. Moreover, as a precondition, the medical device itself should be registered in the SFDA and approved for marketing and use in the country.
The applicable regulations prescribe that information contained in advertising materials should be accurate and reliable and should not be misleading in terms of the effectiveness of the medical device when used for the intended purpose indicated by the medical device manufacturer. Additionally, it is explicitly prohibited to add claims other than approved by the regulating authority. All new claims regarding the medical device, its performance, and effectiveness should be justified and approved by the SFDA.
Before applying for approval for advertising materials used to promote a medical device in Saudi Arabia, the interested party shall 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).
Requirements for Advertising Materials
The present SFDA guidance also outlines the scope of information advertising materials should contain in order to meet the applicable regulatory requirements. According to the document, the advertising material shall contain the following information:
- The name of the medical device itself,
- Details about the medical device manufacturer, including its name and address,
- Number of the Medical Device Marketing Authorization (MDMA) certificate number, and
- The approval number for the advertising.
The authority emphasizes that its logo should not be used for advertising purposes. Additionally, the manufacturer shall not indicate the establishment National Registry Number or establishment account in GHAD.
It is also important to mention that the medical device manufacturer is allowed to authorize a third-party advertising agency to submit an application to the SFDA with regard to the approval of advertising materials to be used to promote its products. The appropriate authorization letter should be certified by the Chamber of Commerce.
Apart from the special regulations related to advertising for medical devices, the advertising materials an interested party intends to use should also comply with the provisions of the “Law of Printed Materials and Publications.”
The list of prohibitions also includes negative statements against competing products or any comparison with them.
The parties responsible for medical devices should ensure that individuals contacting the customers and promoting the products possess the necessary information regarding the products to communicate it accurately to customers once requested.
Apart from the main points of the current regulatory approach, the present SFDA guidance also outlines some important aspects to be considered by medical device manufacturers and other parties involved in the promotion and marketing of medical devices in Saudi Arabia. These clarifications include, inter alia, the following:
- Should the responsible entity need to make changes to advertising materials already approved by the SFDA, or commit a renewal, a new request for approval should be submitted to the regulating authority.
- If the interested entity is going to carry out a seminar dedicated to a medical device, the appropriate application for approval should be submitted to the regulating authority at least 20 days prior to the commencement date. Once the approval has been granted, the applicant will be allowed to carry out similar seminars during one year, provided that no changes to the content and format of the seminar will take place.
- Should the responsible entity decided to change the display medium for the advertising materials, no additional approval is needed, provided that the content and format of the advertisement remain intact.
The authority also clarifies how the applicable fees should be paid:
- If the application for approval covers a medical device with the accessories thereto, such application could be treated as an application for a single advertisement.
- If an accessory is to be promoted separately, such an application will require the payment of a separate fee.
- Should the application cover several medical devices, an application fee should be paid for each device separately.
According to the document, the sphere of responsibility of domestic medical device manufacturers and authorized representatives of foreign medical device manufacturers includes the following aspects:
- Ensuring all the advertising materials (either newly prepared material or revised versions of the material submitted was part of MDMA procedure) are approved by the SFDA before they are used by them or by importers or distributors.
- Providing importers and distributors (if applicable) a copy of all approved advertising materials and specify the following:
- Target audience: “Consumers” or “Healthcare practitioners”.
- Display medium such as (newspapers, magazines, TVs, Radio, Internet), social media (YouTube, Twitter, Facebook, Instagram, Snapchat) and others.
Responsibilities of the Applicant
The present guidance also outlines the responsibilities of the entity applying for approval of the advertising materials to be used to promote medical devices in Saudi Arabia. According to the current legislation, the applicants are responsible for:
- Ensuring compliance with any and all applicable laws and regulations, including but not limited to the Medical Devices Interim Regulation,
- Abstaining from using any advertising materials before they have been duly approved by the regulating authority,
- Ceasing the use of advertising materials after the expiration date of the respective approval,
- Indicating the approval number of the medical device, except in cases when an application for approval of advertising materials is submitted as a part of the initial Medical Device Marketing Authorization application,
- Abstaining from making any changes to the advertising materials that have already been approved by the SFDA,
- Applying for a new approval in case of any changes made,
- Suspension of promotion if new information received identifies risks associated with the medical device in question,
- Informing the authorized representative and the manufacturer about the request related to a medical device,
- Being responsible for any consequences arising from the provision of incorrect information in advertising materials.
In summary, the present SFDA guidance provides additional clarifications regarding the requirements advertising materials should meet. The document also describes the most important aspects to be considered when applying for the approval of advertising materials.
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