SFDA Guidance for Overseas Manufacturers

Preparing for Medical Device Marketing Authorization in Saudi Arabia

The authority mentions that the current approach described in the present guidance is actually based on the Medical Devices Interim Regulation – one of the core country’s regulations in the sphere of medical devices. According to the aforementioned regulation, any foreign medical device manufacturer shall duly appoint an authorized representative in Saudi Arabia. Such a representative shall meet the following criteria:

• It should be duly appointed as a representative of a particular medical device manufacturer,
• A letter of authorization (mandate) should be issued in writing, outlining the particular activities the authorized representative is entitled to carry out on behalf of the foreign manufacturer, providing that the scope of such activities covers the corresponding responsibilities of the medical device manufacturer,
• The appropriate procedures have been implemented strictly in accordance with the applicable requirements. 

Moreover, an authorized representative should also have an establishment license to be issued by the country’s regulating authority for each foreign medical device manufacturer separately. At the same time, the foreign manufacturer may also appoint a separate representative with regard to each particular category of products to be marketed in Saudi Arabia. 

As it was already mentioned before, the sphere of responsibility of the authorized representative should be outlined in a written mandate to be issued by the foreign medical device manufacturer. In particular, the authorized representative shall be entitled to:

1. Carry out a representation of the foreign medical device manufacturer in all communications with the regulating authority.
2. Conduct a listing of all categories of medical devices to be marketed in Saudi Arabia. 
3. Have access to the appropriate application for marketing approval, and also to submit additional documentation required for the review of the application for medical device marketing approval.
4. Communicate with the regulating authority regarding the post-market surveillance and special preventive and corrective actions associated thereto. 
5. Provide the regulating authority with all the necessary information and documents related to the medical device.
6. Duly notify the regulating authority about any adverse events taking place in other countries where the same device is being marketed. In such a case, an authorized representative shall provide the SFDA with the exhaustive information regarding the matter, and also describe the actions performed by the foreign medical device manufacturer to address the issues associated thereto. 
7. Duly notify the regulating authority about any field corrective and preventive actions taken by the foreign medical device manufacturer in the course of post-market activities, including the grounds for such actions and description of the particular actions taken. 
8. Communicate with the distributors, integrators, and other parties involved in operations with medical devices marketed in Saudi Arabia. 

At the same time, the authority also states that the foreign medical device manufacturer is allowed to entitle its representative to carry out the activity other than outlined here above. 

Thus, the foreign medical device manufacturer itself does not require any additional registration or license, while both registration and license are required for its authorized representative which should be duly registered with the SFDA and hold the appropriate license.

Applying for Medical Device Marketing Authorization in Saudi Arabia

According to the general rule, a medical device could be allowed for marketing in Saudi Arabia only under the condition that the appropriate Medical Device Marketing Authorization (MDMA) has been issued by the regulating authority. The SFDA additionally emphasizes that from a regulatory standpoint, the accessories of medical devices should be construed as independent medical devices, consequently, they should be subject to authorization under the general rules. 

Another important point relates to the marketing approval to be granted in other countries – according to the SFDA guidance and Article 6 of the Medical Devices Interim Regulation, to obtain marketing authorization, medical devices shall comply with the relevant regulatory requirements applicable in one or more of the jurisdictions of Australia, Canada, Japan, the USA, and the EU/EFTA, and additionally with provisions specific to the KSA concerning labeling and conditions of supply and/or use. 

The SFDA states that the aforementioned marketing authorization is required for all medical devices irrespectively of their class under the risk-based classification, except in-house medical devices manufactured by healthcare institutions and intended solely for internal use.

In order to apply for a medical device marketing authorization, the foreign medical device manufacturer shall provide its authorized representative with all the information required to be submitted to the regulating authority. In particular, the authorized representative would have to fill in the appropriate application form available via the official website of the SFDA. The particular scope of the information to be provided in the course of the application for marketing approval outlined in the following regulations: 

• Implementing Rule MDS-IR6 Marketing Authorisation,
• The electronic application forms accessible via the website of the regulating authority,
• MDS-G5 Guidance on Marketing Authorization Procedures.

Activities After the Device Receives Marketing Authorization

Besides the preparation and submission stages, the SFDA guidance for foreign medical device manufacturers also covers some aspects related to the activities to be carried out by the manufacturers and their authorized representatives after obtaining the MDMA. In particular, the guidance describes the applicable regulations related to the following matters:

1. Advertising medical devices in Saudi Arabia. According to the applicable regulations, only the devices for which an MDMA has been granted are allowed for advertising. Moreover, all advertising materials should be subject to the prior approval by the regulating authority. Any materials used in the course of advertising and promotional activities should be reliable and accurate, and should not mislead the potential users of the medical device in question. The information provided therein should correspond to the particular audience such materials are addressed to (e.g. laypersons or healthcare professionals). The advertising materials should be also provided to the regulating authority when submitting the application for the MDMA. 
2. Language requirements. According to the applicable rules, the advertising and marketing information should be provided in English and, when necessary, in Arabic.

The authority also mentions that any further changes to the advertising materials should be subject to the SFDA`s approval. In accordance with the procedure outlined in the present SFDA guidance, upon receipt of the medical device marketing approval, the foreign medical device manufacturer shall contact the regulating authority asking for the explicit confirmation that the advertising and marketing materials submitted in the course of initial application are compliant with the applicable requirements and are approved by the regulating authority.

Summarizing the information provided here above, the SFDA guidance for foreign medical device manufacturers covers the most important aspects to be considered on all the steps, including preparation of the application, applying for the medical device marketing approval, and also the activities to be carried out upon receipt of such an approval. The document also describes the core responsibilities of the authorized representative to be appointed by the foreign manufacturer.

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Sources:

https://old.sfda.gov.sa/en/medicaldevices/regulations/DocLib/MDS-G4.pdf