The Saudi Food and Drug Authority (SFDA) of Saudi Arabia has published a guidance document dedicated to the rights and responsibilities of the authorized representatives of the foreign medical device manufacturers. The scope of the document covers both pre-license and post-license activities the authorized representatives shall carry out in accordance with the applicable rules and regulations.
The document is intended to provide additional clarifications and recommendations regarding the current regulatory framework for medical devices made by foreign manufacturers. The SFDA guidance also contains sample agreements between a manufacturer and its authorized representative, and also between an organization representing multiple legal manufacturers within a single company and an authorized representative. The document continues the row of guidance documents issued by the SFDA to cover certain specific issues related to the parties involved in operations with medical devices. In particular, it should be interpreted in connection with the SFDA guidance for medical device manufacturers published by the regulating authority before.
It is also important to mention that the present document is based on the rules set forth by the Medical Devices Interim Regulation.
General Pre-License Activities
The SFDA states that under the general rule, a foreign medical device manufacturer is obliged to appoint an authorized representative in order to be allowed to market its products in the Kingdom of Saudi Arabia. The regulation also provides that such an authorized representative may also perform the duties of an importer and/or distributor. The authority also mentions that in the case of placing medical devices belonging to multiple categories, the manufacturer is allowed to appoint separate representatives for each group.
According to the regulation, upon the appointment of the authorized representative, all further communications between the regulating authority and medical device manufacturer would be carried out through the authorized representative. The relationships between the medical device manufacturer and its authorized representative should be governed by the appropriate agreement (the SFDA also refers to a “mandate”) describing the rights and responsibilities of both parties hereof. In particular, the authorized representative shall be entitled to submit an application for medical device marketing authorization to the regulating authority on behalf of the foreign medical device manufacturer. The SFDA additionally emphasizes that such an application could be submitted only providing that there is an appropriate marketing authorization granted with regard to the medical device in question in a GHRF Founding Member jurisdiction.
As it was already mentioned in the guidance for the foreign medical device manufacturers, multiple medical device manufacturers could be represented by the same authorized representative, providing that all appropriate agreements are in place. The regulation also outlines the key points to be addressed in such an agreement.
In the case that the authorized representative of the medical device manufacturer also acts as its importer and distributor, the provisions of the appropriate SFDA guidance of medical device importers and distributors should be applied.
One of the most important functions of the authorized representative is the registration with the SFDA. In particular, each entity involved in operations with the medical devices shall duly apply for the registration with the SFDA, and also to maintain the accuracy and reliability of the information contained in the registry. For instance, an entity shall inform the regulating authority about any material changes that occurred no later than 10 calendar days starting from the date such changes took place.
Each entity registered with the SFDA should be also assigned with the appropriate national registry number.
In order to apply for the registration, the interested entity shall submit online the application containing the following information:
- The indication of a role of the applicant (e.g. domestic medical device manufacturer, authorized representative, importer, or distributor).
- Details of the applicant, including its name, address, and other contact details; as well as the details of the particular person in charge of the registration.
- An applicant that is an authorized representative shall also provide the information about the foreign medical device manufacturer it represents.
- An indication whether the information is being submitted for the first time, or constitutes an update to the information submitted before (in such a case, the appropriate national registry number should be also indicated).
- An indication of the submission date.
Thus, all authorized representatives should perform the registration via the Medical Devices National Registry portal and obtain a national registry number. The regulating authority reserves the right to check the validity of the information.
Applying for a License
In accordance with the regulation, an authorized representative should be duly licensed with the SFDA. Moreover, the number of licenses it holds should meet the number of foreign medical device representatives it represents.
As it was mentioned before, all activity of an authorized representative should be carried out in accordance with the appropriate agreement concluded with the foreign medical device manufacturer (a mandate).
The SFDA guidance also outlines the main responsibilities of the authorized representatives with regard to the functions they shall perform, including communications with the regulating authorities.
The document issued by the SFDA also describes certain aspects related to the post-licensing activities to be performed by the authorized representatives. In particular, the document addresses the matters related to applying for a Medical Device Marketing Authorisation (MDMA) which is required for all medical devices irrespectively of their class under the risk-based classification. In this regard, the regulating authority also refers to the appropriate Guidance on Marketing Authorization Procedures, which is dedicated to the application procedures documents to be submitted by the applicant.
According to the SFDA guidance, all information could be divided into two main categories:
- General information about the foreign medical device manufacturer, and
- Information specific to the Kingdom of Saudi Arabia, including the aspects related to the GHTF Founding Member jurisdiction the entity applying for an authorization refers to.
The regulating authority also mentions that it may require the foreign medical device manufacturer to provide additional information confirming the claims related to the safety and performance of the medical device subject to review. Such documentation could be also provided through the authorized representative duly appointed by the foreign medical device manufacturer as described herein.
The SFDA also emphasizes that in case the application covers several types of medical devices, the information submitted by the applicant should also cover all types of medical devices respectively.
Upon successful completion of the application review, the regulating authority would issue a Marketing Authorization Certificate confirming that the medical device in question could be marketed in Saudi Arabia. Such a certificate shall contain its own number, and also the indication of a Medical Device Listing National Registry Number.
Besides the responsibilities outlined hereinabove, the SFDA guidance for authorized representatives of foreign medical device manufacturers also covers some specific aspects related to the post-licensing activities, such as the ones related to advertising and marketing materials intended to be used in the course of promotional activities.
Summarizing the information provided here above, the present guidance addresses the most important matters related to the responsibilities of the authorized representatives and their functions. The document provides additional clarifications and references to the applicable regulations in order to assist foreign medical device manufacturers and other parties involved in operations with medical devices in achieving and sustaining compliance with the requirements set forth under the existing regulatory framework.
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