The Saudi Food and Drug Authority (SFDA) of Saudi Arabia has published guidance for importers and distributors. The document is intended to provide additional clarifications regarding the applicable rules and requirements the parties involved in operations with medical devices shall follow.
The structure of the document replicates the similar documents addressed to the local and overseas medical devices manufacturers, and their authorized representatives published previously by the SFDA. From a legal standpoint, the guidelines are based on the Medical Devices Interim Regulation, and also on the Implementing Rule MDS-IR 2 Establishment Registration.
Pre-Licensing Activities of Importers & Distributors
The first section of the present SFDA guidance is dedicated to the important aspects to be considered by the medical device importers and distributors during the pre-license stage. According to the applicable regulations, the medical device importers and distributors shall register their establishments with the SFDA. At the same time, the local medical device manufacturer, as well as an authorized representative of the overseas medical device manufacturer, may act as the importer and/or distributor. Thus, the entity intended to supply medical devices and distribute them in the Kingdom of Saudi Arabia shall register with the SFDA. Moreover, upon registration, the entity is obliged to duly inform the regulating authority about any significant changes to the information kept in the entries of the register and sustain its validity. In particular, there is an obligation to notify the SFDA of any significant changes within 10 calendar days from the date such changes took place.
When applying for the registration, the applicant shall indicate its role (e.g. an importer or a distributor of medical devices), and also provide a detailed description of the activities it intends to carry out in Saudi Arabia. The information to be submitted by the applicant shall also include its name and contact details, as well as the address and contact details of its responsible person. Additionally, the applicant shall indicate whether the submitted application is a new one, or is intended to amend the existing entry. In the latter case, the applicant shall indicate the National Registry Number assigned during the initial registration and used by the regulating authority for further references.
Thus, in accordance with the applicable regulations, each importer and distributor shall be assigned with the appropriate Establishment National Registry Number prior to commencing its activity in the sphere of medical devices. The particular registration procedure is prescribed by the Implementing Rule MDS-IR2 Establishment Registration. The application shall be submitted in electronic form via the Medical Device National Registry (MDNR), the country’s national register. The regulating authority additionally emphasizes that the information to be submitted by the applicant shall be complete and accurate.
With regard to the matters related to registration, the SFDA outlines the following key points:
- In the case that an authorized representative actually carries out importation or distribution, it shall also comply with the requirements set forth for a medical device importer or distributor.
- In the case that a local medical device manufacturer markets its products in Saudi Arabia, it should be deemed as a distributor.
- The regulating authority may, from time to time, require the medical device importer or manufacturer to confirm whether the information recorded in the appropriate registry is relevant and complete.
When applying for the registration, the importer of the manufacturer shall also indicate the particular categories of medical devices it intends to supply, as well as the contact details for medical device manufacturers.
Medical Device Importer or Distributor: Establishment License
As it was already mentioned before, an establishment license is required for the entity to be allowed to carry out importation or distribution activities. In case if an entity intends to conduct both these activities, both should be indicated in the establishment license. In order to apply for an establishment license, the applicant shall submit the appropriate application in electronic form via the Medical Device Establishment Licensing (MDEL) service available on the official website of the regulating authority. Should the submitted application comply with any and all applicable requirements, the regulating authority would grant an establishment license subject to renewal on the annual basis. According to the present SFDA guidance, a licensed entity shall duly notify the regulating authority about significant changes to the information submitted in the course of the initial registration. In particular, the licensed entity shall notify about the changes to:
- Its contact information,
- The categories or groups of medical devices subject to importing or distribution,
- Representation of an additional medical device manufacturer.
The guidance also provides a list of obligations of the medical device importers and distributors initially introduced by the Medical Devices Interim Regulation. The obligations include the following ones:
- Notify the manufacturer/s of the device/s…, or his authorized representative/s, of his intention to place these devices on the market;
- Ensure that medical devices are stored and/or transported under conditions specified by the manufacturer;
- Ensure traceability of devices it supplies to the market and be involved in market surveillance of devices that have been put into service;
- Ensure the labeling accompanies each medical device together with a copy of the marketing authorization and undertake to inform the SFDA if they are unable to fulfill these obligations.
In order to assist medical device importers and distributors intended to place medical devices on Saudi Arabia`s market, the regulating authority also outlines the scope of the information to be provided by the entity applying for the establishment license. According to the guidance, and also the Implementing Rule MDS-IR4 Establishment Licensing the guidance refers to, the applicant intended to import medical devices shall submit the following information:
- Information about the foreign manufacturer of the medical devices the interested entity is going to place on the market, as well as the information about the authorized representative duly appointed by the foreign manufacturer.
- A confirmation stating that the aforementioned foreign medical device manufacturer was duly informed about the intent of the applicant entity to import its products into Saudi Arabia.
- A statement indicating that the applicant took all necessary steps to ensure the medical device manufacturer complies with any and all applicable requirements.
- Information about the categories the medical devices the applicant intends to import belong to.
In case if the applicant intends to distribute medical devices in Saudi Arabia, the statement indicating that the applicant took all necessary steps to ensure the medical device manufacturer complies with any and all applicable requirements is not required, while the indication of medical devices to be distributed could refer either to the category or generic device group.
Another important aspect to be mentioned relates to transportation requirements. In accordance with the present SFDA guidance, the applicant for the establishment license in the sphere of importation of medical devices shall provide the description of the procedure the applicant will follow to comply with the manufacturer`s requirements for the storage, handling, and transport of medical devices it imports, and an attestation that it will implement and maintain this procedure.
Summarizing the information provided here above, the SFDA guidance for medical device importers and distributors outlines the core responsibilities of the entities intended to import into or distribute medical devices in Saudi Arabia. In particular, the document describes in detail the application procedure the interested party shall follow in order to obtain an establishment license.
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