SFDA Guidance on Establishment Licensing: Overview

The document highlights the key points associated with the licensing requirements for medical device establishments.

The Saudi Food and Drug Authority (SFDA), a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the requirements for licensing of medical device establishments. The document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding changes to the underlying regulations.

Recommendations provided in the guidance are applicable to medical device manufacturers, their authorised representatives, as well as other parties involved in operations with medical devices, such as importers, distributors, optical establishments, warehouses, establishments of clinical trials verification, and various service providers. At the same time, the authority explicitly states that these recommendations do not apply to pharmacies, laboratories, and partial sale establishments, even though these entities are anyway obliged to comply with the requirements set forth under the Medical Devices Law and the relevant Executive Regulation.

Regulatory Background

As it was mentioned before, the existing regulatory framework for medical devices is based on the Medical Devices Law. With respect to the establishment licensing, the said law provides that an establishment shall not engage in any of the activities subject to this Law unless registered and a license is obtained; while it is also stated that the Regulations shall specify the conditions and procedures necessary for registration; issuance of the marketing authorization; and for license issuance, renewal, amendment, transfer, and revocation. Similar approach is shared by the Medical Devices Executive Regulation which provides that establishments that practice any aspect of the activities subject to the provision of the Law and its Regulation shall obtain a license for the establishment itself, its branches, and its warehouses by the SFDA in accordance with the conditions and requirements mentioned in this regulation.

Responsibilities and Authorities of SFDA

First of all, the document outlines the authorities and responsibilities of the regulatory agency. According to the guidance, they include, inter alia, the following ones:

To examine the application submitted by an interested party in order to verify the accuracy and completeness of the information provided, and also whether it is sufficient to verify compliance of the product in question with the applicable regulatory requirements;
To conduct inspections of the entities involved in operations with medical devices in order to verify continued compliance with the requirements they are subject to;
To notify the interested parties of the information received;
To ensure the confidentiality of the information provided in the course of the licensing process;
To determine the fees payable by the interested parties for the licenses issued;
To reject the applications that do not meet the applicable regulatory requirements;
To perform supervision activities, including inspections;
To take regulatory actions in case of non-compliance and violations identified;
To conduct investigations with respect to complaints received;
To publish and maintain the list of the license holders authorized to conduct operations with medical devices.

General Licensing Requirements

In order to assist interested parties in their preparation for filing an application, the document also provides an overview of the applicable licensing requirements.

According to the guidance, the list of general requirements includes, inter alia, the following ones:

To comply with any and all applicable regulatory requirements before submitting an application, and also to demonstrate compliance thereto;
To have a legal entity being responsible for the operations;
In case of medical device manufacturers, importers, and distributors (categories A and B) – to obtain a Quality Management System (QMS) certificate to be issued by a Conformity Assessment Body (CAB) accredited by the authority, confirming compliance with the relevant Saudi Standards;
In case of authorized representatives, importers, and distributors (categories C and D) – to submit the evidence of proper implementation of the QMS, as well as the appropriate inspection report issued by the authority;
To comply with any and all rules and regulations the authority may issue from time to time;
To set up an account in “GHAD” – an online system used for interactions with the authority;
To use the abovementioned online system to submit an application and documents associated thereto;
To pay the license fees;
To keep the documentation related to the activities undertaken for the period not less than five years;
To abstain from any activities conducted with medical devices that are not yet registered by the authority;
If requested by the authority – to provide any information or documents within 10 days;
To have human resources necessary to conduct operations;
To develop and implement a documented procedure describing the storage and transportation of medical devices;
To have all the marketing materials approved by the authority before being used;
To provide inspectors with access to any documents or information they will require;
To notify the authority about any changes to the information submitted in the course of the initial registration process no later than 10 days from the date such changes take place;
To comply with any and all applicable post-marketing requirements;
To notify the authority without undue delay in case the entity cannot ensure further compliance with the applicable requirements;
To inform the authority about non-compliant medical devices;
To apply for renewal of the license 60 days prior to its expiration;
To apply for amendments to the license using the aforementioned online submission system.

In summary, the present SFDA guidance provides general information about the regulatory framework for establishment licensing and also outlines the general requirements for the entities conducting operations with medical devices. The document also describes the authorities and responsibilities of SFDA as a regulatory agency.

Sources:

https://sfda.gov.sa/sites/default/files/2023-03/RequirementsLicensingMDEstablishments_0.pdf

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