SFDA Guidance on Establishment Licensing: Conformity Assessment and Clinical Trial Verification

Table of Contents

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 requirements for licensing of medical devices establishments. The guidance provides additional clarifications regarding the requirements the parties involved in operations with medical devices are subject to, as well as recommendations to be considered in order to ensure compliance thereto. At the same time, it is important to mention that 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 amendments to the underlying regulations. 

The scope of the guidance covers, inter alia, the aspects related to the licensing requirements for establishments involved in clinical trial verification, as well as service providers of conformity assessment and quality management system. 

Establishments of Clinical Trial Verification

First of all, the guidance outlines specific requirements to be applied with respect to entities conducting clinical trial verification. According to the document, these requirements include:

1. To complete the electronic application available on the authority’s website;
2. To appoint a Clinical Trials Verification Establishments manager (full-time, Saudi national, having a bachelor’s degree in the related sphere);
3. To provide documentation related to the aforementioned responsible person (including CV and certificates confirming experience);
4. To appoint a person to be responsible for clinical trials (full-time, Saudi national, having a bachelor’s degree in the related sphere at minimum).

Apart from the requirements listed hereabove, the guidance also outlines the obligations to be fulfilled by the entities involved in the verification of clinical studies, namely:

1. No clinical trials without SFDA approval shall be verified;
2. Compliance with the requirements for clinical trials of medical devices published on SFDA’s website;
3. Proof of compliance to standard of Clinical investigation of medical devices or a similar version;
4. Proof of compliance to standard of In vitro diagnostic medical devices or a similar version;
5. Appointing a trained and qualified employee and organizing a continuous training programs to develop their skills;
6. Implementation of documented work procedures for the establishment;
7. Providing training programs for employees of the agency executing clinical trials that suitable to the conducted clinical trials. 

Service Providers of Conformity Assessment

The scope of the document also covers the aspects related to the regulatory requirements for service providers of conformity assessment and quality management system. As in case of other establishments, the authority starts with providing a list of specific requirements to be applied. According to the document, these entities should:

1. 1. Obtain the appropriate accreditation from the Saudi Accreditation Center. The authority additionally emphasizes the importance of ensuring the proper designation scope is included. In this respect, the authority refers to the respective regulation on conformity assessment bodies (CAB) and private laboratories, and also to the guidelines dedicated to these types of entities.
   2. Provide the authority with a conformity assessment program addressing specific requirements and procedures with respect to each of the spheres covered by the scope of the application.
   3. Provide the authority with the organizational structure chart, together with the list of personnel (both technical and administrative), the details on their qualification, and the training completed.
   4. Implement an electronic system ensuring all the procedures associated with issuing conformity certificates and reports are duly documented. The authority should also have full access to the said system. As further explained by the SFDA, the said system should include, inter alia, the following:

• The number of applications received … detailed by country of origin or source;

• Number of applications for which conformity certificates were granted, and SFDA may verify the certificates;

• Number of rejected applications;

• Number of applications for which corrective action was requested;

• Corrective actions completed and documented;

• Number of objections submitted by customers on verification results;

• Any specific reports or statistics requested by the SFDA. 

The document also describes in detail the obligations the parties involved in conformity assessment should fulfill. These obligations include:

1. 1. Being responsible for any and all claims associated with the activities undertaken;
   2. In case of the activities being partially outsourced – to ensure they are conducted strictly in accordance with the requirements set forth by the authority (the latter should be provided with the copies of the relevant agreements), while the license holder would still be responsible for all the activities;
   3. Complete a conformity assessment as follows:

• Inform the establishment of any non-conformities and required corrective actions, if any;

• Provide the SFDA with a conformity assessment report in accordance with the approved forms by the SFDA, within a maximum period of 15 days from the completion of the conformity assessment action;

• Conformity shall be checked periodically according to the risks assessment;

1. 1. Ensure the authority has access to the main resources of the entity;
   2. Follow the record-keeping requirements in terms of specialists participating in each process (including the ones taking place aboard), and also provide these records to the authority upon request;
   3. Develop and implement the procedures ensuring impartiality and integrity, establishing that:

• Employees shall not be involved in the design, manufacture, marketing, installation, maintenance, or supply of the medical device,

• Employees shall not have previously participated in providing consulting services related to medical devices,

• There shall be no financial interest with the manufacturer, importer, or distributor of the medical device; 

1. Develop and implement the documented procedures ensuring the safety and confidentiality of documentation received in the context of conformity assessment activities (the authority explicitly prohibits disclosure of such information without obtaining prior approval from the respective party);
2. Executing a service level agreement within the scope of designation.

In summary, the present SFDA guidance describes in detail the regulatory approach to be applied with respect to specific types of entities involved in operations with medical devices, namely the ones undertaking verification of clinical trials and conformity assessment. Their document outlines the specific requirements these entities will be subject to, and also highlights the key points regarding their obligations.

Sources:

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

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