The document highlights the aspects relate to the requirements for the entities providing testing services, as well as the services in the sphere of laboratory testing, and also the ones proving quality assurance and radiology measurement services.
Table of Contents
Introduction
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 followed by the parties involved 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 and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding changes to the underlying regulations.
In particular, the scope of the guidance covers the requirements applicable to specific types of entities undertaking activities in the sphere of medical devices.
Testing Laboratories
According to the guidance, the main requirements to be fulfilled by testing services providers (laboratories) include, inter alia, the following ones:
- A manager should have a bachelor’s degree in the relevant field,
- An entity should provide detailed statements of approved tests, together with the information about the products subject to testing, to the authority,
- Employing an inclusive laboratory electronic system.
As further explained by the SFDA, the obligations of the said entities include:
- Obtaining the necessary accreditation from the Saudi Center for Accreditation with the relevant tests and products covered by its scope. The authority additionally emphasizes that the said accreditation should be obtained within one and a half years from the date the initial license has been granted.
- Providing the SFDA with organizational structure, a list of technical and administrative staff, a certified copy of their qualifications, training courses, their job descriptions, and identification of the devices and equipment needed to operate the laboratory within one and a half years from the date of obtaining the license.
- Should the expansion of the scope be requested – submitting additional information about the tests conducted and products covered to the authority. In such a case, new tests should also be covered by the scope of certification.
- Ensuring compliance with the applicable requirements in case of any third parties involved (outsourcing certain functions). Furthermore, it is also important to mention that such actions require prior approval to be granted by the authority (the latter will require the appropriate agreements to be shared).
- Should the increase in the number of tests be required – the details should be provided, together with certification.
- Committing that all tests are conducted according to the SFDA license and by the approved price.
- Issuing test results in line with the applicable regulatory requirements.
- Presenting the license, accreditation certificate, organizational structure, technical departments, and test prices in a visible place at the laboratory entrance, and not making any modifications without SFDA approval.
- Committing to conduct competency tests organized by SFDA.
- Preserving intellectual ownership of the standard used, maintaining the confidentiality of information accessed by [the entity or its employees] or those who have been contracted within the license period, even after the expiration of the license, and not disclosing any information related to the services without prior written consent from the SFDA.
- Applying for renewal of the license no later than 3 months prior to its expiration. The renewed license will become valid from the date of expiration of the current one.
Quality Assurance and Radiological Measurements
The document also outlines the requirements to be applied with respect to providers of services in the sphere of quality assurance and radiological measurements to healthcare institutions.
Specific requirements to be fulfilled by such institutions include, inter alia, the following ones:
- Appointing a Saudi radiation protection officer licensed by the Nuclear and Radiological Control Commission, and providing the SFDA with a copy of the radiation protection officer’s practice license.
- In case the entity is involved in operations with radioactive materials – the appropriate license is to be provided to the authority as well.
- Providing the SFDA with a copy of engineering plan for the radioactive sources storage area in the case that the establishment uses radioactive materials.
- Involving local experts with a bachelor’s degree in the relevant field.
- Ensuring compliance with the applicable standards in the sphere of measuring devices and simulators.
- Providing the authority with the organizational structure, and details on technical and administrative staff, together with the details on their qualifications and training completed.
- Providing SFDA with a copy of procedures and steps followed to implement each requested service to obtain a license, with an explanation of approved scientific reference for conducting tests method.
- Providing a certified copy of the radiation protection and safety program at the establishment in both Arabic and English, which describes the radiation protection system used and proposed emergency response plan in the case of an accidental radiation hazard, and radiation technical consultancy service providers are excluded.
The document further describes the obligations of the parties providing such services, namely:
- Ensuring compliance with the relevant instructions on radiation protection, including transportation of radioactive materials;
- Using the approved scientific references in the context of the reports;
- Reflecting the activity of the entity in the respective entry in the commercial register (once the license is granted by the SFDA);
- Refraining from using unlicensed radioactive sources, as well as selling, renting, or making available in any other way the radioactive sources;
- Performing the disposal of radioactive sources that are no longer supposed to be used strictly in accordance with the respective regulatory requirements.
- Duly notifying the authority in case of a failure in one of the radiology and medical imaging devices quality assurance tests, or in the case of a defect in radiology rooms shielding within 3 days of test results report issuance with attaching a copy of the report.
In summary, the present SFDA guidance describes in detail the regulatory requirements to be applied with respect to specific types of entities involved in operations with medical devices, namely the ones providing laboratory testing and radiology services. The document provides additional clarifications regarding the requirements such entities are subject to and also highlights the key points to be considered in terms of their obligations.
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