The Saudi Food and Drug Authority (SFDA) of Saudi Arabia has published the guidelines on import and clearance requirements for particle accelerators used in radioisotope formation for medical application. The present document constitutes a second version of the guidance, providing healthcare institutions, importers, distributors, and other parties involved with additional clarifications and recommendations regarding the applicable requirements associated with particle accelerators.

Regulatory Background 

The present guidelines are based on “The Law of Saudi Food and Drug Authority” pursuant to which the SFDA is entitled to perform its activities in the sphere of medical devices regulation to ensure the safety and performance of medical devices allowed to be placed on the market. In particular, the SFDA has a right to develop and publish guidelines highlighting the most important aspects related to the requirements for various types of medical devices. The present SFDA guidance addresses the matters related to the particle accelerators used in radioisotope formation for medical application. 

SFDA Requirements for Particle Accelerators: Key Points 

As it was already mentioned before, the guidelines published by the Saudi Food and Drug Authority describe in detail the requirements to be applied in the context of importing and clearance of particle accelerators intend to be used in the healthcare sphere. 

First of all, the SFDA states that particle accelerators used in radioisotope formation for medical application could be imported in the Kingdom of Saudi Arabia only providing the appropriate permit has been granted by the regulating authority. In order to obtain the aforementioned permit, the applicant shall demonstrate compliance with any and all applicable requirements.

In order to meet the eligibility criteria, the applicant shall:

  • Create an account in the special system for electronic submissions – GHAD (the SFDA`s Unified Electronic System), and
  • Have a valid Medical Device Establishment License (MDEL), proving that the scope of such a license covers the activities in the sphere of importing medical devices. The license should be issued by the SFDA. 

With regard to the particular medical device in question, the applicant shall also obtain a medical device & product marketing authorization (MDMA). 

When carrying out the clearance at ports of entry, the applicant shall submit the manufacturer invoice and follow other requirements highlighted in the SFDA Guidance on Requirements of Shipment Clearance at Ports of Entry. The authority additionally emphasizes that the medical devices should have the appropriate packaging, providing that each package should be identified and associated either with the consignee, or the recipient, or both. 

The procedures for transporting medical devices should be compliant with the applicable regulatory requirements described in the appropriate SFDA guidance which is also available in Arabic on the official website of the authority.

SFDA Importation Permit: Application Process

In order to apply for the importation permit for the particle accelerators used in radioisotope formation for medical application, the applicant shall file the appropriate request via the aforementioned online submission system. The application should be accompanied by the documents required in accordance with the current regulations. 

This SFDA guidance also contains a list of documents to be included in the submission by the applicant, namely:

  1. A copy of the appropriate Medical Device Establishment License issued by the regulating authority. The scope of the license shall cover the importation or distribution of medical devices. It is also important to mention that this requirement is mandatory only for importers and exporters, while the healthcare institutions are not required to hold such a license.
  2. A copy of the medical device & product marketing authorization for imaging material (only in case the imaging materials are falling within the scope of medical device definition under the classification rules). 
  3. A copy of the radiation practice license of the receiving facility. Such a license should be issued by King Abdullah City for Atomic Energy or Nuclear & Radiological Regulatory Commission. 
  4. A copy of the appropriate license of the radiation safety officer as a key person of the receiving facility,
  5. A letter from the Ministry of Interior containing the request to the Saudi Food and Drug Authority to provide a response with regard to the importing of the particle accelerator. 
  6. The bill of lading. 
  7. A copy of the invoice issued by the manufacturer. Such an invoice shall contain the following information: names of the products (including both marketing and scientific ones), the number of products (items) shipped, the indication of the weight of each item and package in general, the price per item (or the price of each item, if differs), the manufacturing date and the date of expiration, the indication of a batch/lot number.
  8. The certificate of origin. This document should be stamped by the trade reference in the country of origin. 
  9. A statement that the shipment complies with the applicable requirements for medical devices. For instance, the applicant shall provide copies of the certificates demonstrating compliance with the applicable standards with regard to technical safety. 
  10. A copy of the Quality Management System (QMS) certificate of the manufacture, together with the Good Manufacturing Practice (GMP) certificate. 
  11. A purchase order issued by the receiving facility. 
  12. An official confirmation (e.g. a Free Sale Certificate) confirming that the product in question is allowed to be marketed in the country of origin. 
  13. The survey report of the radiation levels. Such a survey should demonstrate that the radiation level does not exceed the threshold prescribed under the applicable national and international rules and regulations. 
  14. Letter by supplier company to prove the approval for installation place.
  15. The appropriate application form. As it was mentioned before, the application form for importing particle accelerators used in radioisotope formation for medical applications should be filed electronically and served on the letterhead of the applicant.
  16. The copies of the approved technical specifications of the radiation-emitting device in question, describing its design and core elements and components. 
  17. The copies of technical drawings of the device`s core elements and components. In particular, such drawings should contain information about the location of the radiation-emitting source, as well as shielding and additional measures implemented by the manufacturer to ensure safety. In this section, the applicant shall also provide information about the components of the device, and also the materials used. 
  18. References to the applicable technical and safety standards. In this section, the applicant shall provide the references to the relevant standards, and describe in detail how the conformity with these standards could be confirmed. 
  19. Design validation and risk assessment records.
  20. A description of the radiation shielding.
  21. Information on the radiation leakages.
  22. The specifications for the accelerator beam target.
  23. Indications of the radiation output.
  24. Information on the physical size of the device in question.
  25. The samples of labeling, safety marking, and instructions for use. 
  26. A description of the external safety devices implemented. 
  27. The instructions for packaging and transportation. 
  28. The instructions for handling, storing, using, and operating the device subject to review. 
  29. Indications on inspection, servicing, and disposal. 
  30. The list of all radioactive sources and produces the device contains. 

Summarizing the information provided here above, the present SFDA guidance describes the most important requirements for importing and clearance of particle accelerators used in radioisotope generation for medical applications. In particular, the guidelines contain the list of documents to be submitted by the applicant in order to obtain an importation permit.

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Sources:

https://beta.sfda.gov.sa/sites/default/files/2020-11/ParticleAcceleratorsE.pdf


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