Temporary Importation and Clearance
Requirements for Imaging/Radioactive
Products
Executive Administration for
Radiation Protection and Safety
Medical Devices Sector
MDS-R-510-001 – V2
Page 1 of 4
Temporary Importation and Clearance Requirements for
Imaging/Radioactive Products
Effective Date: 10/06/1434
‫ الرجاء الرجوع إىل البوابة الداخلية للقطاع للحصول على النسخة النهائية املعتندة‬,‫الوثائق املطبوعة غري مراقبة‬
GENEARL INSTRUCTIONS
1.
Importers of imaging products (X-ray and CT imaging drugs, MRI imaging drugs, Ultrasound
imaging drugs, Nuclear imaging drugs (radiopharmaceuticals) and Other emerging imaging drugs) and
radioactive materials are required to satisfy/complete all sections: A, B, C and D.
2.
Importers of imaging/radioactive products are required to complete/submit the special
application for imaging/radioactive products importation and clearance form (MDS-F-510001-V2).
A. REGISTRATION
Based on (Chapter Four, Article Ten, Medical Device Interim Regulation) all importers should:
1.
Register their establishments with the Saudi Food and Drug Authority (SFDA) Medical Device
National Registry (MDNR).
2.
List their products with the MDNR.
B. GENERAL DOCUMENTS
Importers are required to adhere to/provide all the following:
1.
Copy of SFDA Medical Device Establishment License (MDEL). Refer to (Chapter Five,
Article Fifteen, Medical Device Interim Regulation).
2.
Copy of the Bill of Landing (BOL) or the Air Waybill (AWB).
3.
Copy of the Commercial Registration (CR).
4.
Manufacturer’s stamped original invoice that includes:
- Shipment description (name of each item).
- Quantity of each item in the shipment.
- Unit weight of each item and gross weight of each package.
- Unit price of each item in the shipment.
- Production and expiration date.
- Batch/ Lot Number.
- Radioactivity (MBq), if applicable.
5.
Original Certificate of Origin stamped by the responsible party for commerce in the country of
origin.
MDS-R-510-001 – V2
Page 2 of 4
Temporary Importation and Clearance Requirements for
Imaging/Radioactive Products
Effective Date: 10/06/1434
‫مراقبة الرجاء الرجوع إىل البوابة الداخلية للقطاع للحصول على النسخة النهائية املعتندة‬
, ‫الوثائق املطبوعة غري‬
6.
Enough proof that the products comply with the relevant regulatory requirements applicable in
one or more of the jurisdictions of Australia, Canada, Japan, the USA and the EU/EFTA, and
additionally with provisions specific to the KSA concerning labeling and conditions of supply
and/or use. (Chapter Two, Article Six, Medical Device Interim Regulation).
7.
‫‏‬
Copy of original manufacture’s Quality Management System (QMS) as well as Good
Manufacturing Practice (GMP) certificate.
8.
Copy of the purchase order (PO) from the customer.
9.
Official letter that proves that the products are sold in the country of origin.
10. The Requirements for The Storage, Handling and Transport of Medical Devices published in
2010 by the SFDA are met so that the package design takes into account ambient temperatures
and pressures that are likely to be encountered in routine conditions of transport.
11. Complete and submit the special application for imaging/radioactive products importation and
clearance form (MDS-F-510-001-V2).
C. SPECIAL DOCUMENTS
If any shipment contains radioactive materials, importers are required to adhere to/provide all the
following:
1.
Copy of the safe radioactive material transport documents.
2.
Copy of the Radiation Safety Officer (RSO) Certificate.
3.
Copy of the radiation safety program/measures.
4.
Indicate clearly where the radioactive products shipment will be stored after clearance.
5.
Ensure the correct packaging and that sufficient labeling accompanies each radioactive product
according to the updated international provisions of the International Atomic Energy Agency
(IAEA).
6.
Ensure that the dose limits and design requirements of the IAEA for this type of packaging are
satisfied and copies of each applicable certificate applying to the design have been submitted to
the SFDA.
7.
Indication of the maximum activity of the radioactive contents during transport and that the
package does not contain activity in excess of the values prescribed by the IAEA for the given
type of packaging.
MDS-R-510-001 – V2
Page 3 of 4
Temporary Importation and Clearance Requirements for
Imaging/Radioactive Products
Effective Date: 10/06/1434
‫مراقبة الرجاء الرجوع إىل البوابة الداخلية للقطاع للحصول على النسخة النهائية املعتندة‬
, ‫الوثائق املطبوعة غري‬
8.
The UN number assigned to the material as specified by the IAEA, preceded by the letters
“UN”, is legibly and durably marked on the outside of the packaging.
9.
The packages are marked with an identification of either the consignor or consignee, or both.
10. Statements regarding actions, if any, that are required to be taken are available to the national
carrier. The statement shall be in Arabic, English and any languages deemed necessary by the
carrier and shall include at least the following points:
a. Supplementary requirements for loading, stowage, carriage, handling and unloading of the
package, over pack or freight container, including any special stowage provisions for the
safe dissipation of heat, or a statement that no such requirements are necessary;
b. Restrictions on the mode of transport or conveyance and any necessary routing instructions;
and
c. Emergency arrangements appropriate to the consignment.
D. ATTESTATION
The importer should attest in the MDS-F-510-001-V2 form that he/she confirms the following:
1. All items listed in the invoice conform to the international provisions and standards as well as to
the requirements of SFDA Medical Devices Interim Regulation.
2. Adherence to the manufacturer transport and storage recommendation and that the place where
the shipment will be stored after clearance is certified and described.
3. The shipment does not contain: narcotics, explosives or any other prohibited substances as
described by the Ministry of Interior.
4. The shipment not to be handed to unapproved user(s).
5. Indication that the shipment contains or does not contain radioactive materials.
MDS-R-510-001 – V2
Page 4 of 4
Temporary Importation and Clearance Requirements for
Imaging/Radioactive Products
Effective Date: 10/06/1434
‫مراقبة الرجاء الرجوع إىل البوابة الداخلية للقطاع للحصول على النسخة النهائية املعتندة‬
, ‫الوثائق املطبوعة غري‬