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For information about the technical documentation required to obtain TFA Marketing Permissions , please refer to MDS-G5- Guidance on Requirements for Medical Device Listing and Marketing Authorization:
https://sfda.gov.sa/sites/default/files/2020-09/MDS-G5.pdf

Please check the following link: https://www.sfda.gov.sa/ar/list_countries_products 

Currently the Halal slaughter certificate Certification is mandatory for the shipments of meat, poultry and their products coming to Kingdom of Saudi Arabia and issued by exporters and appointed by the center.

Refer to SFDA requirements in this regard, as well as the following procedural rules and guidelines: • Implementing Rule for licensing facilities (MDS-IR4) https://www.sfda.gov.sa/en/medicaldevices/regulations/Pages/implementing_rules.aspx • Post-Marketing Control Implementing Rule (MDS-IR7) https://www.sfda.gov.sa/en/medicaldevices/regulations/Pages/implementing_rules.aspx • Relevant Guidance

Only, the radioactive materials that are licensed to a health facility in a practice license.

 

Medical Device clearance conditions and requirements are published at: (Click here)

 

 

- Raw feed :

Ingredients :  It contains only one substance and has specific and authorized lists that can be referenced through Saudi Standard No. SFDA.FD.41 in addition to the lists of raw feed in the Feed Products Registration Guide

Method of use : It is allow using directly in the field

- Feed additives

Ingredients :  It contains only one substance and has specific and authorized lists that can be referenced through Saudi Standard No. SFDA.FD.41 in addition to the lists of raw feed in the Feed Products Registration Guide

Method of use : It is allow using directly in the field ، It is allow using in factories

- Premix

Ingredients :   It contains more than one of the allowed feed additives, or it may be a mixture of the allowed feed additives and raw feed

Method of use :  It is allow using directly in the field if it is mixed with water or fodder, if the method of use is applicable, especially for mixtures destined for traditional breeding animals (camels - sheep - goats) in order to ensure that the product is use in a correct manner, It is allow using in factories

- Compound feed

Ingredients :  Contains a mixture of permitted feed additives and raw feed

Method of use :  Provides animal directly without mixing with water or feed

The importation and clearance requirement is being updated and it will be published soon.

You can reach to fees of marketing authorization application via:
https://sfda.gov.sa/sites/default/files/2019-10/Fees-Rev-Times-Mark-Aut-App-ar%2Cen_9.pdf
the marketing authorization will be issued during 35 business days as maximum if all requirements are fulfilled.



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