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I would like to importer products but I am not entirely certain whether it is considered cosmetic product or medicine?

It can be ensured that the product to be imported are cosmetic products by implementing the definition of cosmetic products of SASO 1953 (Cosmetic Products – The Cosmetic Product (Safety) Regulations), and it is possible to apply to SFDA to classify whether it requires registration as medicine or not.

I wish to ensure compliance of the product’s label to what is approved by SFDA?

Compliance of the product label can be ensured by implementing the requirements of SASO 1953 (Cosmetic Products – The Cosmetic Product (Safety) Regulations), this and other cosmetic products related standards can be obtained from SASO website at the moment, and in the future from the SFDA website.

Is it possible to import products accompanied by certificate for standards other than standards issued by SASO?

It is not permitted to import cosmetic products unless the certificate of conformity states that the product complies with SASO standards.

What are the conditions related to certificates of conformity?

The certificate of conformity shall be issued by an accredited certification company at the country of origin and shall be attested, and the certificate shall state that the product complies with Saudi standards issued by the Saudi Standards, Metrology and Quality Organization (SASO).

Is there a list of the companies approved to issue certificates of conformity?

Currently there is no list; and soon SFDA will make agreements with some companies for issuing certificates of conformity for imported cosmetic products, and will be announced duly after approval.

Is it mandatory to register cosmetic products at SFDA before import?

At the moment it is not mandatory to register cosmetic products before import, and SFDA is currently building up an electronic system for registration and eventually it will a condition for import, and will be announced once completed on our website.

Does the manufacturer need to notify SFDA about all of the reportable and not reportable adverse events?

Manufacturer is required to notify SFDA/NCMDR of all reportable adverse events only .

For more information please refer to the SFDA-Medical Devices Sector websitehttp://www.sfda.gov.sa/en/medicaldevices/Pages/default.aspx

  What should the manufacturer do if the recalled device owner refuses to cooperate with the correction plan?

 

The establishment by itself or through its authorized representative is responsible for  communication with healthcare facility  in order to execute the recommended corrective action and shall take all the necessary measure , such refusal shall not waived the responsibility be all means.

What are the items that needs to have temperature indicators?

- In Vitro Medical Devices.

- Non Medical Reagents and Indicators.

what are the designated ports of Entries for Medical Devices?

Out of twenty seven ports of entries in the kingdom of Saudi Arabia, Medical Devices sector is currently located in nine ports only. The ports are listed as follows:

ports

 

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