May 31, 2020 16:31
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.
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.
It is not permitted to import cosmetic products unless the certificate of conformity states that the product complies with SASO standards.
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).
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.
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.
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.
- In Vitro Medical Devices.
- Non Medical Reagents and Indicators.
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: