No, it is necessary to fill out the risk assessment form in the guideline.

Yes, by sending an email to:

icd@sfda.gov.sa

importation of used medical devices is not allowed

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

It is mandatory to respond to SFDA with the available justifications and procedures within the specified period, then the case and extension are evaluated according to the justifications and procedures presented.

yes

No 

Yes, manufacturer through its Authorized Representative (AR) or importer shall report to the SFDA any Field Safety Corrective Action when the KSA is affected within (2) working days from Field Safety Corrective Action issuance date by manufacturer

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.