FAQ
FAQ
what does ,ean innovative medical device
A medical device may be designated as an Innovative Medical Device if it has an innovative feature in the technology, indications of use, or performance specifications that have no equivalence in the market. Furthermore, it is in the best interest of the patients, and at least one of the following criteria is met:
• the device provides considerable clinical advantages over an existing SFDA approved technology; OR
• the device provides considerable clinical advantages over an existing approved alternative treatment; OR
• there are no SFDA approved alternative technologies nor treatments available to patients
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.