I wish to ensure compliance of the product’s label to what is approved by SFDA?
2022-02-05 17:32:20
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.
what does ,ean innovative medical device ?
2020-10-21 21:28:27
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
What are the conditions related to certificates of conformity?
2020-10-21 21:22:32
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).
