For more information, visit the SFDA medical device sector websitewww.sfda.gov.sa/en/medicaldevices/Pages/default.aspx All foreign manufacturers must appoint an authorized KSA (AR) representative. This AR assumes all the tasks provided by the transitional arrangements on behalf of the manufacturer and represents them with the SFDA. One of these tasks is the use of marketing authorizations. The AR control must be completed before an application of the device can be made. The appointment is based on an establishment license for the AR and a specific agreement or mandate between the two parties. The SFDA Guidance for Medical Devices Authorized Representatives contains a recommended model agreement. It is essentially a Saudi company with an agreement signed with a legal medical device manufacturer to act on their behalf in Saudi Arabia. The authorized representative company does not necessarily hold commercial rights in the market, but facilitates the marketing and sales process by ensuring compliance with the legislation. Currently, there is no list; and soon, SFDA will enter into agreements with some companies regarding the issuance of certificates of compliance for imported cosmetic products and will be duly announced after approval. The validity of the AR agreement is at least two years. Note that the validity of the AR license issued must not exceed the validity of the AR agreement.
The applicant can apply for an AR for a period of one year, two years, etc., and taxes are calculated accordingly. The SFDA has published a model of authorized agreement of certain medical devices, which can be used as it is, as it has minimum clauses of requirements. Note that: It is possible to name a distributor as an AR. However, this can lead to unforeseen complications, particularly for SFDA applications and other complex regulatory issues. . The regulations adopted the overall definition of a medical device with a formulation similar to that of GHTF/EC/Australian/Canadian. KSA contains implantable, general and in vitro medical devices and their active implantable accessories. In addition, contact lenses and lasers for cosmetics are included.