The validity of the AR contract is at least two years. Note that the validity of the AR license issued cannot be longer than the validity of the AR agreement. The applicant may submit an application for a royal royalty for a period of one year, two years, etc., and the fees shall be calculated accordingly. The SFDA has published a specific template for the Agreement on Authorised Medical Devices, which can be used as it is, as it contains the required minimum clauses. Note that for now, there is no list; and soon, SFDA will conclude agreements with certain companies regarding the issuance of certificates of conformity for imported cosmetic products and will be duly announced after approval. It is essentially a Saudi company with a signed agreement with a medical device manufacturer to act on their behalf in Saudi Arabia. The authorized entity does not necessarily hold commercial rights in the market, but facilitates the marketing and sales process by ensuring compliance with the legislation. For more information, see the SFDA Medical Devices Sector websitewww.sfda.gov.sa/en/medicaldevices/Pages/default.aspx All foreign manufacturers must appoint a KSA Authorized Representative (RA). This RA assumes, on behalf of the manufacturer, all obligations arising from the interim regulations and represents them before the SFDA. One of these tasks is the application for marketing authorisation. The designation of the RA must be completed before a device application can take place. The appointment is based on an establishment license for the RA and a specific agreement or mandate between the two parties.
The SFDA Guidance for Medical Devices Authorized Representatives contains a recommended standard agreement. The official announcement, 12/10/MDA-AN001, published on 29.12.2010, changed the initial implementation dates. The announcement states that in 2009, the medical device sector of the Saudi Food and Drug Authority (SFDA) issued the Medical Devices Interim Regulations. These include implementation dates that have been changed to August 14 and December 31, 2011 (as shown below). Despite the interim title, these rules should apply for at least five years. They place requirements on importers, distributors, agents, foreign manufacturers and local manufacturers. This article summarizes these rules and focuses on foreign producers. SGS understands that all imports for sale in the KSA and, in particular, products that are new to the KSA market, apply. So far, no restrictions have been placed on the import and sale of medical devices, although the Gulf Co-operation Council (GCC) has examined some manufacturers as a condition of access to large state-funded tenders. In Saudi Arabia, the Saudi Food and Drug Authority (SFDA) requires medical device manufacturers to mandate an authorized representative company (AR) to legally act in the Saudi market on their behalf. It is responsible for the registration of medical devices, compliance with SFDA rules, safety and the implementation of the necessary measures. .