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. 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, security and the implementation of the necessary measures. 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. As a result of the interim regulations, a national web-based medical device registry (MDNR) was created. These include the registration and listing of medical devices.
Within the DNDM, all KSA importers, distributors, authorized representatives and local manufacturers must be KSA corporations and obtain an establishment licence for their operation. Each of these operations is considered a separate process, for example. B an authorized representative may or may not be the importer or distributor of a product. Foreign producers may wish to verify that their KSA partners have obtained the necessary licenses. An experienced external representative is in the best position to serve the best interests of your company in Saudi Arabia. Your AR must answer sfDA questions and, if applicable, fulfill post-market obligations. You should protect your intellectual property and allow yourself to control your distribution options. How does the selection of a representative take place? 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 RA for a period of one year, two years, etc. and the fee shall be calculated accordingly. DRC is an authorized representative.
In accordance with SFDA regulations, the foreign medical manufacturer must appoint a local agent who will act as a communication channel between the manufacturer and the SFDA. It helps manufacturers obtain cosmetic services such as first authorization, new manufacturer`s license, and updated license application. 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. How can I switch to a new representative at KSA? It is possible to obtain a new authorized representative; However, it requires a new AR license. You must terminate the existing AR license before requesting a new one. You cannot submit an AR transfer request if your MDMA request is being processed….