Since the authorized representative must be a local Saudi company, legal producers have two options. One is to assign their local distributor as AR or to outsource it to a more regulated company. Most of the time, the strength of the local distributor lies in marketing, prompting many medical device manufacturers to designate a consulting firm as an authorized representative in Saudi Arabia. Can we choose a distributor like our representative at KSA? How is an authorized representative chosen? How do you switch to a new agent at the KSA? It is possible to obtain a new agent; However, it requires a new AR license. You must cancel the existing AR license before you license a new one. You cannot send an AR transfer requirement if your MDMA application is in progress. Emergo is happy to help you with AR transfer requests. 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: An experienced third party representative is in the best position to serve the best interests of your company in Saudi Arabia. Your AR must ask questions of the SFDA and, if necessary, comply with post-market obligations. You should protect your intellectual property and allow you to control your distribution options. How do you switch to a new agent at the KSA? 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. The DRC is a plenipotentiary representative. In accordance with SFDA rules, the foreign medical manufacturer must appoint a local authorized representative who acts as a communication channel between the manufacturer and the SFDA. It helps manufacturers in cosmetic services such as first authorization, new manufacturer license and updating the licensing requirement. In 2009, the Medical Devices Sector of the Saudi Food and Drug Authority (SFDA) issued the Medical Devices Interim Regulations. These include implementation dates, which were amended to August 14 and December 31, 2011 (as noted below). Despite the intermediate title, these rules are expected to apply for at least 5 years. They impose requirements on importers, distributors, agents, foreign manufacturers and local manufacturers. This article summarizes these rules and focuses on those concerning foreign producers. In Saudi Arabia, the Saudi Food and Drug Authority (SFDA) is asking medical device manufacturers to appoint an authorized representative (AR) to act on their behalf in the Saudi market.
It is responsible for the registration of medical devices, compliance with SFDA rules, safety and implementation of necessary measures. All foreign producers 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.