The SFDA requires global medical device manufacturers to appoint a local company to represent them in Saudi Arabia. This process requires signing an agreement between the manufacturer and the local authorised representative company.
The companies have two options when choosing the local AR: an independent AR or appointing the same local distributor as the AR. Those options have huge differences; you can read about that in our article: an authorised representative (AR). You may also read about Medical Device Registration.
You can download the required template from this page to learn the scope and responsibilities of the local representative. Feel free to contact us to answer your questions. You can also schedule a complimentary online meeting to clarify the process and its related regulations.
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