This message was posted by a user wishing to remain anonymous
Greetings,
I work for a US-based company that manufactures low-risk (typically Class I) medical devices. We have an importer in the United Arab Emirates (UAE), and we recently found out that they have been selling our products to customers in Saudi Arabia, Kuwait, Qatar, Oman, and Bahrain.
Based on the (sometimes limited) information I could find online, it seems like Qatar and Bahrain require a locally-based representative to act as importer, and Kuwait requires a local representative and registration. Our UAE-based importer is saying that it is common practice for customers in neighboring countries to purchase medical devices from them and that registration is not required in Kuwait as long as a certificate of origin and US FDA CFG are provided.
Saudi Arabia pretty clearly requires an extensive approval process, but our importer is saying that MOH-affiliated hospitals in Saudi Araba can purchase non-registered products when there is an urgent need for them.
For those of you with experience in the Gulf countries--is our importer correct?
- Is it acceptable from a regulatory point of view for imported product in the UAE to be sold to neighboring countries?
- In Saudi Arabia, if a tender is received from an MOH-affiliated hospital for a non-registered medical device, does that constitute a legitimate exception that allows for sale into Saudi Arabia?
Thank you!