Hi all,
I have a request to ship our product to Saudi Arabia and Dubai. We currently have CE mark (class III product) but not FDA approval. Does anyone know the medical device regulations in either of these geographies? Are there import requirements that may also apply?
I found this info on the Saudi Network website under the Importation of Medicines and Pharmaceuticals section
"...imports of pharmaceuticals and medicinal products require a certificate issued by the Exporting country Department of Health and Human Services stating that the medicines are actually used by the public in the Exporting country under the same trade name and formula and must include the name of each product, the formula, and the date and number of the permit to manufacture them if one is required. "
Does anyone know if this also applies to Medical Devices?
Thanks!
I have a request to ship our product to Saudi Arabia and Dubai. We currently have CE mark (class III product) but not FDA approval. Does anyone know the medical device regulations in either of these geographies? Are there import requirements that may also apply?
I found this info on the Saudi Network website under the Importation of Medicines and Pharmaceuticals section
"...imports of pharmaceuticals and medicinal products require a certificate issued by the Exporting country Department of Health and Human Services stating that the medicines are actually used by the public in the Exporting country under the same trade name and formula and must include the name of each product, the formula, and the date and number of the permit to manufacture them if one is required. "
Does anyone know if this also applies to Medical Devices?
Thanks!
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