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Dear Jane. The Norwegian Heath Ministry is coming to visit Astomed Norway the 26th September in Norway. This is to follow up that we comply with Norwegian regulation for sales and marketing of medical devices. This is a routine visit and normal in the industry for Norway. We are going through the documentation to date, and we are missing for your ILead products: • Updated CE certification • Instructions for use (in Norwegian) • Letter of conformity Astomed must have this information before the 26st September 2023. If we don’t get it, we risk that the government will forbid the sales of your products in Norway. It’s the manufacturers responsibility to comply with these regulations. Can you please provide this email to your regulatory affairs department and as well confirm that the documents will be made available for us. Kind regards from
