National healthcare development company LLC

The following services provides in Russia: - Advice on the current legislation on Medical Devices - Writing and/or revision of the dossier to obtain Registration Certificate for Medical device - Management of Medical device registration process in Russian authority. - Post-approval maintenance for Medical devices. - Regulatory intelligence for Medical devices. - Regulatory labeling for Medical devices. - Manufacturing license for Medical devices - Technical file development for Medical devices (foreign and localized). - Presentation of MDs registration process in English/Russian languages. - VAT exemption for component's shipment of localized Medical device. - IFU development for Medical Devices. - Support to choose the test laboratories for Medical Devices. - Build the strategy of the registration for the foreign/localized Medical Devices. - Market analysis for Medical devices - Consultation to the manufacturers to develop the optimal production localization scenario in Russia & EAEU. There will be provided the methods of localization as contract manufacturing, own production, joint-venture company and all thier advantages and disadvantages.

• Employees 3