Start with a concise description of the device, its intended users, the setting in which it will be used, and its intended purpose. Include the manufacturer, available models, and any related accessories.
Prepare an inventory of available technical documentation, quality-system evidence, labeling, instructions for use, and existing market authorizations. A gap assessment can then identify what requires further work.
Define the markets you want to enter and your proposed importer or distribution arrangement. Requirements and local responsibilities differ across countries, so a pathway should be scoped for each market.
An initial consultation helps turn these inputs into a practical work plan. It does not guarantee an authorization or a fixed authority review time.