One of the most common questions we receive is whether a company needs to obtain its own license in order to import medical devices from outside the European Union.
The answer is simple:
Not necessarily.
Although many companies choose to apply for their own importer authorization, it is also possible to operate through an already authorized entity, thereby avoiding the need to shoulder the full regulatory burden associated with this activity from the outset.
This includes aspects such as appointing a Technical Manager, implementing procedures, conducting document reviews of products, verifying regulatory compliance, and managing import operations.
Therefore, before embarking on a process that may require time and resources, it is advisable to understand what options are available and which one is best suited to each project.
If I don’t import directly, should I contact you as a distributor?
The answer will depend on the role the company will play. If you purchase, store, or sell the product in your own name, you must review the applicable obligations as a distributor.
However, there are also models in which the company acts solely as an intermediary between an authorized importer and the end customer, without necessarily assuming the same regulatory obligations.
Therefore, before embarking on any project, it is essential to analyze how the operation will be structured and what role each party will play.
Each project may require a different solution. For this reason, before making a decision, it is advisable to examine the business model, the responsibilities each operator would assume, and the various options available for conducting the business safely and in compliance with current regulations.
Not sure which option is best for your project?
At MD Import, we can help you analyze your situation and evaluate the various options available.