Importers or Distributors: Who is Responsible for Medical Device Compliance?

Understanding the responsibilities of importers and distributors is fundamental to ensuring that medical devices comply with regulations and safely reach markets. Here’s a clear breakdown:

Importer vs. Distributor: What’s the Regulatory Difference?

Importer: This is the person or company responsible for bringing medical devices from the manufacturing country to the local market. Their responsibilities include ensuring the device complies with MDR/IVDR regulations, is properly CE marked, and that all documentation is in order. They must also ensure that storage and transportation conditions are adequate and maintain a record of any complaints or non-conforming devices.

Distributor: This is the intermediary who makes the medical device available in the local market. They need to verify that the device has the CE mark, that the Declaration of Conformity is available, and that all manufacturer-provided information is correct. They are also responsible for managing any issues or complaints and ensuring that storage and transportation conditions meet safety requirements.

Why is it important to understand these differences?

Fully understanding the responsibilities of importers and distributors is essential for successfully navigating regulations and facilitating market access.
Being well-informed allows you to tackle regulatory complexities with confidence, ensuring that your medical devices meet all necessary requirements to operate safely and compliantly.

Do you have questions or need more information?

We’re here to support you and provide the answers you need to overcome your regulatory challenges.