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Regulatory Importer Services

Exercise more control over compliance in your distribution chain – without disrupting the way you import your devices today.

Medical Device Regulatory Importer Services in the EU, UK, Switzerland, and India

We perform many tasks to ensure your ongoing compliance with the EU, UK, Swiss, and India regulations without the need to take title or take physical possession of your devices.

EU Regulatory Importer

UK Regulatory Importer

Swiss Regulatory Importer

India Regulatory Importer

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Compliance Done Remotely Without Disrupting Your Supply Chain

We perform many tasks to ensure your ongoing compliance with the EU, UK, Swiss, and India regulations without the need to take title or take physical possession of your devices. Our compliance checks are done electronically and efficiently. By reviewing and confirming compliance after you have already shipped your devices, it is not necessary for you to hold up shipments or alter the way you ship today.

Streamline Operations with a Proven Process

Streamline Operations with a Proven Process

Our compliance checks are done electronically and efficiently. By reviewing and confirming compliance after you have already shipped your devices, it is not necessary for you to hold up shipments or alter the way you ship today.

Maintain Flexibility and Commercial Control

As an “independent” Regulatory Importer, MedEnvoy is solely focused on executing importer obligations and ensuring compliance. There is no need to take physical possession of your devices, so you won’t need to change the way you do business to meet the many regulatory requirements.

Compliance Done Remotely Without Disrupting Your Supply Chain

As your partner, we’ve got your back every step of the way.

We Verify

Our team verifies that your devices are compliant and have been registered with the relevant authorities under the applicable database.

We Notify

You’ll know immediately if any product complaints or adverse events are reported to us. No guesswork here.

We Check

We ensure that your product labeling, IFU, UDI, and other documentation are present and correct.

We Coordinate

We coordinate closely with economic operators and competent authorities and guide you through next steps if a device problem arises.

What if my distributor doesn’t want to be my regulatory importer?

The Regulatory Importer is primarily a “behind the scenes” operator, with many responsibilities in placing your devices on the market. It is financially liable if non-compliant devices are placed on the EU market. Distributors are not. That’s where we can help.

What happens if I don’t follow regulations?

The fines levied by each EU country can be significant if obligations are not correctly followed, particularly if these have led to noncompliance with the applicable regulations. Distributors may not be up to the task of fulfilling those obligations.

Do I need to disclose the identity of my Regulatory Importer?

Your selected Regulatory Importer needs to be clearly identified up to the point where the device is “put into service.” In practical terms, this means all the way to the end user. When you have multiple distributors, having one of them identified as the importer may not be commercially acceptable to your other distributors.

Related Guidance

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