Import & Export of Medical Devices

Everything you need to know about import and export of medical devices!

In the world today where import and export of medical devices is bound with several challenges, it is vital for the medical device companies, wishing to scale, to comply with all the regulatory requirements for import and export of their products.

Import and export of medical devices involve a multitude of documentation requirements to ensure compliance with regulatory standards and facilitate the movement of these products across international borders.

Below, we have outlined the different types of documentation typically required for both medical device import and export and what we help you create -

Documentation Required for Medical Device Import

Import License or Permit

Many countries require importers to obtain a license or permit from the relevant regulatory authority before bringing medical devices into the country. This license demonstrates compliance with local regulations.

Commercial Invoice

A detailed invoice from the supplier, including information about the medical devices, their quantities, values and other commercial terms. This document is crucial for customs clearance and assessing import duties.

Bill of Lading or Airway Bill

These documents serve as proof of the shipment's ownership and specify the terms of delivery. The Bill of Lading (BoL) is used for shipments by sea, while the Airway Bill is used for air shipments.

Packing List

A detailed list of the contents of the shipment, including information about each medical device, its packaging, weight and dimensions.

Certificate of Origin

This document states the country of origin of the medical devices and is necessary for trade agreements, customs valuation and import restrictions.

Insurance Certificate

If applicable, this certificate covers the shipment against damage or loss during transit.

Import Declaration

A formal document submitted to customs authorities, providing details of the imported medical devices, their value and their intended use. It is essential for customs clearance.

Customs Entry Forms

Depending on the country, specific customs entry forms may be required, such as the Single Administrative Document (SAD) in the European Union.

Regulatory Compliance Documents

These include product certifications, such as CE Marks for European markets or FDA clearance in the United States. They demonstrate that the medical devices meet regulatory requirements.

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Documentation Required for Medical Device Export

1. Export License or Permit

Some countries require exporters to obtain licenses or permits to legally export medical devices. The specific requirements vary from one country to another.

2. Commercial Invoice

Similar to import documentation, an invoice detailing the medical devices, their quantities, values and commercial terms.

3. Bill of Lading or Airway Bill

As with imports, these documents are needed to confirm ownership and define the terms of delivery for international shipments.

4. Packing List:

A detailed list of the exported medical devices and their characteristics.

5. Certificate of Origin

This document confirms the country of origin of the medical devices and is crucial for customs compliance.

6. Export Declaration

A document submitted to the relevant export authorities, providing information about the exported medical devices, their destination and the exporter's details.

7. Transportation and Shipping Documentation

This includes documents related to shipping, such as the Booking Confirmation and the Shipping Instructions.

8. Export Compliance Documentation

Depending on the destination country, you may need to provide additional regulatory compliance documentation, such as product registrations or certificates of conformity.

9. Quality Management System Documentation

Some countries may require evidence of adherence to quality standards, such as ISO 13485, as part of the export process.

10. Importation Documents for Destination Country

Documentation required by the destination country's customs and regulatory authorities, which can include import licenses or permits and compliance certificates.

Keep in mind that the specific documentation requirements may vary significantly from one country to another and can change over time due to updates in regulations. Therefore, it's crucial to work closely with medical device regulatory consultants in international trade and regulatory compliance or consult with the relevant authorities to ensure that you have the correct and up-to-date documentation for your medical device import and export operations.

We, at Elexes Medical device consulting offer best support to medical device manufacturing companies with all these import as well as export documentation without which you cannot take your medical device to international markets.

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So, if you are looking to scale your medical device market, all you have to do is contact us!

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Our New Product Approval Service Corner

We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -

Global Regulatory Strategies

Creating a new medical product can be challenging in itself. Add a bit of regulatory formalities on top of it and it can become a nightmare for any medical device manufacturer to take care of it all at once. With our experience in working with different regulatory authorities around the globe, you can relax back while we create a successful global regulatory strategy for you through different services like - International regulatory strategies, FDA 513(g) request, product classification, Q-submission and international registration.

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Before you even consider submitting a new product for regulatory approval, it is essential that you have a strategy in place for determining the best pathway to get clearances in one-go. The good thing with us is that we will have you prepared for all your regulatory inspections. Right from preparing and conducting pre-submission mock meetings, creating proper regulatory strategy to evaluating ISO 13485 & compliance for your product, we will help you throughout.

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Tom Birney

CEO Masterlink, Arizona

^“ Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms _“

Diane Bryant

CEO Novasignal, Los Angeles

^“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process. _“

Daniel Kinsey

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^“Professional and easy to work with! They expedited CE Marking for our products and also created clinical evaluations, risk assessments, and provided testing/manufacturing advice. _“

Linda Pan

Sr. Exe Treedental, Hong Kong

^“Having Elexes as our import-export expert was a great choice. Elexes' team answered all our questions and guided us through every step. _“

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MD Blackrock Pharma, England

^“Kudos to the Elexes team! They're always proactive and have provided invaluable support to us with import, labels, and registrations. _“

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Owner Liz Inc., Arizona

^“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time. _“

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CEO Radformation, New York

^“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation! _“

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