Team Elexes 
Elexes Team 
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
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Read MoreDocumentation Required for Medical Device Export
Some countries require exporters to obtain licenses or permits to legally export medical devices. The specific requirements vary from one country to another.
Similar to import documentation, an invoice detailing the medical devices, their quantities, values and commercial terms.
As with imports, these documents are needed to confirm ownership and define the terms of delivery for international shipments.
This document confirms the country of origin of the medical devices and is crucial for customs compliance.
A document submitted to the relevant export authorities, providing information about the exported medical devices, their destination and the exporter's details.
This includes documents related to shipping, such as the Booking Confirmation and the Shipping Instructions.
Depending on the destination country, you may need to provide additional regulatory compliance documentation, such as product registrations or certificates of conformity.
Some countries may require evidence of adherence to quality standards, such as ISO 13485, as part of the export process.
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.
So, if you are looking to scale your medical device market, all you have to do is contact us!
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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
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Diane Bryant
CEO Novasignal, Los Angeles
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.
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Daniel Kinsey
President ViDava, Florida
“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.
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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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Joshua Mink
Manager Outset Medical, California
“Highly recommend Elexes! They always meet commitments and follow through on action items.
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Michal Depa
CTO Jana Care, Massachusetts
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product's nuances quickly.
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Philip McFerran
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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Samip Shah
VP Regulatory AliveCor, California
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.
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Elizabeth W
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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Kurt Sysock
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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