How to sell Medical Devices Online ? [EU and FDA]

Since the implementation of EU MDR, there was a new phenomenon about Medical Device online sales. Online sales see their submissions to platforms like amazon rejected as they do have not all the documentation needed. This is also the same in the US market and it will become the same with EU IVDR when the date of implementation will start.
So how do get in compliance? I have interviewed Michael Wetherington who will provide us some hints on what should be done.
If you need any support, don't hesitate to contact me. I will then forward your request.
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► Who is Michael Wetherington?
Michael Wetherington is the Founder of MedicalRegs.com. MedicalRegs.com helps MedTech startups design devices with the applicable requirements in mind. They go further by providing regulatory services for the EU, US, Canada, and ASEAN markets. His background encompasses medical device R&D, accredited testing lab, and Notified Body experience. He is also a mentor at Elemed’s Mentoring Academy. And, when time permits, he likes to sing, play the drums, and the guitar.
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► Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses...
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► Links from the Video
■ Michael Wetherington Linkedin: / medicalregsdotcom
■ CE marking Blue guide: eur-lex.europa...
■ MedicalRegs website: www.medicalregs...
■ Easy Medical Device newsletter: easymedicaldev...
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► Social Media to follow
■ Monir El Azzouzi Linkedin: / melazzouzi
■ Twitter: / elazzouzim
■ Pinterest: / easymedicaldevice
■ Instagram: / easymedicaldevice
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#easymedicaldevice #medicaldevice #regulatorycompliance

[@NancyHuber-ld9hh]

Hi, how do I get in touch with Michael Wetherington? Wondering if online sale of compression nebulizers is allowed on Amazon within the United States

[@EasyMedicalDevice]

Amazon will ask you some documents to prove that the product is registered in the US. And also that you havr a US Agent. If you need help let us know at easymedicaldevice.com

[@Valenthior]

Perhaps my understanding is not right, but it seems that you are talking about resellers (distributors?) Of product that should be MD but are not yet (ex. Not the right classification / lack of technical file) but what if I want to distribute a device made by a major manufacturer that we know as a RA team to have a real MD. Then, as a reseller, which level of paperwork should I build? Would it be enough to ask him is DoC, write down a contract basically saying he keeps all the responsibilities over his product without looking at anything else (ex. Risk management file) ?

[@csoutsource]

Did you find an answer to this?

[@Str8representing]

timecode for FDA please?