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Regulatory Requirements for Exporting Medical Devices to Bonaire

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  Post Number #1  
Old 11th July 2018, 07:26 PM

Total Posts: 1
Question Regulatory Requirements for Exporting Medical Devices to Bonaire

Do medical devices being exported from the US to Bonaire need to follow the same regulatory requirements as if they were going to the Netherlands?

From my research, the Netherlands require an authorized representative to register a medical device with their regulatory authority and IFU must include Dutch.

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  Post Number #2  
Old 13th July 2018, 10:33 AM

Total Posts: 771
Re: Regulatory Requirements for Exporting Medical Devices to Bonaire

As this remains unanswered I'll step in.
Bear in mind that the 'facts' that I mention come from Wikipedia - so cannot be guaranteed!

Bonaire was, until 2010, part of the Netherlands Antilles - a nation state. But that was dissolved with Bonaire becoming a Dutch protectorate - effectively part of the nation of The Netherlands.

As such, I would expect that all medical device restrictions and registrations would match those of The Netherlands using the European MDD (soon to be MDR).

I would also expect that the required Authorised Representative could be in any part of the EU but registration should be with the Dutch Competent Authority.

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