Happy Friday!
Does anyone have any pearls of wisdom that they could share regarding market clearance in Japan? We are a Class IIa SaMD with CE Marking under the MDR. We are looking to Market in Japan, not the cheapest of markets I believe! Has anyone gone through this process and could share some information regarding fees, timelines, how difficult it was etc.
Thanks
James
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James
Head of QARA
UK
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