Countries that accept 510k approvals - Class II nonsterile medical device

#1
Hello Cove,

I work for a company with 510k approvals on a class II nonsterile medical device. I was wondering what international markets accept the 510k approval as part of their regulatory approval process? Most of the info I've found is 5+ years old at least. We're wondering what markets we can enter with our current approvals since our plans for getting a CE mark are on hold until we can get a Notified Body to accept a new client.
 
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Ronen E

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#2
510(k) clearance is not an "approval", and you might want to be careful in stating otherwise.

Australia recognises 510(k)'s but doesn't provide "automatic" clearance on that basis. There are additional requirements.
 

Watchcat

Trusted Information Resource
#3
Did you check the Emergo website? Or is that the information that is 5+ years old?

There are a good number of countries that, like Australia, will expedite, but few to none that will automatically clear. I would check Asia/Pacific and Latin America. I think there are enough countries in both regions that it will be a long way from looking for a needle in haystack. If you don't have ISO 13485 certification, you may run into problems with some countries that require a QMS, since FDA does not issue certificates after facility inspections.

PS Before you rush out to get expedited clearance, it would be wise to confirm that there is a market for your device in that country.
 
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