Search the Elsmar Cove!
**Search ALL of Elsmar.com** with DuckDuckGo including content not in the forum - Search results with No ads.

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.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#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.
 
#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.
 
Top Bottom