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.
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.