S
snoopy2017
We are planning to sell a medical device group, consisting of individually licensed devices (both Class II), made by the same manufacturer. The regulation and guidance explain that we do not need to apply for another licence because the group is deemed licensed if the individual products are licensed. Without applying for a licence, how can we get a certificate recognizing these two devices as a constituents of a medical device group? If a company plans to sell this package overseas, without a physical licence for the medical device group, how can we market this as a package in a foreign country?
Thanks!
Thanks!
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