We are planning to sell a Medical Device Group

[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!

 

[Marcelo]

We are planning to sell a medical device group, consisting of individually licensed devices (both Class II), made by the same manufacturer (Focal). 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?

You do not need to apply for a license if you are Focal, which is the manufacturer of both devices. If you are not Focal, that guidance does not apply to you.

I'm understanding you are talking about this guidance (emphasis mine):

Subsection 31(1) states that a MEDICAL DEVICE GROUP is deemed licensed if all the devices that constitute the group are made by a single MANUFACTURER and are individually licensed. This allows a MANUFACTURER to bundle some of their products, normally offered for sale individually, into promotional packages without the need for additional licences. Under these conditions, the individual devices must maintain their labelling as detailed in their individual device licences.