B
We manufacture Class II and Class III devices. Two of our devices used to be manufactured by a contract manufacturer on our behalf, however, we are now eliminating the contract manufacturer and manufacturing in-house in the same location we manufacture our other licenced devices.
All our device licences only list us as the manufacturer, there is no mention of the contract manufacturer on any licence. Do we need to submit any amendments to Health Canada for this change of bringing the manufacturing in-house?
On the same token, does anyone know if there would be any need for an FDA submission for the same change for the same devices?
Thanks!
All our device licences only list us as the manufacturer, there is no mention of the contract manufacturer on any licence. Do we need to submit any amendments to Health Canada for this change of bringing the manufacturing in-house?
On the same token, does anyone know if there would be any need for an FDA submission for the same change for the same devices?
Thanks!