Hi All,
We manufacture a medical device that is used during laporoscopic surgery to remove smoke and provide the surgeon with a clear field of view. The device is a class IIb in Europe and has been awarded a CE mark. The plan for 2015/2016 is to achieve registration for this device in Japan, China, Brazil, Russia, Canada and South Korea.
I have been asked to put together the regulatory budget for this plan, and need to establish the associated costs. Whilst I appreciate that the cost of initial registration can vary dramatically depending on testing required, translations and complexity of the device, I would expect the cost of maintainance once achieved to be a little more consistent.
Would anyone be able to provide me with an approximation of the annual costs of maintaining regulatory approval in the countries stated?
Thank you in advance, and Happy Holidays.
Jo
We manufacture a medical device that is used during laporoscopic surgery to remove smoke and provide the surgeon with a clear field of view. The device is a class IIb in Europe and has been awarded a CE mark. The plan for 2015/2016 is to achieve registration for this device in Japan, China, Brazil, Russia, Canada and South Korea.
I have been asked to put together the regulatory budget for this plan, and need to establish the associated costs. Whilst I appreciate that the cost of initial registration can vary dramatically depending on testing required, translations and complexity of the device, I would expect the cost of maintainance once achieved to be a little more consistent.
Would anyone be able to provide me with an approximation of the annual costs of maintaining regulatory approval in the countries stated?
Thank you in advance, and Happy Holidays.
Jo
Last edited: