Cost of maintaining CE Mark Regulatory Approval

JoCam

JoCam

Trusted Information Resource
#1
#1
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
 
Last edited:
GAGEpack - Gage & Calibration Management
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Q

qpled

#3
#3
Hi Jo. Best of luck with your plans for approvals in all these countries. I do not have any numbers for you but by coincidence I just this morning found a white paper on this topic - it is available from the TUV SUD America website and is called 'Accessing International Markets with a Compliance Strategy'. It includes a sample list of some somewhat recent regulatory changes in a few countries, including some of the countries you listed. One of the themes of the paper is that regulations keep changing, so budgeting can be tough but worthwhile as a way to access these markets.

Quick question: your appliance removes smoke, is this smoke that is generated by the laser?
 
JoCam

JoCam

Trusted Information Resource
#4
#4
Thank you qpled. I shall take a look at that paper.

Yes, our device removes smoke produced from electrosurgical devices by ionisation.
 
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