Despite the downturn in the global economy, Canada remains an important and growing market for medical device manufacturers. However, differences between Health Canada and FDA regulations and device classifications have resulted in some confusion over the best approach to take when entering the Canadian marketplace.
This presentation covers the basic steps you will need to take to obtain the appropriate licences for your company and/or medical device (e.g. Medical Device Licence or Medical Device Establishment Licence). The presentation includes a discussion about the Canadian Medical Device Regulations, the role of ISO 13485:2003 CMDCAS, and issues related to language translation.
Marketing Your Medical Device in Canada was presented by Daryl Wisdahl, Director, with Wisdahl Consulting Group and aired on 2008-11-20. For more details, or to download this conference please visit our site at www.fxconferences.com
