Quality management certification required by Health Canada

#1
Hello,

We need a quality management certification for the approval of Health Canada. I was wondering if ISO 13485 certification is valid for a single product or for the entire company? If we develop a new product using our quality management system do we need another certification or is the other still valid?

Thanks for your help
 
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#2
For Canada, you have to be certified according to MDSAP. It is based on ISO 13485 with several additions. It is a costly process.
If you develop another product that falls under the same scope of your quality system, you do not need to be re-certified to MDSAP. But you do need to submit an application (Technical Documentation) to Health Canada. Subsequently, you will get a new license from them.
 
#3
Thank you, that is really helpful,

We are currently using ISO 13485. What can we use to be certified according to MDSAP, is there a standard? Or a list of the several additions to add to our system?

Thank you

MP
 
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