Quality management certification required by Health Canada

Marie-Pier

Registered
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
 

shimonv

Trusted Information Resource
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.
 

Marie-Pier

Registered
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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