Canada Medical Device - Definition of "Manufacture", "Company? and "Distribute"

DannyK

Trusted Information Resource
#11
Company B has an ISO 13485 CMDCAS certificate can change their scope to include the medical device.
Company A can private label the medical device from company B.
 
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rayahuang

#12
Thank you Danny.

Now we have the situation that company A has received the F202(Submission of a New or Modified Quality Management System Certificate )from health Canada ,can company A fill the manufacture as company B and send it to health canada to renew Quality Management System? And the manufacture will become company B?

Is it the right process?
 

DannyK

Trusted Information Resource
#13
Thank you Danny.

Now we have the situation that company A has received the F202(Submission of a New or Modified Quality Management System Certificate )from health Canada ,can company A fill the manufacture as company B and send it to health canada to renew Quality Management System? And the manufacture will become company B?

Is it the right process?
It requires completing a private label application and an agreement. I have done several with no issues from Health Canada. If you want more specific information, you can send me a private message.
 
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