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How will the new MDSAP requirements affect the MDEL?
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How will the new MDSAP requirements affect the MDEL?
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How will the new MDSAP requirements affect the MDEL?

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health canada, mdel (medical device establishment license), mdsap (medical device single audit program)
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Old 10th August 2018, 02:01 PM
DDWFER

 
 
Total Posts: 1
Question How will the new MDSAP requirements affect the MDEL?

How will the new MDSAP requirements affect the MDEL? Will Health Canada now monitor the manufacturers which are listed on the MDEL to see if they have passed the MDSAP before issuing a new/updated licence?

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  Post Number #2  
Old 11th August 2018, 11:32 AM
shimonv

 
 
Total Posts: 282
Re: How will the new MDSAP requirements affect the MDEL?

Below is the answer directly from Health Canada site:

"Q1: I received a medical device licence using a CMDCAS certificate. Will my licence be suspended if I don’t have a MDSAP certificate on January 1, 2019?
A: Yes. Licences not supported by a valid MDSAP certificate as of January 1, 2019, will be subject to suspension. Holding a valid quality systems certificate is a regulatory requirement for a manufacturer to have an active medical device licence. All device licence applications and F202 notifications received after January 1, 2019, must contain a MDSAP certificate; a manufacturer’s CMDCAS certificate will not be accepted. Additionally, auditing organizations (AOs) will soon begin issuing MDSAP certificates after recertification or special upgrade audits and these are to be submitted to Health Canada using the Form F202 notification process."


Below is another quotation form Health Canada:
"Manufacturers undergoing a full MDSAP audit in 2018 are expected to submit a valid MDSAP certificate with a form F202 (Submission of a New or Modified Quality Management System Certificate) to the Medical Devices Bureau by December 31st, 2018."


So then, Health Canada should have no problem knowing if you made the transition to MDSAP or not. They could even use the annual renewal process to confirm that.


-Shimon
Thanks to shimonv for your informative Post and/or Attachment!
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