Revised MDSAP Audit Model - Health Canada - October 30, 2017

jiligan

Starting to get Involved
#1
Health Canada sent a notice on October 30, 2017, stating:

Health Canada has received comments from Canadian medical device licence holders regarding the current audit-time model for MDSAP and subsequent annual surveillance audits. To address these comments, the MDSAP Consortium has implemented the following changes:

Streamlined the MDSAP audit approach in the revised version of the audit model.

Does anyone know where I might find this "Revised" Audit Model that they are referring to?

Thanks!:thanks:
 

jiligan

Starting to get Involved
#3
Thank you Sidney Vianna for the link to the Audit Companion and Model. I realize the Companion was revised in April 2017 and the link reflects that revision, however I believe there may be a revision to the Audit Model that is not on the FDA site. Could it be that it is newly released and not been added to the FDA site? :thanx:
 

Edward Reesor

Involved In Discussions
#4
The announcement itself wasn't very informative because of the very issue you stated above. As a small company, I should expect a 20% reduction, but then all manufacturers will receive a 20% reduction, so am I to expect a 40% reduction in audit time?

I just sent a request for detailed information to Health Canada from their website (on the announcement page contact - qs_mdb_hc@hc-sc.gc.ca) and will forward any response I receive.
 

mihzago

Quite Involved in Discussions
#8
Sidney provided a link to a document that is the source of the change mentioned in the notification from Health Canada.
If you notice, the updated Procedure in section 5.3.6 allows for reduction in time up to 20%, but not for everyone, only for companies with less than 15 people; or 10% for companies with 15-45 people.
 

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