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

[jiligan]

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!

 

[Sidney Vianna]

The MDSAP Audit Model documents and associated command media are available @ this link.

 

[jiligan]

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?

 

[Edward Reesor]

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 - [email protected]) and will forward any response I receive.

 

[jiligan]

Edward Reesor thank you! Any information that you can share on this subject would be greatly appreciated.

 

[Sidney Vianna]

Could it be that it is newly released and not been added to the FDA site?

I am not an expert on this, but, from what I gathered, the "changes" are related basically to the minimum audit time, what was captured in the Audit Time Determination Procedure which is dated 2017-08-31.

 

[jiligan]

Thank you Sidney Vianna!

 

[mihzago]

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.