Auditing Organization dragging their heels on issuing our MDSAP Surveillance Audit Confirmation Letter - everyone is nervous ... are we the only ones?

supadrai

Lawyer
Does anyone have the inside scoop - are all the NBs slammed this year and just trying to grind it out? Our customers are getting antsy about placing orders ... and the NB failed to respond completely for a month, then punted to another team without providing any good response. Thoughts? Ideas? Strategies?
 

Edward Reesor

Trusted Information Resource
I believe they are called AO's (Auditing Organizations) and not NB's, but we still haven't had our Correction Plans officially accepted. They were accepted by the Lead Auditor but then they were to go to the company for final approval, and haven't heard anything since. Our NC's were pretty minor and the plans were pretty simple, but that's not the point.
 

supadrai

Lawyer
Sorry - AO. They just ignored us for a month, then responded with a "hot potato" but the person to whom the other person threw the "hot potato" was copied on all correspondence already. How hard can we push? Are there consequences to "getting tough" with them. I didn't even ask for them to commit to a delivery date (assuming we're ok) for the documents - just to give us a non-binding ballpark and to confirm they were not aware of any problem that will prevent them from issuing the document in for us to submit to Canada.

The answer was, "Oh, just got this [despite being copied on all emails], we'll get back to you [unspecified date]."

Our management is getting hyper, our customers don't want to place orders - how is this sausage being made?
 

supadrai

Lawyer
I am crediting the Cove's juju with producing results - just heard back today and we are good to go. Phew.
 

Edward Reesor

Trusted Information Resource
Coincidentally, we just received our confirmation that our Corrective Action Plans have been approved. Please keep in mind that the AO's have been given a very tough task to the extent that the Health Canada has made many accommodations for companies to become certified. I would be very interested in the numbers as to how many companies withdrew from the Canadian market solely because of this mess.
 
J

Jeff Shaw

We have been having serious issues with our AO. Lack of responsiveness, inability to keep dates previously provided and provide new dates, they just can't keep resources.

On the Canadian side, we have licensed class II devices and no longer have a confirmed date for MDSAP. We have been communicating with our AO about MDSAP from day 1. I talked with Health Canada directly, they indicated they aren't going to be cancelling our licenses - even when I indicated we might need to drop MDSAP from our plan for 2019.

My overwhelming concern is our 13485 cert, the resource strain has impacted scheduling our recert to 13485:2016 and they can't tell us when they are coming.
 

supadrai

Lawyer
Glad the regulator seems to be demonstrating some willingness to be flexible. I wonder though, whether they have this discretion or authority.
 

Dan Anderson

Registered
Coincidentally, we just received our confirmation that our Corrective Action Plans have been approved. Please keep in mind that the AO's have been given a very tough task to the extent that the Health Canada has made many accommodations for companies to become certified. I would be very interested in the numbers as to how many companies withdrew from the Canadian market solely because of this mess.

I am a distributor in the US but my manufacturer is in China and I have a customer in Canada that wants to purchase these products. Is there a company that the Chinese manufacturer can work with to take on the MDSAP requirement for them? How long will it take China to get certified if they have to do it themselves?
 

DannyK

Trusted Information Resource
I have worked with some clients in a similar scenario.
Some of MDSAP certified clients added the product to the scope and it cost a fraction of the cost.
The issue that comes up often is sharing of information and labeling.
The resources for medical device audits are scarce especially since Notified bodies are gearing up for EU MDR.
The Chinese supplier should enquire from their auditing organization.
 
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