SOP Template for seeking regulatory clearance - MDSAP

[hornet456]

Fellow members,

We are undergoing a stage II MDSAP audit for Canada, US and Australia for our class II medical device. The auditor asked for our SOP on how we seek regulatory clearance in these three countries, and how we keep our licenses active.

Given the apparent generic nature of this information, do you have any templates that I could use? Or would the SOP involve outlining the regulatory steps needed to achieve clearance, such as the 510(k) decision flowchart etc?

Any guidance that you can provide on this is greatly appreciated. Thank you for your time.

 

[yodon]

Curious as to what requirement your auditor is citing that requires such a documented procedure?

 

[hornet456]

Hi yodon,

Thanks for your response. It's a finding from our MDSAP stage II audit - the auditor indicates that we need an SOP for communicating with regulatory authorities, both in terms of reporting adverse events as well as other general communication.

Thank you.

 

[yodon]

Can you post the finding with the exact wording? That is usually helpful in providing feedback.

 

[hornet456]

Yodon,

The statement of non-conformity says: "Complaint handling procedure and the notification of adverse events procedure do not the meet US, Canada and Australia requirements for processing customer complaints and notification of adverse events"

 

[yodon]

That's helpful. The auditor shouldn't be saying you need a Communications SOP (that's consulting) but that you have apparently failed to provide documented procedures for the relevant communications requirements.

In 13485, there is:

8.2.3 Reporting to regulatory authorities
If applicable regulatory requirements require notification of complaints that meet specified reporting criteria of adverse events or issuance of advisory notices, the organization shall document procedures for providing notification to the appropriate regulatory authorities.

In the US, there's 21 CFR 803 which has:

If you are a user facility, importer, or manufacturer, you must develop, maintain, and implement written MDR [medical device reporting] procedures ...

Not sure what the Canadian or Australian requirements are (other than the 13485 reference) but if you don't have procedures addressing these, the finding is legitimate.

I think most companies have some kind of (adverse event) Reporting SOP. (Complaint investigation may determine that the complaint is a reportable event so it generally references the Reporting SOP. From the finding wording, it sounds like you don't have a Complaint Handling procedure - that's another one that most companies have.)

You'll need to look at the specific requirements for each country to determine the extend of your reporting (communications) procedures.

 

[hornet456]

Yodon,

Thanks for the response and the details, this is very helpful. My mistake earlier, when I said the auditor indicated the need for a communication SOP - it was actually our regulatory affairs manager.

We're planning to lay out a document much like what you recommended, based on per country requirements, at least in the territories that are relevant to our company.