Hi Rashmi,
The way that changs are assessed, with respect to regulatory impact, varies fairly significant (at least in my opinion) by market, just as requirements for initial registration require. So to answer your first question, yes, there are definitely examples where a change is considered significant for one market and not for others. As a general example, Japanese requirements seem, at least in my experience, to require notification and/or approval more often than not, often for changes which do not require any post-market regulatory notification for other markets.
Regulatory impact needs to be assessed for all countries where your product is legally sold to determine if there are any notification or approval requirements. I have seen more informal assessment methods, where changes are individually researched (not efficient) and documented, and more formal assessment methods which involve maintaining documents with change requirements for individual countries or spreadsheets which allow you to filter by change type and country.
Hope this helps,
Liz
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Elizabeth Goldstein RAC
Regulatory Affairs Specialist
Medtronic Vascular
Santa Rosa CA
United States
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Original Message:
Sent: 04-Aug-2017 08:44
From: Rashmi Pillay
Subject: Significant changes to QMS &devices
Hi,
There are guidances for notification of significant changes to the notified body (EU) , FDA , TGA , Health Canada etc. Has there been an instance where a significant change assessed for a country is not significant for others ?. How does a QMS procedure adequately cover the regulations /requirements of all the countries?
Regards,
Rashmi