This may be a complex timeline based on your device, where device is marketed, and when subsequent marketing update approvals have been obtained. There is no "required timeline" for once the change has been approved by a regulatory agency. In fact, I know companies having received a 510(k) clearance in the U.S. that did not market their device for almost a year later. Once you receive market approval, it is up to your organisation to determine when the change is released to market. As you indicated it can be complex if you have multiple major markets where you can not release the change in manufacturing because other market approvals may have not been obtained yet. This is what is so crucial for having a Quality Plan/Development Plan/any kind of plan outlining the timeframes, acceptance criteria, and when actual events would occur. Such that if you anticipate receiving market approval for US and Canada in February, Brazil in April, and Japan in May, then your plan would have a trigger to go full launch in June. Depending on your device and your inventory system you could also launch different versions or models in different countries based on when you receive market approval for the change. This is much more complex because internally you would need to manage part numbers for the pre-change and post-change version, then your inventory system should be sufficient to "block" country shipments until the approval of change is received. This is much more complex to manage multiple part numbers. However, there is no required timeline to implement a change once you received approval, this is up to you as an organisation.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 18-Oct-2019 04:54
From: Anonymous Member
Subject: Implementation timeline of significant changes to devices
This message was posted by a user wishing to remain anonymous
Can anybody please provide feedback regarding how quickly significant design changes are required to be implemented after regulatory approval is received for said changes?
For example, when a design change impacts multiple countries, registration amendments will likely be approved on various dates, depending on CA timelines and the complexity of the amendment requirements in each country. If, say, Canada were to receive amendment approval 12 months ahead of Brazil, would it be possible for the manufacturer to hold implementation of the change and continue manufacturing and distributing the legacy design in Canada until amendment approval is received in Brazil? Or is there an expectation by Health Canada for the change be implemented immediately after the amendment is approved?
Obviously there must be an allowance of some time to fully implement the change before the modified product can be released to market, but does anybody have any idea of how long a change can be prolonged in major markets like US, Canada, Brazil, Japan, etc after regulatory approval is received for the change?