Regulatory Open Forum

 View Only
  • 1.  Significant /Substantial change notification to NB/regulatory agency

    Posted 28-Aug-2017 07:52
    Hi ,

    Needed guidance on requirement of notification of significant change.

    What is the expectation here ? Does it mean that you should have a general procedure based on the notified body guidance for significant changes / FDA guidance of when to submit a 510k or have a more specific one related to your specific processes and devices , define each type of significant change ,? 
    Once this procedure is implemented , then have the regulatory analysis  for each  country ? Is this also the expectation under ISO 13485 : 2016 under the Design Control ?

    TGA mentions substantial and the others significant but I suppose that is interchangeable.



    RashmiEllex MedicalAdelaideAustralia

  • 2.  RE: Significant /Substantial change notification to NB/regulatory agency

    Posted 29-Aug-2017 05:56
    Hello Rashmi, 

    Here is how I am approqching it for ISO13485:2016.  I am creating a general procedure overall that defines how you manage change control with regard to reporting criteria. This means highlightingwhat types of changes are significant and could require reporting or a submission, because it is generally consistent in the major countries. This gives other cross functional groups a heads up on what regulatory or quality would want to know about in advance. You could reference higher level guidances for applicable markets if the broader audience wanted to go read or had insomnia. Then train on this and make everyone know that except for really minor changes, regulatory/ still should know or be involved in change approval. Branding and model/catalogue number changes have bigger impacts globally now, with certificates and UDI in place.

    Then for regulatory/quality I am creating department level procedures for assessing a change. I include published flowcharts for reference so my clients can write up a clear justification for NB reporting or not, or the need for a new submission or resubmission. That assessment will be made in each change record. 

    FDA and Health Canada have pretty good flow charts and the NB guidance is good. TGA, Japan and other countries have them but they are harder to tease out, though consistent mostly with FDA, Canada and EU. I would not create a procedure for each device type, just a more exact procedure incorporating those types of decisional flowcharts as tools or templates the RA or Quality person has to complete to create an assessment. 
    It is good to plan for this now, because even without doing a resubmission, some countries require annual reports of even minor changes to a device, as a requirement of maintaining the license (e.g., Canada).

    That is going to be my approach at the moment. Be sure each country or geography where you are marketing any product  is covered at least in the department level procedures.

    Private message me if needed.

    Best regards,

    Ginger Cantor, MBA, RAC
    Centaur Consulting LLC

  • 3.  RE: Significant /Substantial change notification to NB/regulatory agency

    Posted 31-Aug-2017 09:27
    One option is to create the over-arching SOP and then include specific decision trees for each country where the product is marketed. Change requests are reviewed by the supporting RA professional and the flowchart decision points with notes of where notifications will be required become part of both the review documentation and the generation of action items for notification. The flowcharts can include references to the specific regulations in the specific countries/markets as well as examples of what is considered "substantial", "significant", etc.

    Thomas Hutchinson MS RAC FRAPS

  • 4.  RE: Significant /Substantial change notification to NB/regulatory agency

    Posted 01-Sep-2017 05:49

    Hi Thomas ,

    Thanks for your response. I agree with your advice and is also similar to what Ginger mentioned. 

    Another question , when we have this overarching SOP to cover all the changes included in regulations , could there be chances of over notification for some countries? Like the TGA has issued this Substantial change guidance in June this year and haven't covered Design changes /software changes like in the others , however a general mention of  changes affecting Essential principles of S& E as substantial or those affecting the risk management as substantial . Does it mean the others are not? When the changes are assessed as substantial for the other markets , is it alright to not consider the same approach for  TGA.