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Regulatory Strategy Question

  • 1.  Regulatory Strategy Question

    Posted 29-Jan-2020 15:31
    Hello everyone,

    I'm seeking some advice on putting together a regulatory strategy.  What are some questions I should be looking for?  If anyone has any guidelines on putting together a regulatory strategy, I'd appreciate it. 

    Thanks very much.

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    Karen Zhou
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  • 2.  RE: Regulatory Strategy Question

    Posted 30-Jan-2020 03:54
    Hi Karen,

    Do not take this wrong, but what specifically do you mean 'regulatory strategy' as this could be a large number of aspects from classification, pre-submission work, life cycle of device, etc.  You would have to be a bit more specific on what you mean by regulatory strategy.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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  • 3.  RE: Regulatory Strategy Question

    Posted 30-Jan-2020 04:10
    Hi Karen,

    to add to the specifics mention by Richard, does it concern the approach for one product in different regulatory environments; or the approach for a group of similar products to be registered or certified in one region, or a combination; variations of intended purpose in different regulatory regions, etc.?

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    Peter Reijntjes
    Principal Consultant Regulatory & Quality Affairs
    Arnhem
    Netherlands
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  • 4.  RE: Regulatory Strategy Question

    Posted 30-Jan-2020 05:22
    Dear Karen,

    Some basic questions before you start to define your regulatory strategy:
    Which country/region?
    New product, or change on existing product?
    Regulatory strategy covers only medical device regulation, or also need to consider other regulations in the given country/region?
    What type of product?
    Classification of the product? ​
    What are the applicable standards/guidance for the given product?
    Regards,

    ------------------------------
    Ruojuan(Nancy) Zhang
    Regulatory Affairs Manager
    Netherlands
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  • 5.  RE: Regulatory Strategy Question

    Posted 30-Jan-2020 08:13
    Although I agree with Richard about the vagueness of the question,a good place to start would be Capter 10 of the  Fundamentals of US Regulatory Affairs by Karen Fan and Robert Falcone. They cite the FDA guidance on Target Product Profile and their Table 10.3 has an excellent list of questions to ask in developing a strategy.

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    Glen Park PharmD
    Executive Director, Regulatory Affairs and Quality Assurance
    Jersey City NJ
    United States
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  • 6.  RE: Regulatory Strategy Question

    Posted 30-Jan-2020 16:42
    Who is asking the question about Regulatory Strategy and what is the ultimate ask (i.e. what info are they really looking for)? 

    1. Is it the VP of Marketing/Sales looking for the quickest route to a cleared product (e.g. US - 3 months for a 510(k) vs. Canada - 15 days for an MDL vs. China - a really long time)?
    2. Is it the VP of Product Development looking to understand the technical documentation requirements (think: what is the least amount of work we need to do in terms of defining requirements, testing product, etc. to get product to market)?
    3. Is it the VP of Regulatory looking to plan out the regulatory and QMS work for the next year? The suggestions in this thread are great.

    It boils down to this: Who will spend money on your product and where are they located?  A SWOT analysis from a regulatory perspective would determine which markets to prioritize.

    Oh and thanks for shout out @Glen Park​!  It IS a great chapter :D  @Robert Falcone and I worked hard on it.​

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    Karen Fan MSc RAC PEng
    Manager, Regulatory Affairs and Quality Assurance
    Rostrum Medical Innovations Inc.
    Canada
    ------------------------------



  • 7.  RE: Regulatory Strategy Question

    This message was posted by a user wishing to remain anonymous
    Posted 30-Jan-2020 09:03
      |   view attached
    This message was posted by a user wishing to remain anonymous

    Good old Google:
    https://www.orthoworld.com/index.php/publications/orthoknow_content/five-steps-to-regulatory-strategy-development
    https://www.mddionline.com/whats-difference-between-regulatory-strategy-and-regulatory-plan-5-questions-michael-santalucia
    https://www.slideshare.net/thecapitalnetwork/developing-regulatory-strategy24apr13

    Attachment(s)



  • 8.  RE: Regulatory Strategy Question

    Posted 30-Jan-2020 10:26
    Hi Karen,
    I've attached some old Focus articles that I use as regulatory strategy references.
    Hope they are useful.

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    Hiral Dutia
    Sr. Regulatory Affairs Specialist
    Third Pole Therapeutics
    Waltham, MA
    USA
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  • 9.  RE: Regulatory Strategy Question

    Posted 30-Jan-2020 11:38
    Hello Karen, here are some of my suggestions:

    - Start with which countries you plan to market the device in...maybe even in an order of priority.
    - Then identify these country's specific regulations that are applicable to your device.
    - Identify registration and pre-market submission requirements applicable to your device in these countries.
    - Develop a regulatory plan showing the sequential order of which regulatory components need to be in place in order to introduce the product in each country of interest. It is possible to introduce a product in one country, then do some additional regulatory work to introduce it in another country, and so on.
    - Something similar for post-market surveillance

    Thanks,

    ------------------------------
    Barry Ashar
    Makromed, Inc.
    Salem NH
    United States
    ------------------------------



  • 10.  RE: Regulatory Strategy Question

    Posted 03-Feb-2020 10:27
    Hi Karen,

    As you've already probably determined from this thread - the first thing to do is clarify what your organization wants/means by "regulatory strategy." Over the years I have seen this mean

    - approach to most quickly get to market in a single geography
    - a strategy for which markets in which order should be approached from the regulatory perspective (usually driven by timing)
    - a detailed plan of "tasks" needed to get to a submission (yeah, I know this isn't a "strategy" but not everyone understands RA)
    - a plan for initial indications and how they will morph into future indications

    etc, etc.

    Once you have clearly defined the need, you can leverage some of the great resources referenced in this thread. I do encourage you to make sure you have alignment with whoever is asking for this on what they actually want.

    g-

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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