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  • I don’t think the medical device community is moving towards globalization of regulatory procedures but in future, an optional global standard must exist.
    Each country has its own set of regulatory standards for device manufacturers, I agree with @mattie718 on the point that globalization of regulatory standards will have strict requirements of new products and some companies won’t be able to afford it.
    Small companies and start-ups which do not have enough funds would be at the loss take for example they don’t want to market the device other than their own country but still, they would need to follow the strict global standard to put their device in the market.
    At the same time, global companies will benefit from the globalization of standards since they want to market their device across the globe and hence they won’t have to go through the hassle of modifying the device to match the standards of every country they wish to market.
    I feel globalization is a step in the right direction but the regulatory standards for each country should not be scrapped specifically for small companies/startups who don’t have the funds and human resources to market the device across the globe and would hence standards specific to the country they wish to market should exist.
    Also for global manufacturers, global standards should be there which will allow them the freedom to market anywhere they want to with ease.