Activity

  • I do believe that the medical device community is progressing towards a global system of regulating medical devices. I think that as more countries get more industrialized and gain more technology, countries will “go with the flow” and adopt regulatory procedures and protocols followed by other countries to enhance quality of their products. I think that this will be beneficial because having unified system creates a level field where companies will not seek to reduce their costs by outsourcing to foreign countries to create their medical device products. In theory, having a global system of medical device regulation could help foreign countries because it will help them ensure that their companies do not cause harm by introducing harmful products to the market. I believe that the FDA already imposes too many regulations already, which is why many big pharmaceutical companies (e.g. Johnson and Johnson) do not make their drug products in the USA. If we have a global regulatory system of medical devices, it must not impose more burdensome regulations, because this would hurt many companies as device costs could rise dramatically. I agree that the European system of regulations is much more powerful than the FDA but that doesn’t mean it’s a good thing for European countries to give this much power because extreme regulations will not be beneficial.