I agree with you that there would be more pros to creating a universal regulation process than there would be cons. In regards to which countries would use these processes, I believe it would have to be something that were added to the United Nations list of goals. One of there goals is 'good health and well being'; so it would have to be some type of rendition to that goal. A massive con that you mentioned was time consumption if there was a globalized type of regulation process. I agree that more time would likely be consumed, as a global regulation process would be very particular to detail. However, if a global regulation process was created then the best minds of the world would be able to collaborate on how the regulation process should operate. As a consumer I would like this process because it means that I am getting the best products, due to such a strict system. As a future pursuer of industrial work I would not enjoy a global regulatory system.

While this could make it easier to globalize healthcare and allow for easier import/export of drugs and devices, I think it will make it harder to bring new products to the market in the first place. Assuming there is one global regulatory body, it will essentially adopt all of the strictest rules possible from each country involved. The US would not join this effort if it would lead to loosened requirements for safety and efficacy, that would be going counter-productive. So, every country would have to agree on these rules which could lead to outrageous requirements for new products. Then everyone would be held to the same standard of excellence, even if some manufacturers would not be able to pay for the facility quality required of other country's laws. Unfortunately, medical devices are not just judged on the finished product which you may find nice and pristine in a package. Regulatory bodies like the FDA care about the process used to make the product and even the quality of the suppliers which companies get their materials from. I just feel that each country has a vastly different perspective on how a medical device or drug should be manufactured and how that would affect its safety and efficacy.

I do not think that the medical device community as a whole is moving towards a globalization of regulatory procedures because as we have learned in lecture, the approach to regulation regarding drugs and medical devices has been a reactive process. The two examples being the Biologics Act of 1902 after a tetanus outbreak from diphtheria antitoxin, and the Food, Drug & Cosmetic Act of 1938 after people died from drinking an elixir containing antifreeze. As time goes on countries may begin to copy each other's regulatory practices, changing their regulations as they learn from another country's mistakes, but I don't think it will get to the point where there is one governing body for globalized regulatory procedures. In my opinion I believe having separate regulations for each country is beneficial because there is this pseudo-competition for each country to be the "top dog," and by reacting to another country's increase in regulation allows for the development of regulatory processes that are enough to maintain safety and efficacy without slowing down the roll out of a device due to overkill regulation.

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.

I don't see global regulation happening. When filling out the different applications with the FDA, there are application fees. If everything becomes global the application fee will change as well which I do not think will happen. Also, the level of comfort with devices and drugs are not the same globally. A great example would be the thalidomide fiasco.

For most companies in the BME industry, they operate globally. This means that they have to adhere to all of those nation's regulatory agencies. There are agencies such as EMEA, CFDA, ANVISA, etc. that come to the US to ensure regulatory compliance. Not all companies that try to sell to the US have such regulations. For the US, companies follow a sort of "de facto global regulations". This is so they can sell to the largest market possible. Will it be written into law? Probably never. However there are "global requirements" that most agencies require for companies to follow because they are common between the agencies.

I think that regulation of medical devices is approaching a global standard. As mentioned in our class discussion, much of the world's regulating bodies are catching up with each other in terms of how stringent regulations may be and the barrier to entry from those regulations. The real question is when this will happen and what will it take in order to get from the segmentation we have now to a new global standard. In a new standard that is global, some regulating bodies may have to compromise more or less than other countries' regulating bodies in order to adopt the global standard. Such a large scale process change could take decades to adopt: Europe's EUMDR is already going to take many years for companies to adapt to, and that is just one market. To change how they do enter regulations for everything will take even longer. Even so, I think companies would be on board with such a change. There are already so many hoops to jump through to go through one country's regulatory process, much less go through several different ones (US, EU, Japan, etc.) Having a standard that is recognized everywhere would streamline the process for companies and make it less of a headache in trying to translate from one regulatory body to another.

One interesting point to mention however: will every country adopt this global standard (assuming you believe a global standard will occur)? I feel it is likely that even if there is a global standard created, some countries will decide not to recognize it, or worse (depending who you ask), require that you conform to both the country's regulation and the global regulation. If a global regulation standard is created, will this mean the end of country specific regulation or would the two exist in the same time? (I think the latter). I'm interested to hear other views about this!

There are ISO standards that are used by companies for launching any medical device in any country that doesn't have their medical standards or if they are not clear enough. The countries that have their own medical regulation of medical devices prefer following them particularly in their country. There is also a part that results in non agreement in global regulatory standards because it gets an investment in the country for the cost of the approval of the medical devices when it comes to developed countries. In addition, the country itself has invested much to comeup with these standards after many man and money power that would be likely to recover from companies that need approval and sale in that country. It won't be easy to get transferred from those to new global regulations. Some of them may not agree due to superiority issues. Now thinking about the safety prospect there was seen flaws in European standards that made US FDA more reliable. In such cases having different regulatory standards are beneficial or act as a backup. However, investment of all the money, brains and datas globally may lead to a fantastic and strong regulatory standards of medical devices. But there are least chances of global regulations where countries can't even agree on each others prospective.

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ajm73 I agree with your sentiment that some countries will not recognize it. They will definitely have some of their own specified regulations. For example, most regulatory agencies as I said before have de facto standards because it's a basic requirement for all countries. I know that your sentiment is true because it's happening already! Most agencies are playing catch-up to those with the strictest regulatory boundaries. Do I believe that, for example, the United Nations will create a global regulatory body? They could try but there's no way to enforce it. Countries would have the ability to approve or not approve drugs/devices if they follow the global regulations or not! Judging by how nations have acted in the past, there either will be no global regulation or it will be in addition to country-specific regulations.

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.

I think that the world is definitely moving towards one global system for regulations of medical devices. In addition, I believe that a global system of medical device regulation will have a plethora of positive benefits on the world. For example, it would allow countries to easily utilize products and devices from others without going through another verification and testing process for regulation. The only major problem I see is one that Nicole pointed out, in that not every country has the resources to test a device in the manner that would be required for the US FDA standards.

I have always believed that the overwhelming outcome of shared resources and collaborations would lead to a positive outcome. One of the main benefits of global regulation of medical devices is that scientists and research groups in one country would arrive at conclusions that others might not see. this will result in a common good output that would be shared amongst everyone. In addition, some third world countries would greatly benefit from such globalization of medical device because they do not necessarily have the same resources to spend on testing procedures. Therefore, having these globalized regulations would provide them with results and reports that would strengthen their law and regulations. Even at the manufacturing level, manufacturers will have no choice but to follow through with the global regulations and this will make the medical device market very competitive as the local factories will realize that are international players in the market from countries like China and Japan which can build less expensive devices that would pass the regulations.