Should there be a global standard created, and countries conform to it, there will be those countries that will decide not to conform to it and go with their own standards. I would be interested in hearing some thoughts on the following: If there is a global standard in many countries and some countries decide not to adopt it, is it worth it from a company's perspective to venture into that country's market (with all the trouble of learning the new/different regulations)?
The FDA regulates food, drugs, medical devices, biologics, cosmetics and radiation emitting products in the USA. FDA Center of Devices and Radiological Health (CDRH) is responsible for regulating manufactures of medical devices. Medical devices are regulated under the Federal Food Drug& Cosmetic Act. Manufacturers importing medical devices into the USA must designate a United State agent, register the establishment, list the device, manufacture according to the quality system requirement and file a premarket notification 510(k) or a premarket approval.
As someone that currently works in a Medical Device company, I think Global Regulation of Med Devices is something that will happen in this lifetime. The reason I say that is because of money! If China is able to manufacture medical devices that are used in the US, US based companies would save a fortune on manufacturing costs! At my company, we pay manufacturing technicians/operators approximately $30/hour. Majority of their responsibility is assembly of medical devices. China can assembly these devices for less than $1/device. It is only a matter of time before large medical device companies lobby Congress to allow Global regulation to all the US based companies to profit on cheap labor! I don't think this is the way to go, because while money is important, the integrity of the medical device should be more important than the cost.
I agree that global regulation may cause major delays with testing medical devices. Given that most implantable devices cannot be tested within the US, most companies do their testing internationally where regulations are much more lenient. Majority of chemical testing is done in china, device testing in europe, most of the sales and animal testing are conducted in the US. Unless the regulation across the globe wil allow for the ability to share equa testing conditions required, there could be some benefit as well as the ability to help the respective countries' economy. However, if the regulations such as what the US enforces is made global, there will be major delays in medical device innovations.
I think globalization will help improve health care in countries with very low standards of health care .I do agree to the point that availability of resources are different in different places ,there are always challenges in doing big thing of this magnitude globally ,But that is the challenge worth taking. There are lot of companies manufacturing same product differently to sell in multiple countries .By globalizing the challenge of manufacturing products would become easier as everyone would have the same standards and help companies to concentrate their resource on other fields of research . This might affect small manufacturing companies and also might give monopoly to big companies .As lot of local companies get work from big companies in different countries would be affect as the standardization will help big companies to not be dependent on local companies .There are pros and also cons ,But I think globalizing would help change standards across the globe.
With the different regulatory systems including FDA and the Europe’s new system, there can be a globalization of regulatory procedures, but I don’t think it would be any time soon. There are many products that can be used in the USA as well as other international countries but there are many more restrictions sometimes either in the USA or internationally. There is more paperwork as well as testing involved depending on the product. It would be a beneficial factor if there was a globalization of the regulatory procedures because then there would be one process everyone would have to go through. There is a possibility of a longer approval process, but the other steps would become easier because then all the paperwork and testing would be the same. It would have everyone on the same page and the use of different products in different countries wouldn’t be an issue either.
There are far too many medical solutions which are developed in other countries which are taking years to reach the US because of the difference in regulations between all the different regulation requirements in the world. Having a global solution to regulation on medical devices would create a great global market for medical devices. That would be obviously good for the economies in the world, but also it would be great for people suffering from diseases which have breakthrough treatments in other places in the world that we have to wait to treat patients with on our side.
I do think that the world is moving towards a global medical device regulation system, especially with EU MDR. It is a hassle on companies though, changing their products so that they are compliant to the new regulation. With any changes to a system, there are benefits and consequences. With a global system, there would not have to be any issues with labeling and other shipping procedures being different depending on which countries products are being shipped to. Manufacturers and suppliers would also have to fulfill the same regulations so there would be a common ground for companies worldwide. The consequence is that it will take a few years for companies to fulfill the new standards, as they are doing with MDR. Another consequence is that if countries want to ship to the US, they would have to follow FDA regulations, which are much stricter than a majority of countries.
Having the same regulations worldwide seems to be an easy solution to launch one product across all regions/countries without spending extra time trying to meet all those different regulations, however, it is not that easy of a solution. Every region/country has regulations that comply with their way of interrupting the safety and effectiveness of the device and what documents would support the intended use for them. One of the most obvious differences in regulations is labeling requirements; some countries would require extra warning on the package to avoid often off label use in that country, as well as, adding the distribution center address for example as part of their country's regulation. Other differences can be technical. Some countries are more strict when it comes to medical devices than others, requiring more documents to support regulatory submission, i.e. requiring a full biocompatibility report instead of a memo leveraging a predicate device. All those requirements are based on the health authorities and how they define certain things like what is considered a significant change which determines if a registration is even needed or not to clear a device. Also some countries have regulations that only apply to them like testing in a higher temperature for shelf life due to the high temperature in the country (i.e. Saudi Arabia). Finally other countries only care about Class III devices in terms of submission since they are high risk devices. On the bright side, some countries can leverage the submission/registration cleared in another countries to expedite the process or to only submit a notification to the health authorities, knowing that they share most of the requirements with those other countries. With this being said, I think it is really impossible to have the same regulations worldwide, but we can always try to adopt some of those submission/registration leveraging strategy to make easier to get important devices to the market quicker.
I agree with previous posts which globalization of regulatory procedures would lead to better and safer medical devices but I believe it can cause or have some disadvantages such as: spending more time to get approval or having a long approval process also it would lead the market to be a monopoly market which can cause lots of problems in export/import or the bias distribution of medical device or drug in emergency situations, also I do not think that the medical device community is going to be globalized because each country has different regulatory procedure and …. Which they sometimes change with changes in governments and so, in my opinion, it would not happen for example we can see what happened to Paris Agreement to limit global Warming.
I believe there is almost no possibility of globalization of regulatory procedures. This is mainly because as it stands different regulatory bodies have different standards, which I know is obvious but it also very important. As it stands no regulatory body is secretive about its standards. So regulatory bodies could implement the same standards as other regulatory bodies and accept all decisions made by other regulatory bodies. But this has not been done due to countries having different environments and resource availability. For example, just because a biomedical implant is available and guaranteed safe that same implant may no longer be safe once transported or even made in another country. As such, having separate regulatory bodies in each country is actually the best way to ensure that a product used within that country is safe, assuming that the country has an effective regulatory body. As it stands globalization of regulations may make improvements in terms of market availability for products, but I believe overall it will be detrimental to patients who would actually have to face the consequences of regulatory bodies not considering all possible forms of issues arising.
I do not think the world is moving towards a global regulation system. Although a global system could potentially benefit highly developed countries with more advanced medical systems (for example, some comments discussed improving import/export of medical devices), I think it would be detrimental to less developed countries. As with any regulation system, failure to follow any guidelines or rules would result in consequences. In countries limited due to economic or other reasons, if they do not have the means to adhere to global regulations, the consequences of not following regulation standards would just continue to make the conditions in their medical systems worse. I think regulations that are not made to meet the needs and limitations of any specific region would most likely do more harm than good.
While I do think that, in theory, a global regulatory system would be great, I think in practice it would actually be less effective than having multiple regulatory systems. Look at the FDA, there are still occasionally products that, "slip through the cracks" and end up hurting people. Even if there was a massive corporation to oversee such, I feel that making such would result in a system that is more prone to errors and issues with oversight.
Along with that, regulatory laws across the world vary greatly. If a global system did exist, it would either need to be modified per country it oversaw or it would need to pass laws across the entire world (which, legislative-wise, is a complete nightmare).
If it was possible though, I think this system would be beneficial. The standardization of procedures makes them more transferable regardless of where in the world you are. For example, a product made in Europe could easily be used in the United States without further testing or FDA inspection. It could be used sooner and thus have access to a larger audience almost immediately.
I just cannot see a reality in which creating such would be possible.
In the future, I do see there being a globalization of regulatory procedures. As for whether this would be a beneficial or not, I think it will because of how it will make medical devices globally available. This is because it allows patients to receive medical devices, they otherwise wouldn’t have been able to access. The effect is an overall improvement to the global medical community as there is a larger number of tools available.
When we met with Dr. Simon in person for the introductory class a portion of the time we spoke about Europe's new regulatory system, and how it has dethroned the FDA as the "big dog." My question is, do you think that the medical community as a whole is moving towards globalization of regulatory procedures? If so, will this be beneficial or detrimental to medical device approval? I personally believe that although global regulation would lead to better and safer medical devices, globalization might add years of valuable time to the approval process. Additionally, not every nation has the same resources to equally test a product. Like anything else globalization will have its cons, but personally I see more pros to this.
As it was mentioned in the lecture about the FDA, there is a European equivalence to the FDA in Europe, which is the European Medicines Agency (EMA) and many more around the world to regulate medical devices, biologics, and drugs. I do agree with you that globalization has its pros and cons; however, I think globalization will have more cons in this case than its pros in terms of time and money. I work in a Pharmaceutical company, where we use autologous cells to make a treatment for multiple myeloma, and I have seen some European lots. In terms of manufacturing, when dealing with a European lot, we gown differently going to the clean rooms, we perform more tests, and we face more issues with the compromised cells. On the other hand, getting the EMA approval will take more time and will cost more, and that will affect the price of the medicine not only that but it will delay its commercialization in other countries if it to be globalized.
