When exporting medical devices to other countries, how much does a report stating that the product has passed clinical trials in the previous country affect clinical trials in the country where they are exporting?
I feel like this will depend heavily on how the standards and regulations compare between the two countries. For example, since the European Union has a specific set of regulations it is easier to export a product from one EU country to another than it is to import lets say from China into an EU country that may have very different levels of standards to go through.
It's definitely trickier because outside countries have much different regulations than the US or wherever the medical device originates from. There may even have to be a redesign of the project or at least further clinical trials to allow the device to be exported. This is an interesting scenario that I think most of us haven't thought about. I would think a company would have to weigh the options of opening up their market globally, yet possibly having to delay a project timeline if they wish to sell the device in another country.
This depends on the rules and regulations of the country where the medical device is being exported to. Some countries run more extensive and rigorous clinical trials than others, and this may lead to a complete redesign of the medical device. Companies must take this factor into account before beginning the exportation process to ensure that the device passes clinical trials so that the company may begin to sell the product without significant delays.
As others have mentioned it would vary for each country/region. I imagine it would look good for a product to have promising results in the US for example when marketing in the EU, however the tests required in the US may not encompass all the tests needed in the EU. So while in an unofficial view it may be nice to see, each regulatory body will set their own standards for what they deem acceptable for their citizens. This means that portions of clinical testing may need to be repeated to match the additional country's standards.
It can be tricky to export medical device to other countries under one clinical trial umbrella. This is due to the many different regulations and standards used in different countries (i.e. EU Standards, Chinese Standards, etc.). It is important to do background research if it is defined during the project that there is an intention to sell/use these devices in multiple companies. These differences in regulations can be solved by taking in account all of these different regulations when designing the clinical trials. That way the data from the clinical trial(s) can be leveraged for applications to the different countries regulatory agencies.