Activity

  • 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.