Medical Device Regulatory affairs in the global economy is highly complex and challenging. To grow, medical devices companies must expand to new markets. Increasingly, each country’s regulations are becoming more complex, stringent and ever changing. In my current position, I manage changes from external manufacturers to devices currently on the market. Even for minor changes, we have to obtain a global regulatory assessment which can often mean going to several dozen local regulatory affiliates to determine what testing and documentation is needed to support a change. Both the regulatory assessments and the added testing/documentation can significantly impact the timeline to what should be a simple change.

Another recent example of a global regulatory challenge is when regulations change. We are currently in the process of updating worldwide certificates for all our products from Johnson and Johnson to Cardinal Health. India recently had an update to their regulation and now require real time aging for all of our products. This means in order to continue to sell or products in India (a huge market) we must invest in a 2+ year process of real time aging for dozens of products where accelerated aging was previously acceptable.

Question for discussion: What are some other examples of challenges within the area of global medical devices regulations? How can these impact project plans?