Innovation in the medical device area can be disruptive or incremental. The optimum regulatory strategy will require specific approaches for each case and in each market you intend to enter. In addition, global regulatory bodies are increasing their scrutiny to ensure patient safety and the days of US or EU approval alone opening access to all other countries no longer exists. With longer times to market in the US and EU, it is increasingly challenging to get the return on investment in established markets alone. As demand grows in established markets due to more people expecting better treatments, this still forces companies to look at these markets and secure the devices availability. In parallel, companies should be looking at emerging markets from Day 1 to improve revenue globally. This can allow for accelerated product development and a growing portfolio of registered devices to add value to your company and increase your bottom line.
Global requirements need to be reviewed and discussed to highlight key areas of concern and identify similarities to be leveraged, as well as differences to be anticipated to avoid last minute gaps.
Preclinical and Clinical evaluations for medical devices tend to be harmonized now worldwide but still some local specificities should be anticipated. Cultural and historical characteristics still influence the regulatory agencies in their reviews. Since 2014, acceleration of harmonization worldwide is visible and will continue until reaching a steady state so manufacturers may integrate those increasing demands in their timing and resources.
Despite some local specificity that still exists, harmonization in regulatory requirements is in progress. Hence, manufacturers clearly need to make sure all requirements are known and anticipated to avoid last minute delays, and also better forecast resources needed for global marketing, and refine the return-on-investment the regulatory submissions generate.
You can learn more about re-emerging and emerging market regulatory navigation during Dr. Vincent Legay’s presentation at Meet The Experts-Implants. Please contact us if you would like to set up a meeting with Dr. Legay during this conference.
To learn more about NAMSA’s regulatory services, please visit our services page.