Medical device manufacturers know the woes of getting your product through the FDA process and onto the market. Even for seasoned professionals, the regulatory process can sometimes be daunting or unclear. Although there are regulatory horror stories out there, it is important to remember that once you have received clearance or approval for your product it makes the whole process worth it. But how hard is it to expand the market for your device beyond the United States?
Like everything, what you will have to do in terms of workload and resources to expand your product into international markets depends on a lot of factors. My first suggestion to any medical device firm looking to expand internationally is to nail down what countries you want to sell your product in. I have seen plenty of cautionary tales of eager firms listing out a handful of target markets, only to get knee-deep into the process and realize they do not have the resources (financial or human) to complete it. This is typically after they have already spent most of their annual budget on the effort. It is always best to fully think out which markets you want to expand in, how it will benefit your business, and have a targeted plan.
Once you have determined what your target markets are, now comes the time to research the regulatory requirements for those countries. The first thing you should do is understand what government agency regulates your product, which will feed into understanding what regulations you must follow. It is important to note here that you should not assume that the regulations globally will be the same or even similar. Even for our sister country to the north, Canada, the regulations have nuanced differences. For example, if you have a Class II or higher product, you will have to go through MDSAP certification before marketing your device in Canada.1 Additionally, the workload may vary from country to country. There will likely be more research required for niche markets like Malaysia, for example, than Canada or the EU. Therefore, it is crucial to truly understand what your target markets are before beginning the endeavor.
It is always best to make sure you have regulatory experts on your team before expanding your product into other markets. It is important that you have a team that not only knows the varying regulatory requirements but can help you implement them effectively. At EMMA International we have helped several clients expand into other markets successfully by working alongside their team to do the regulatory heavy lifting. If you need help globalizing your product, give us a call at 248-987-4497 or email info@emmainternational.com to get connected with us today!
1Health Canada (Nov 2018) Requirements in the Recognition Process for Medical Device Single Audit Program (MDSAP) Auditing Organizations retrieved on 03/15/2021 from: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/quality-systems-13485/requirements-recognition-process-mdsap-auditing-organizations-profile/guidance-document.html#1.2
