Scenario #1: You’ve spent years developing a new product and are ready for launch, however you need regulatory approval to begin marketing. So, (1) where (which countries) to go to for clearance; (2) what do I claim, relative to the products’ performance/capabilities?
Scenario #2: You have a product that is successful in one country or region (e.g. U.S. or European Union [EU]) and you’d like to expand internationally. So, (1) where are the best market opportunities for growth; (2) what are the regulatory hurdles to launch in those countries?
Scenario #3: You have legacy products in the EU that will no longer saleable there after May 2020 if they are not updated to the new Medical Device Regulations (MDR); is it worth doing so?
These scenarios all start with market opportunity (more on that in a future column), however, if there is not significant market opportunity, then the regulatory strategy for that country/region is not relevant. The key ingredients for market opportunity are market size, time to market (relative to regulatory hurdles), reimbursements, and likelihood of market adoption (which varies by region due to differences in clinical practice).
As you consider regulatory strategies around the world, the key regulatory bodies’ current dynamics include:
While there have been positive improvements in the 510K process, due to recent documentaries (i.e Netflix’s “The Bleeding Edge”) and media stories that isolate unfortunate incidents and significantly blow them out of proportion t, the FDA is seeking to crack down on predicate device practices, making it more likely that you’ll need to perform additional clinical trial testing in the future.
EU Medical Device Regulation (MDR)
The EU used to be a relatively fairly easy market to launch a medical device product. Get a CE mark and file a few country registrations, and you’re in the market. An overly burdensome new regulatory system, the MDR, is a game changer. It’s now difficult to launch in the EU in a timely manner due to the lack of available Notified Bodies to help you with your regulatory clearance.
If you do not know what Notified Bodies means – then you definitely need to find a new regulatory consultant.
Currently a positive story, Japan has realized it’s lengthy regulatory process has been a detriment to innovation coming to the country. While still not easy, the Japan Pharmaceuticals and Medical Devices Agency (PMDA) is open to a collaborative process to help you understand what is necessary for approval.
Unfortunately, China (as one of the world’s biggest markets) has gone from being one of the easiest countries to launch a product to one of the most complicated and burdensome. With standards continuously changing, even companies that operate in China don’t always understand the rules. Therefore, in all the scenarios described above, you need to be up-to-date on the current regulatory trends in the markets you operate or that you intend to launch new products. As a business leader, you’ll want to ask your regulatory team for continuous updates on these trends in each country so you can strategize your business opportunities appropriately.