You have heard the phrase “time is money.” No other statement can be more accurate for the medical device industry than this one. Every day you are not approved to market your device is a day of lost revenue. But unfortunately, it is also a day that patients don’t get to benefit from your device.
Individual country registrations can be very difficult. In many instances, it’s not simply obtaining documents you already have and sending them off to the country representative. Each country has its unique registration regulations, requirements, and timelines. For example, many countries require that a device has already been approved for market in the USA or EU and has post-market surveillance data before starting registration. Some countries have no regulations, but that list is getting smaller and smaller.
When we are speaking about regulatory strategy for medical devices, three major areas can cause delays in obtaining approval to market in any country. They are:
The earlier you get Regulatory involved with your project, the more successful you will be. Why is that? The job of a good regulatory professional is to first identify the classification of your device for all countries you intend to market. Next is a determination of the type of submission required. Then your Regulatory professional can identify the proper documents you will need for your submission and identify all the standards that apply to your device and your Quality System. This will ensure you are doing the proper testing and creating the objective evidence (ex. Protocols and Reports) that will go into your submission/registration. No one wants to re-test their device because they used the wrong standard or version of the standard. And no one wants to try to get testing performed while under agency review because a government agency has requested additional testing.
Even though most submissions have guidance that tells you how to compile it, what topics need to be discussed and how you submit the file for review, many other strategies come into play. Such as: How do you choose a Notified Body that is a good partner for you? Can you justify not doing certain testing? Can you justify not having used the most recent version of a standard? When is the best time to submit? (Note: it’s not two weeks before Christmas). Can you use data from an equivalent device instead of doing new testing? How many or what type of changes are too many for a Special 510(k)? Should we do a Pre-Sub? Creating a plan helps ensure you meet all target dates. Target dates are important because your submission affects the date of potential approval to market.
Where do you intend to market your device right now? Two years from now? Five years from now? What country should you get your initial marketing approval from? How long will it take? How much will it cost? How can you be prepared for additional registrations/marketing approvals, after the initial approval, without revising or creating new documents? What are the timelines? Which countries require their clinical study or device samples sent to their testing lab? Which countries require you to register through an in-country distributor? Which languages must the labeling be translated to? Which countries are considering or are in the process of creating new regulations?
The above questions, and many others, can be handled by your Regulatory professional at the beginning of a project, so you have all the information you need to make decisions that make sense for your company and offer you the opportunity to plan to meet your goals and target dates.
A seasoned Regulatory professional has the resources and knowledge of what is happening worldwide and can save a company time and money throughout a project. Talk to DSI if your project needs a seasoned Regulatory professional!