As the saying goes, time is money, and this statement could not be more true for the medical device industry. Each day that passes when a device is not approved for marketing is a day of revenue loss. Sadly, it is also a day when patients will not be able to benefit from the device.
Individual country registrations can be challenging. In many cases, it is not as simple as gathering existing documents and transferring them to the country representative. Each country has its own set of registration rules, requirements, and deadlines.
Numerous countries, for instance, demand that a device be authorized for the market in the United States or the European Union and have post-market surveillance data before beginning registration. Some countries have no regulations, but that list is getting shorter.
Image Credit: DSI, a PLG Company
When it comes to medical device regulatory strategy, three major factors can lead to delays in acquiring approval to market in any country. They are as follows:
- Document and testing strategy
- Submission strategy
- Country strategy
Document and testing strategy
The sooner that Regulatory becomes involved in a project, the more effective it will be. This is because it is a good regulatory professional’s job is to first determine the classification of the device for all countries in which they plan to market it. The form of submission required is then determined.
Then, the Regulatory professional can determine the required documents for submission as well as all of the requirements that apply to the device and Quality System. This will ensure that the proper testing is in place and that the objective evidence (ex. Protocols and Reports) that will go into a submission/registration is being created.
Nobody wants to have to re-test a device as a result of the incorrect standard or variant of the standard being used. In addition, no one wants to perform testing while under agency review because a government agency has asked for additional testing.
Submission strategy
Even though most submissions include instructions on how to put it together, what topics should be covered, and how to finalize the file for review, several other methods can be used.
Examples include:
- How does one choose a Notified Body that is a good partner?
- Can it be justified not to do certain testing?
- Can it be justified not to have used the newest version of a standard?
- When is the best time to submit it?
- Can the data be used from an equivalent device instead of doing new testing?
- How many or what type of changes are too many for a Special 510(k)?
- Is there a requirement for Pre-Sub?
Making a plan will help meet all of the deadlines. Target dates are essential because the submission influences the date of prospective market approval.
Country strategy
- Where can the device be advertised right now? Two years from now? Five years from now?
- What country should the user get the initial marketing approval in? How long will it take? How much will it cost?
- How can one 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 registering 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 aforementioned questions, as well as many others, can be answered by a Regulatory professional at the start of a project, so users have all the information that they need to make choices that makes sense for the company and allow them to plan to meet its goals and target dates.
A seasoned Regulatory professional has the resources and understanding of what is going on around the world, which can save a company time and money throughout the project. If the project requires a seasoned Regulatory professional, contact DSI today.
About DS InPharmatics
DS InPharmatics (DSI) provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.
Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence. Whether advocating CMC strategy, directing CMC operations or developing CMC submission content that represent the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.
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