You've likely heard the phrase “time is money.” No other statement could be more accurate for the medical device industry. Each day your company is not approved to market your device is not only a day of lost revenue, but a day patients don’t get to benefit from the value of your device.
Individual country registrations can also be very difficult to obtain. Each country has unique registration regulations, requirements, and timelines. For example, many countries require a device to have been approved for market in the United States or Europe with 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 strategies can cause delays in obtaining approval to market in any country. They are:
- Document and Testing Strategy
- Submission Strategy
- Country Strategy
Document and Testing Strategy
The earlier your regulatory team gets involved with your project, the more successful it will be. Quality regulatory professionals identify the classification of your device for each country where it will be available. Next follows a determination of the type of submission required. Then, your regulatory professional will identify the proper documents needed for submission and identify all the standards that apply to your device and quality system. This will ensure you are doing the proper testing and creating objective evidence, like protocols and reports, that will go into your submission and registration.
Submission Strategy
Even though most submissions contain compilation guidance, the topics needed for discussion, how your company submits the file for review and other factors come into play. These factors can include how a company selects a Notified Body partner. Your company may be asking whether it can justify avoiding certain testing, which standards should be used, the best timing for submission, and more. Creating a plan helps ensure you meet all target dates, which will help ensure your submission is approved in line with your launch date.
Country Strategy
In order to successfully prepare your device for market, your company should be asking where your company intends to market its device, the country where you should obtain your initial marketing approval and how to prepare for those approvals, how to prepare for country-specific regulations and registrations, and more.
Hiring a seasoned regulatory professional, like one of our expert consultants, at the beginning of your company's next project will help it gather the information needed to make the right decisions to guarantee your product is approved and available on the market in a timely manner.
