Oh No! How to recover lost medical device certificates

By
Karen Cohn
-
July 22, 2022
Oh No! How to recover lost medical device certificates

Imagine that you have started working in a new position at a medtech company, and you’re trying to organize your current knowledge of the products, registrations, and information now under your charge. However, something feels off, and you realize that you cannot find all of your company’s current medical device certificates.    

Lost medical device certificates are a more frequent occurrence in our industry. In fact, it’s my experience with the frustration of recovering lost medical device certificates that finds me writing this brief post about what it’s like to lose a medical device certificate and the strategies I’ve used to recover the lost information. We’ll even discuss what you can do to prevent having to live “The Tales of the Lost Document” in the future. 

How do certificates get lost?

The most common factor in misplaced or lost certificates is human error stemming from lax filing systems with disjointed practices and team member departures. Many large medtech companies have a complex structure of emails and document storage sites (such as Sharepoint or Dropbox). These storage sites are often siloed, with different regulatory teams having varying excel spreadsheets, folder structures, and naming conventions to organize their regulatory submission workload. 

In many companies, managing global medical device certificate information is a manual and burdensome process. The problem could be as simple as a file-naming mixup, or it could be a document your company hasn’t needed the certificate in so long that they simply lost track of it. Now let's talk about ways you can recover your lost certificates or information that’s missing from them.

How can you recover lost certificates?

The good news is that you can recover your lost documents in many cases, though it may take a bit of legwork. There are two primary strategies for finding lost medical device certificate information, and utilizing both is the best way to ensure you recover your lost certificates and information. 

The first and often most successful pathway is to search through your internal resources. 

Strategies for Searching through internal resources:

  • Have you found every Sharepoint site used in the past five years?
  • Have you checked previously recorded submissions of that medical device?
  • Have you contacted IT to see if they can recover emails from a departed colleague? They might have sent emails with the certificate attached to them. Many regulatory professionals email a copy of the certificate to announce to the marketing teams they can begin product sales.  
  • Are you working with a distributor? Contact them and request knowledge on all of the current medical device certificates. 

Other channels are available if you can’t find what you’re looking for in your company’s local storage. 

The second strategy is to use governmental medical device registration databases. For example, if you’re registration information for a class 2 medical device, you could look it up in the FDA 510(k) database. Here are some examples of the international regulatory databases that may help in your situation: 

United States - FDA

Canada - Health Canada

European Union

Australia

Belgium

Brazil -  ANVISA

Singapore - Health Sciences Authority

Saudi Arabia - SFDA

If you are looking for a certificate that was approved by a notified body and not in a current database, you can contact the notified body, but you should expect to pay a fee for their services. It’s also important to note that not all countries and regulatory bodies have a database that allows companies to look up their certificates. 

You may also have to accept that you can’t recover your medical device certificate or information. Not every country has a medical device database, and even those with a database often don’t contain the certificate itself. That’s why it’s critical to the efficacy of your RA operations that your team has the tools necessary to store, track, and share regulatory information and documents securely and efficiently. 

How do you make sure this never happens again?

We understand that trying to find missing certificates is an administratively heavy burden. When you can’t find a certificate or its missing information, there’s no way to tell whether it’s lost forever until you’ve exhausted all possibilities and channels, which is why it’s much better to prevent losing documents altogether. 

With the right tools, your RA team can store, locate, and share documents in a secure and largely automated environment. That means no more awkward conversations where you have to tell your boss you can’t find the expiring certificate for your company’s flagship medical device. 

Rimsys is regulatory information management (RIM) software created by RA professionals from the medtech industry with RA professionals in mind. It empowers RA teams to store and track all certificates by product and country and even provides a portal where you can see all of your regulatory documents in a centralized view. Furthermore, you’ll receive emails when a certificate is about to expire, allowing you to act in ample time to prevent lapses in compliance and continue market access per your company’s global device strategy. 

Learn more about how a RIM system can help your organization keep track of all its regulatory information in our “RIM Buyer’s Guide.”


Karen Cohn is a Regulatory Specialist at Rimsys Regulatory Management Software. With a passion for new and emerging regulations, Karen has focused on improvements in international submission processes, regulatory intelligence, MDSAP audit preparedness and managing regulatory compliance projects for the NMPA, HSA, MFDS, ANVISA and other major international regulatory bodies. Prior to joining Rimsys, she was a regulatory specialist at Philips and helped to drive a corporate-wide program to streamline international submission processes to reduce the time to market.

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