Electronic Submissions for Faster Medical Device Approval

The procedure of registering and getting a medical device (MD) approved can be lengthy, complicated, and time-intensive. From preparing a dossier to satisfying multiple regulatory authorities and everything else in between, traditional submission practices can be subject to delays and potential human errors. Medical device manufacturers now have a rapid and efficient way to obtain regulatory approval through the emergence of electronic submissions.

Electronic submissions (e-submissions) refer to situations in which authorities such as the FDA, EMA or national regulatory bodies receive all necessary regulatory documentation through electronic platforms. By utilising electronic submissions, medical device manufacturers can simplify the approval process, mitigate potential errors associated with human intervention, and track regulatory submissions more accurately.

Benefits of Electronic Submissions

1. Quicker Processing Time

The traditional method of submitting documents on paper usually means you might have to send them by mail or courier service, and then wait multiple rounds of interaction with a regulatory authority before obtaining a resolution. When you submit documents electronically, this interaction can go away because you simply upload a document, and the agency can review and comment on the document through a secure online portal. This reduces the overall time to market.

 2. Reduce Mistakes and Improve Accuracy

When you submit paper documents, there is a chance for human error; for example, the document may be missing a signature, a page may have been left out, or documents may even be illegible. These human errors are why regulators will reject a submission, or it may hit a pause in the review. Digital submissions utilise structured templates and validation measures to ensure all required fields have been completed correctly before submission. Doing this will reduce an agency’s risk for compliance and its chance for first-time approval for your submission.

3. Cost Savings

While e-submission might have some setup costs, the savings begin to pay off over time. As manufacturers are no longer printing materials, couriering documents, and spending manual labour time, the costs are significantly lower when an e-submission program is used. Additionally, if approvals take considerably less time, products can be on the market quicker and start earning revenue and avoid costs associated with missed opportunities.

4. Better Tracking and Record-Keeping

Because these documents are electronically submitted, manufacturers are able to easily track submission status in real time. The manufacturer will know the status of the review, will receive alerts if further clarifications to the submission are necessary, and the submission record can easily remain in order in these electronic submissions. Not only does this support straightforward audits, but it also supports compliance.

5. Global Compliance Made Simpler

Many countries now accept, and even prefer, electronic submissions for medical MD registration. Digital platforms help manufacturers standardise submissions across many regulations and prepare for approvals across multiple jurisdictions. This can assist with consistency and compliance under FDA 21 CFR Part 11, EU MDR, or Health Canada and other regulations.

How Electronic Submission Works

Digital Submission Preparation

All technical dossiers, quality systems documents, risk assessments, and labelling were converted to electronic formats; a typical standard would be eCTD (electronic common technical document) or PDF.

Submission Platforms

Regulatory agencies provide online sites for manufacturers to upload their documents. These sites typically have automatic validation checks, version control, and/or secure messaging. 

Secondary Automated Validation and Review

Most platforms have automated validations to check submissions for missing information or formatting. Automation mitigates the chance of rejection due to administrative error and helps to ensure smoother communication with regulators.

Regulatory Feedback and Approval

The authority reviews the submission online, may require additional information, and/or provide feedback. Electronic submissions allow for quick responses, tracking changes, and tracking correspondence efficiently.

Best Practices for Electronic Submissions

• Utilise Organised Templates: If you want to be less prone to making mistakes, it would be a good idea to use the templates that the regulatory agency has suggested. 

• Keep Your Documents Updated: When submitting, it is of utmost importance to see if the technical and quality documents are still applicable and updated. 
• Preparation of documents for uploading: Ensure that the documents are in the correct format, have all the required signatures, and are complete so that there will be no waiting times. 
• Employ Cloud Platforms: Secure cloud storage offers the team a means of collaborating and access to documents when required.
• Retain audit trails: Keep a log of the documents and submissions, which ultimately support audit and regulatory inspection processes.

Why Are Manufacturers Looking to Move to E-Submissions? 

Essentially, it might not be a big surprise that medical device companies are increasingly realising that one of the most important factors for them to stay competitive in both healthcare and regulatory environments is speed and efficiency. In fact, the mere act of employing an e-submission approach would in itself accelerate the whole time frame for approvals, but at the same time would be very beneficial for the rest of the elements, such as conformity, elimination of mistakes, saving of money, and so on. 

As regulatory agencies across the globe are leveling up their standards, there is a global push towards e-submissions being the new standard for medical device registration.

Conclusion

Transitioning to electronic submissions marks a fundamental shift within medical device submissions. Manufacturers save time, enhance accuracy, improve trackability, and are able to comply globally while going electronic. For medical device innovators, electronic submission platforms are not an option; they are now a strategic imperative to remain innovative and insightful within a more regulated and competitive industry.