Regulatory agencies across the globe are evolving in terms of device regulations. Hence, it’s becoming imperative that agencies start switching from the paper submissions to e-submissions. This transition becomes critical as the number of submissions, as well as approvals increase every year. Additionally, every device is unique with its own sets of requirements, in terms of data and documentation, due to which it also becomes challenging to really adopt for the e-submissions.
As this transition becomes eminent, more focus would be on how well the guidelines are established by the agencies across the globe along with setting up templates and requirements. From the manufacturer’s perspective, the compilation and publishing of the device specific technical file becomes critical, as it has to fulfil the requirements of the General Safety and Performance Requirements (GSPR) and are structured as per the Health Authority requirements. This shall also include transfer and retention of the technical files in the electronic or hard copy, either with the authorized representative or manufacturer.
Regulatory agency like, the US FDA has already established the submission requirements for eCopy generation and submission of the device technical files for below submission types, among which for some it is mandatory, while for other submissions it is voluntary.
- 510(k) submissions, including Third Party 510(k) submission
- De Novo Submissions
- PMAs, including Transitional PMAs
- INDs (Combination products)
- BLAs and associated amendments (Combination products)
- CLIA submissions (CRs and CWs)
- 513(g) submission
- Expert review of the technical file to ensure all the essential requirements are met
- Creation of the e-Copy/electronic folder structure
- Creation of the regional documents and tagging of files
- Insertion of all appropriate document and submission documents along with bookmarking and external hyperlinking followed by compilation, publishing, and validation
- Performing Document Level Publishing (DLP) including bookmarking, internal hyperlinking, word to PDF conversion, scanned document to readable format and make them submission ready documents for e-Copy publishing
- Performing required quality checks as per country specific Regulatory standards before submissions
- Finishing activities include those activities associated with the creation of region/ country specific application versions and may include creation of electronic submission, burning CDs and binding
- Structured solutions and support for e-copy preparation and submission of technical files
- Support for all risk class devices and required submission types
- Continuous support to the product, throughout its Lifecycle
- Delivery mechanisms to provide Regulatory submissions to local Regulatory subsidiaries, agencies worldwide, and internal customers