Electronic submission of regulatory documents has become the norm in the medical device sector. Both the US Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) have introduced electronic systems. This article compares them.
The systems
- FDA – eCopy: an electronic copy of a submission, originally the electronic counterpart of the paper copy. Historically sent on CD, DVD or USB drive, it can now also be uploaded via the CDRH Portal.
- FDA – eSTAR: the electronic Submission Template And Resource is a structured, dynamic PDF template. It automates form building and auto-fills content, is aligned with the internal review templates of FDA’s Center for Devices and Radiological Health (CDRH), integrates guidance documents and databases, and includes instructions and automatic verification.
- NMPA – eRPS: the electronic Regulatory Product Submission system is the NMPA’s platform for medical device registration applications. Applicants upload the electronic version of their dossier there.
Similarities
- Purpose: eCopy, eSTAR and eRPS all enable electronic submission of medical device applications, improving review efficiency and streamlining approval.
- Functions: all three support electronic storage and transmission of application documents. eSTAR provides a dedicated template guiding applicants through the content; eRPS likewise provides submission templates and specifications.
- Use: all three are essential for premarket applications – product information, technical documentation and clinical data, which regulators use to assess safety and effectiveness, are submitted through them.
Differences
1. Scope and mandatory use
- eCopy: required for many FDA medical device submissions (e.g. PMA, IDE, Q-Submissions) that are not submitted via eSTAR.
- eSTAR: mandatory for 510(k) submissions since 1 October 2023 (unless exempted) and for De Novo requests since 1 October 2025; voluntary for certain other submission types.
- eRPS: covers device registration and other NMPA regulatory applications; virtually all NMPA device applications must be submitted through it.
2. Functions
- eCopy: electronic storage and transmission only – no templates, guidance or validation.
- eSTAR: automation (form building, auto-fill), alignment with CDRH review templates, automatic verification, integrated guidance and detailed instructions.
- eRPS: templates and specifications with some prompts and guidance, but without eSTAR’s level of automation, alignment with internal review templates or integration of guidance documents in a single template.
3. Submission routes
- eCopy: via the CDRH Portal or by sending storage media to FDA’s Document Control Center.
- eSTAR: download the template from the FDA website, complete it and submit it online via the CDRH Portal (or on storage media to the Document Control Center).
- eRPS: log in to the NMPA electronic submission system, complete the online forms and upload documents in the required format – no physical media needed.
How EVERBIZ can help
EVERBIZ draws on extensive experience in quality systems and product registration and supports manufacturers with FDA and NMPA submissions. Contact us.
This article is for general information only and does not constitute legal advice. Current FDA and NMPA requirements are authoritative.