Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
MedEnvoy Global
The Hague, Netherlands, London, United Kingdom, United States, Switzerland, Australia
A global regulatory compliance partner specializing in in-country representation (EC Rep, UKRP, CH Rep, US Agent) and independent importer services for medical device and IVD manufacturers. We help companies navigate complex regulations in Europe, the UK, Switzerland, and the US while maintaining supply chain flexibility.
ARQon Pte. Ltd.
Singapore (HQ), Malaysia, Vietnam, Indonesia, Philippines, Thailand, Taiwan, Hong Kong, South Korea, Switzerland, USA, Australia, New Zealand, Rwanda, India, Sri Lanka
We are a premier regulatory consultancy firm specializing in medical devices, in-vitro diagnostics (IVD), and pharmaceuticals. Founded in 2014, the company offers a comprehensive suite of services ranging from product development strategy and clinical trials to product registration and post-market surveillance. With a team of experts possessing vast experience in regulatory authorities and industry, we bridge the gap between scientific innovation and regulatory compliance, ensuring patient safety while fostering medical advancement. The company also provides unique business matching services through its ATTOPOLIS platform and training through the International Medical Device School.
December 7, 2025
Approximately 5 minutes
FDA Modernizes Medical Device Submissions: Key Updates to the eCopy Guidance
FDA Modernizes Medical Device Submissions: Key Updates to the eCopy Guidance
The FDA has released an updated version of its guidance, "eCopy Program for Medical Device Submissions," representing the first meaningful refresh of these standards since 2020. This update is a clear signal of the agency's shift toward modernized, fully electronic review processes.
Shift Toward Electronic Modernization
The 2024 update aligns the eCopy program with the broader eSTAR and structured eSubmission initiatives. While eCopy remains a vital part of the submission landscape, the FDA is creating clearer distinctions between legacy formats and the structured electronic submissions of the future.
Key Changes and Technical Updates
The revised guidance introduces several critical changes that manufacturers must implement to ensure their submissions are accepted by the Document Control Center (DCC):
1. Standalone eCopy Requirements
The FDA now places a stronger emphasis on ensuring that each eCopy is a complete, standalone entity. Each submission must contain only the content relevant to that specific application. Including unrelated files or referencing external structures within the eCopy is a common administrative error that can lead to rejection.
2. Modernized Technical Specifications
Technical requirements have been refreshed to reflect current technology standards:
- PDF Compatibility: Updated rules on acceptable PDF versions and settings.
- Media Specifications: Revised guidance on physical media formats and file naming conventions.
- File Formats: Clearer instructions on which non-PDF file types are acceptable for specific data sets.
3. Validation and Review Clock
To avoid delays in the start of the official review clock, the FDA has renewed its emphasis on the eCopy Validation Module. Submissions that fail technical validation at the DCC will not be moved forward for substantive review, potentially costing manufacturers weeks of development time.
Conclusion for Manufacturers
This update serves as a reminder that the FDA's administrative requirements are becoming more stringent as they move toward digital integration. Manufacturers should download the latest validation tools and update their internal regulatory publishing SOPs to align with these 2024 standards.
Ensuring a technically perfect eCopy is the first step toward a successful and timely FDA clearance or approval.