Medical Device Submissions

Regulatory approval for medical devices requires a meticulous and structured approach, particularly for companies seeking global market access. At eCTD Pharma, we specialize in electronic Common Technical Document (eCTD) submissions for medical devices, ensuring compliance with MHRA, FDA, EMA, Health Canada, and other global regulatory agencies.

Navigating Medical Device Regulations with eCTD

While eCTD is traditionally associated with pharmaceuticals, it is now increasingly being used for medical device regulatory submissions—especially for combination products and device-related applications. Whether your device is classified as a standalone medical device, in vitro diagnostic (IVD), or a drug-device combination product, we ensure a fully compliant submission to the appropriate regulatory body.

Our Medical Device eCTD Submission Services

1. Regulatory Pathway Consultation & Strategy

Determine the appropriate classification and regulatory strategy based on device type and intended market.
Advise on MHRA, FDA, EMA, and other international submission requirements.
Help with Technical File (TF) and Design Dossier preparation.

2. eCTD Compilation & Publishing for Medical Devices

Complete eCTD dossier preparation in accordance with global regulatory guidelines.
Compilation of Module 1 (administrative and regional requirements), including cover letters, application forms, and device-specific regulatory documents.
Technical documentation formatting to align with eCTD requirements.
Submission of required data, including safety and performance reports, clinical evaluations, and risk management documents.

3. Life Cycle Management & Compliance Updates

Handle post-market surveillance submissions.
Manage variations, amendments, and renewals for medical devices.
Submission of Periodic Safety Update Reports (PSURs) for continued compliance.
Ensure regulatory maintenance of device approvals in multiple regions.

4. Gap Analysis for Medical Device Submissions

Before submission, our team conducts a thorough gap analysis to:

Identify any deficiencies in technical documentation that may delay approval.
Ensure clinical and safety data meet regulatory expectations.
Confirm that electronic submission requirements are fulfilled for smooth acceptance.
Provide a compliance roadmap to streamline the submission process.

Why Choose eCTD Pharma for Medical Device Submissions?

Expert regulatory team with experience in global medical device submissions.
Seamless eCTD publishing using our industry-leading software.
Comprehensive compliance support from pre-submission to post-market requirements.
Efficient and accurate gap analysis to enhance approval success rates.

At eCTD Pharma, we ensure your medical device submissions are fully compliant, efficiently prepared, and successfully accepted by regulatory authorities. Our expertise in eCTD publishing for medical devices simplifies the regulatory journey, allowing your company to focus on bringing innovative devices to market.