Product Registration

Seamless Regulatory Approvals for Medical Devices and IVDs

Navigating the product registration process can be complex. Each market has its own regulatory framework, classification system, and documentation expectations. An incomplete or misaligned submission can lead to major delays, increased costs, or even rejections.

At Scansio, we simplify the process. Our regulatory consultants work closely with clients to develop clear, compliant, and complete submissions—ensuring faster time to market and reducing the risk of regulatory pushback.

Our Approach to Product Registration

🔍 In-Depth Product Understanding
We thoroughly analyze your product’s technical specifications and intended use to align with applicable classification and regulatory pathways.

📊 Gap Analysis & Requirements Assessment
If needed, we conduct a comprehensive gap analysis to identify missing elements, assess data readiness, and determine if any additional studies or validations are required.

📁 Dossier Preparation & Documentation Management
We manage and compile submission-ready documents in formats such as CTD/eCTD, ensuring they meet current regulatory standards—including those related to quality systems, manufacturer accreditation, and product safety.

📝 Application Submission & Communication Handling
Our experts handle all communications with regulatory bodies, addressing inquiries, attending meetings (as needed), and managing post-submission correspondence.

✅ Approval & Certification Support
We oversee the registration process through to final approval, delivering official certification and supporting post-approval compliance and lifecycle documentation.

Why Choose Scansio for Product Registration?

  • Proven expertise in medical device and IVD registrations
  • Deep understanding of submission frameworks and classification protocols
  • Full lifecycle support—from pre-submission to post-approval
  • Strategic, efficient, and compliant registration solutions

Get Your Product Approved—Faster and Smarter
Let us help you reduce uncertainty and speed up the path to market. Reach out to the Scansio team today to explore your product registration needs.