Preparing a medical device submission requires more than compiling documents. It demands clarity, consistency, and alignment with regulatory expectations. Sobel supports manufacturers by assessing documentation and labeling readiness, helping reduce avoidable gaps before submission to Health Canada.
A regulatory submission readiness assessment helps prioritize actions before submission timelines are impacted.
A regulatory submission readiness assessment helps identify documentation and labeling gaps early, reducing avoidable review questions and resubmission cycles.
This service supports timeline protection by identifying and prioritizing corrective actions before submission.
A structured gap assessment improves submission predictability and supports more efficient interactions with Health Canada.
Sobel’s readiness services are designed to assess what already exists, highlight regulatory gaps, and guide corrections — without assuming manufacturer responsibilities.
Our experts help you review regulatory documentation and labeling, either separately or combined, depending on your submission needs:
Our experts analyze the available materials to identify potential gaps, inconsistencies, or misalignments with regulatory expectations, providing clear guidance to support document refinement and preparation for regulatory review or resubmission.
This service focuses on reviewing medical device labeling to assess alignment with Canadian regulatory expectations. Our team analyzes labeling materials to identify potential gaps that may lead to regulatory questions, supporting clearer alignment and improved submission preparedness.
RDC 848/2024 replaces RDC 546/2021 and introduces updated safety and performance requirements for medical devices, IVDs, and software. This training explains the regulation’s impact on manufacturers and importers, covering the fundamental requirements that must be met for market access in Brazil.
The European Medical Device Regulation (MDR 2017/745) represents one of the most comprehensive and complex frameworks worldwide. This training provides an overview of the MDR requirements, including classification, conformity assessment routes, technical documentation, and post-market surveillance obligations, helping companies prepare for EU compliance.
ISO 10993 is the international standard for biological evaluation, establishing how to assess biocompatibility and safety of medical devices. This training ensures that your team understands the latest updates to the standard, how to design biological evaluation plans, and how to avoid costly delays in regulatory submissions.
If you are unsure which material characterization pathway best fits your device, Sobel can help you identify the most appropriate scenario based on your device classification, available documentation, and regulatory objectives.
Regulatory submission readiness extends beyond document and label review. Sobel also supports manufacturers through complementary regulatory services:
BEP, BER and safety services supporting Health Canada submissions.
Structured and compliant documentation aligned with regulatory requirements.
Regulatory readiness reduces uncertainty. Sobel helps you identify gaps early and prepare your documentation and labeling with greater confidence before engaging in the submission process. Talk to our team and strengthen your regulatory submission readiness in Canada!
1. What is regulatory submission readiness for medical devices?
Regulatory submission readiness refers to assessing whether existing documentation and labeling are sufficiently aligned with regulatory expectations before submitting to Health Canada. The goal is to identify gaps early and reduce avoidable review issues.
2. Is this service suitable for first-time submissions and resubmissions?
Yes. Regulatory submission readiness assessments can support both initial submissions and resubmissions by identifying documentation or labeling gaps that may affect regulatory review outcomes.
3. Do these services replace the preparation of submission files?
No. These services focus on gap identification and regulatory guidance. Submission file preparation and compilation are not included.
4. Can the document gap analysis and label evaluation be contracted separately?
Yes. Each service can be contracted independently, depending on where regulatory risks are identified, or combined for a more comprehensive readiness assessment.
5. Are all device classes eligible for regulatory submission readiness services?
Yes. The services can be applied to medical devices across different risk classes, based on the documentation and labeling provided.
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