The new article describes in detail the authority’s review process when assessing applications related to medical devices.
Table of Contents
Health Canada, the Canadian regulating authority in healthcare products, has published a guidance document dedicated to managing applications for medical device licenses.
The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance to it.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations.
Moreover, the authority also reserves the right to change the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect the corresponding amendments to the underlying legislation.
In particular, this document outlines the comprehensive process for the application and review of medical device licenses, including the procedural steps, targets for review completion, and potential outcomes following the review.
The document is intended to guide manufacturers through the administrative requirements, review phases, and subsequent actions in the event of clarification requests, additional information requests, refusals, and withdrawals.
Administrative Processing
The existing legislation provides a three-day administrative processing period for all applications. During this phase, regulatory decision letters or licenses are prepared for issuance to manufacturers, marking the initiation of the application process.
Review Process
Once an application receives a Screening Acceptance Letter, it progresses into the review queue of the Device Evaluation Division. Division Managers are tasked with workload management and assignment, ensuring compliance with the relevant performance targets.
Following the applicable legislation, the review duration is sixty calendar days for Class III applications and amendments, and seventy-five calendar days for Class IV, including the initial administrative processing period. Full fees are applied upon the issuance of a Screening Acceptance Letter.
Clarification and Additional Information Requests
During the review, manufacturers might be prompted via email for clarification or additional details to minor aspects of their submission without halting the review clock, responded are submitted within two days and deemed acceptable.
At the same time, significant deficiencies may lead to Additional Information (AI) Letters, pausing the review clock until the requested information is furnished within sixty days.
The issuance of AI letters is capped, with some exceptions, to ensure efficiency in the review process.
However, the authority might use this mechanism should it determine that the information provided by the applicant is insufficient for processing the application.
Outcomes of the Review Process
According to the guidance, upon completion of the application review, the authority takes one of the following decisions, issuing a corresponding letter:
- Refusal Letters: Issued for non-compliance or incomplete responses, outlining specific reasons for refusal. However, manufacturers can re-file applications, treating them as new, mainly if resubmission occurs within six months, allowing cross-referencing to the original application.
- Withdrawal Letters: Allows manufacturers to retract their application anytime during the review, with the possibility of refiling as a new application, maintaining the option to cross-reference previously submitted data if done within six months.
- Reviewer’s Reports and Unsolicited Information: Post-refusal, applicants can request reviewers’ reports for insight. Additionally, manufacturers are encouraged to provide updated safety and regulatory status information during the review.
Re-Filed Applications
Re-filed applications, either after withdrawal or refusal, are treated as new, adhering to current policies and procedures.
A re-filing within six months permits cross-referencing to the original submission, while those after six months or rejected applications must start anew, with total fees applied.
Fees and Review Clock Management
The document also details the fee structure for applications and re-filings, emphasizing total application fees upon specific outcomes.
It also introduces the “pause the clock” mechanism, allowing for review suspension under specific conditions to ensure fairness and thorough evaluation.
Opportunity to be Heard Process
As explained by the authority, manufacturers have the right to appeal decisions through a structured process involving initial reconsideration by the Bureau Director and a potential appeal to the Director General, possibly leading to the formation of an Appeal Committee.
This process ensures manufacturers can present their cases and seek a fair review of decisions, with the possibility of resuming the application review upon favorable appeal outcomes.
Conclusion
The present guidance document serves as a comprehensive manual for manufacturers navigating the medical device license application and review process. It emphasises the Directorate’s commitment to transparency, fairness, and efficiency, ensuring that medical devices entering the market meet stringent regulatory standards for safety and efficacy.
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