
Overview
Health Canada Makes Clinical Information on Medical Devices Publicly in a significant move toward greater transparency in healthcare, Health Canada (HC), the country’s medical device regulator, has announced that clinical information submitted in support of medical device applications is now publicly available. This development marks a crucial step in empowering healthcare professionals, researchers, and the general public with access to critical data.
Introduction
The public release of Clinical Information Initiative in 2019, HC, began a phased approach to publish clinical information submitted by drug manufacturers and medical device manufacturers in support of Class III and IV Medical Device Licenses (MDL). In 2021, HC began proactively publishing the clinical information for new submissions. The clinical information includes tests and trials that were performed on medical devices to evaluate their safety and efficacy.
The publication of clinical information under the Public Release of Clinical Information (PRCI) initiative proceeds through five distinct phases: initiation, submission, review, finalization and publication.
HC aims to upload the clinical information package onto HC’s clinical information portal within 120 calendar days from initiation process.
What Does This Mean for Stakeholders
The new initiative ensures that clinical data provided during the medical device application process is accessible through HC’s online portal. This shift aligns with global trends emphasizing openness and accountability in healthcare regulation.
Benefits for Healthcare Professionals
Medical practitioners can now access detailed clinical information to better understand the safety, efficacy, and performance of medical devices. This transparency aids in informed decision-making and enhances patient care.
Empowering Researchers and Innovators
Researchers stand to benefit immensely, as this data can inform studies, foster innovation, and promote advancements in medical technology. The availability of this information also levels the playing field, allowing smaller entities to access insights previously restricted to large organizations.
Greater Public Trust
For patients and the general public, this move enhances trust in the regulatory process. By making the clinical evaluation data available, HC demonstrates its commitment to ensuring that approvals are based on robust scientific evidence.
How to Access the Information
The clinical data can be accessed via the Health Canada portal, which has been designed to provide easy navigation and search functionalities. Users can explore information about various medical devices, including their intended use, clinical trials, and safety assessments.
A Step Toward Global Harmonization
This initiative positions Canada alongside other global leaders, such as the European Union and the United States, which have also adopted measures to increase transparency in medical device regulation. By sharing clinical data, Health Canada contributes to a global culture of openness and collaboration in healthcare.
Negative Regulatory Decisions to Be Published as Well
When an MDL application is found to be non-compliant with the Medical Devices Regulation (MDR) and the manufacturer submits a Letter of Intent to Appeal, HC will publish information regarding the appeal process. This publication occurs after the issuance of a decision on the appeal, following the guidance outlined in “Management of Applications for Medical Device Licences and Investigational Testing Authorizations.”
For first-level appeals, if the manufacturer fails to provide the necessary information supporting the appeal, HC will initiate publication 21 days after receiving the Letter of Intent to Appeal directed to the Bureau Director. For second-level appeals, HC will proceed with publication upon notifying the manufacturer of the directorate’s decision on the appeal.
Manufacturers will be notified by email when HC begins the publication of clinical information related to a negative decision. This notification will include the same details and procedures as those for positive decisions
Looking Ahead
As this policy takes effect, stakeholders are encouraged to leverage the available data responsibly. Health Canada plans to monitor the impact of this initiative and welcomes feedback to enhance the portal’s functionality and usability.
In an era where transparency and access to information are paramount, Health Canada’s decision to make clinical data on medical devices publicly available is a progressive step forward. It underscores a commitment to safeguarding public health and fostering trust through openness and accountability.
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References
Learn more about FDA. For the link, click here
Public Release of Clinical Information: guidance document
Clinical information on drugs and health products
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