Health Canada: Clinical Information on Medical Devices Now Publicly Available

By Tamara Schoyen

The medical device regulator in Canada, Health Canada (HC), has now made the clinical information provided in support of an application public and it can be accessed via HC’s portal. This may include the following information but not limited to the clinical summary, clinical data study protocols and reports, literature studies and Clinical Evaluation Reports.

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.

Manufacturers can meet with HC and redact sensitive information

HC will engage with manufacturers prior to the initiation of the PRCI, in which a sponsor may elect to attend a one-on-one process initiation meeting (PIM). The meeting will be conducted virtually. The purpose of the PIM is to allow a sponsor to consult with HC on the clinical documents to be released under PRCI and provide an opportunity to clarify HC's requirements and process.

HC will also allow manufacturers to de-sensitize and redact information prior to uploading the clinical information.

Negative regulatory decisions to be published as well

In the event an MDL application is found to not comply with the Medical Devices Regulation (MDR) and the manufacturer submits a Letter of Intent to Appeal, HC will initiate publication upon issuance of a decision of the appeal process, in accordance with the guidance "Management of Applications for Medical Device Licences and Investigational Testing Authorizations".

In the case of a first-level appeal, should the manufacturer not submit the necessary information supporting the appeal, HC will initiate publication 21 days after receipt of a manufacturer's Letter of Intent to Appeal to the Bureau Director. In the case of a second-level appeal, HC will initiate publication upon notification to the manufacturer of the directorate's decision on the appeal.

Manufacturers will be notified by email when HC initiates publication of clinical information related to a negative decision. The notification will include the same information and procedures as in the case of positive decisions (see above).

Concluding remarks

Additional information is available from the following HC resources:

• Clinical information portal: Search for clinical information on drugs and medical devices - Canada.ca;
• Guidance document on Public Release of Clinical Information: Public Release of Clinical Information: guidance document - Canada.ca; and,
• Learn more about the public release of the clinical information portal: Clinical information on drugs and health products - Canada.ca.

HC provides clinical information for Class III and Class IV medical devices in the PCRI. This may serve as an additional source for clinical data on different high-risk devices.  

Tamara Schoyen is a Senior Consultant, Quality and Regulatory Affairs at Emergo by UL.