Health Canada Expands Public Access to Clinical Data for Medical Devices

Tamara Schoyen 

Background 

As Emergo by UL reported, Health Canada has a clinical information database.

In 2019, the regulator in Canada, Health Canada (HC), began a phased approach to publishing clinical information submitted by drug and medical device manufacturers in support of Class III and IV Medical Device Licenses (MDL). In 2021, HC began proactively publishing clinical information for new submissions. For devices, clinical information includes testing and investigations performed to evaluate safety and performance.

The Public Release of Clinical Information initiative

Clinical information provided in support of an application will be made public and can be accessed via HC’s portal. This may include, but is not limited to, the following: clinical summary, clinical data study protocols and reports, literature studies and Clinical Evaluation Reports. 

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. As of Nov. 14, 2025, 166 records have been posted.

Manufacturers can 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), to be conducted virtually. The purpose of the PIM is to allow manufacturers to consult with HC on the clinical documents to be released under the PRCI and provide an opportunity to clarify HC’s requirements and process. 

HC allows manufacturers the opportunity to de-sensitize and redact information prior to uploading clinical information, if it is considered personal information (PI) or meets the definition of confidential business information (CBI) as defined in the Guidance document on Public Release of Clinical Information.

The Medical Devices Regulations were amended in 2019 to specify that clinical information ceases to be considered CBI following a final regulatory decision. This amendment authorizes the Minister (HC) to publicly release such information without notification or consent (see section 43.12).

According to the PRCI guidance document, two categories of information may still qualify as CBI under the Food and Drugs Act:

• Information submitted by the manufacturer that did not support the features of the device related to its intended medical conditions, purposes or uses.
• Information concerning tests, methods or assays that are used exclusively by the manufacturer.

To support procedural fairness, the PRCI team provides the Marketing Authorization Holder (MAH) with two opportunities to submit justifications regarding any residual CBI within the documents identified for release. 

As stated in section 4.4 of the guidance document:

“Health Canada may return to the manufacturer on one additional occasion to seek additional justification. The final decision on what clinical information is publicly released rests with Health Canada.”

Additionally, section 4.5 reinforces that: “Health Canada retains final decision on what information is publicly released.”

Once the second assessment is complete, it is considered final, and the documents are published in accordance with the assessment. 

There is no formal process to appeal the release of these documents.
 

Negative regulatory decisions to be published as well

It is important to recognize that in the event that an MDL application is unsuccessful and an MDL is not granted, the information will still be published. However, to date, only clinical data on approved MDLs is included in the database. 

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 PRCI: Public Release of Clinical Information: guidance document - Canada.ca
• Learn more about the PRCI portal: Clinical information on drugs and health products - Canada.ca

HC provides clinical information for Class III and Class IV medical devices in the PRCI. This may serve as an additional source for clinical data on different high-risk devices. In addition, as part of their business and regulatory strategy, manufacturers should assess the ramifications of publicizing their clinical approach.