Hypertension Canada Device Validation Program: Get Your BP Device Validated and Listed
Hypertension Canada maintains a searchable list of blood pressure (BP) monitors that have been validated by our Device Recommendation Program Committee, and which meet rigorous validation standards.
In addition, manufacturers can opt-into our cause-related marketing program, which enables participating companies to use the Hypertension Canada Device Validation Program logo on their packaging to help consumers, healthcare providers, and pharmacies easily identify validated models. Using a validated BP monitor ensures reliable readings, which is critical for successful hypertension management.
Here’s how manufacturers can get their device validated and included in our online list of recommended devices:
Step 1: Submit Your Application
- Complete Hypertension Canada’s standard application form and checklist with your company name, device name, and model number.
- Include specifications such as measurement site (e.g., upper arm or wrist), cuff size range, and intended use (home, ambulatory, clinic).
- Ensure your application includes a Clinical Validation Study
- Include a validation study performed according to recognized international protocols (ISO / AAMI / ESH).
- Both published and non-published validation studies are accepted, so long as they are independent.
- If your study tested a different but similar device, include a detailed statement of equivalency between that device and the one you are asking HC to validate.
- A statement of equivalency is required for validation studies performed on a different model than the one being submitted for endorsement.
Step 2: Pay the Application Fee
The review fee must be paid before the review process begins.
Fee schedule:
- CAD $2,500 – 1 Primary Model
- CAD $500 – each Equivalent Model
- CAD $5,000 – Up to 3 Primary Models; each Equivalent Model = $500
- Application fees for 3 Primary devices are capped at $5,000. Costs for additional devices beyond this amount will be determined.
- Once you have submitted your application(s), the Hypertension Canada office will send an invoice for the review fee(s).
Step 3: Sign Required Agreements
- All companies must sign the Recommended BPM Device Agreement in order for their product to be considered for listing on the Hypertension Canada website.
- Companies that wish to participate in the optional marketing program—which allows them to display Hypertension Canada Device Recommendation Program trademarks (including the logo and checkmark) on their products, packaging, and promotional materials—must also sign:
- Schedule D – outlines the requirements of the Cause-Related Marketing (CRM) Program, including the requirement to pay Hypertension Canada 1% of device sales on a bi-annual basis
- Schedule E – the Trademark License Agreement granting permission to use the trademarks
- Participation in this marketing/trademark program is optional. Companies that choose not to enroll may still be listed as validated devices on the Hypertension Canada website, but they cannot use Hypertension Canada trademarks or claim “Recommended by Hypertension Canada” on any packaging, promotions, or materials.
Step 4: Committee Review
Hypertension Canada’s expert panel reviews your validation data and device specifications. If all criteria are met, your device will be approved and added to the recommended device list.
After Approval
- Once listed, your device appears on Hypertension Canada’s online recommended device list.
- Companies participating in the optional marketing program may also use the Hypertension Canada Device Validation Program logo on packaging and marketing materials.
- Notify Hypertension Canada of any changes such as new or retired models, design updates, or recalls.
- Hypertension Canada may periodically re-review devices to ensure ongoing accuracy and compliance.
What Consumers and Healthcare Providers See
- Devices on the list are displayed in a filterable catalog by brand, model, cuff size, and device type: List of Recommended Devices
- Devices participating in the Cause-Related Marketing (CRM) program display a Hypertension Canada logo on packaging or documentation to help consumers identify approved models.
- Hypertension Canada supports consumer education by actively encouraging the purchase of validated devices — which help people monitor BP more accurately, supporting better hypertension management over time.