10 Ways to Help your Business with Health Canada Compliance

As the leading Health Canada Consultancy, Dell Tech supports businesses in a variety of industries through every step of the regulatory process.  

Dell Tech's team has the necessary expertise to assist with the following product types: cosmetics, Natural Health Products (NHP), Over-the-Counter (OTC), biocide drugs, veterinary drugs and veterinary health products, pesticides, medical devices and more. 

Here's a general overview of the process and how Dell Tech can help:

1. Determine Product Category: Health Canada regulates various types of products, including pharmaceuticals, medical devices, natural health products, and more. Dell Tech will review your product formula and/or claims to determine which category your product falls under in order to understand the specific requirements.

2. Gather Information: Our consultants will help you compile all relevant information about your product, including its formulation, intended use, ingredients, manufacturing process, labelling, and packaging details. This information will be necessary for your application.

3. Pre-Clinical and Clinical Data (if applicable): For some product categories, such as OTC drugs or medical devices, you might need to provide pre-clinical and clinical data to demonstrate the safety and effectiveness of your product.

4. Quality Control: Dell Tech will assist you with developing a quality control system to ensure consistent manufacturing and product quality. This is particularly crucial for products requiring Good Manufacturing Practices (GMP) like medical devices.

5. Submit Application: Using 40+ years of experience, our team will prepare and submit your application to Health Canada. The specific requirements and forms will depend on the product category. Our team has a strong track record for successful applications.

6. Review Process: Health Canada will review your application and supporting documentation. Dell Tech will be your company's liaison to manage any requests for additional information or clarification during the review process.

7. Fees: Depending on the type of product and the application process, there may be associated fees. We'll make sure you're aware of the most current Health Canada fee schedule so that you can make the best decision for your business. 

8. Waiting for Approval: The review process may take some time. You will need to wait for Health Canada's decision regarding the approval of your product.

9. Post-Market Activities: After approval, Dell Tech will manage ongoing compliance requirements such as adverse event reporting, product updates, and more.

10. Renewal and Maintenance: Depending on the product category, you may need to renew your product's registration periodically and ensure that it continues to meet all regulatory requirements. We'll ensure you're aware of these requirements and manage renewals as necessary. 

Overall, Health Canada's primary goal is to protect and promote the health and well-being of Canadian consumers by regulating, monitoring, and providing information on a wide range of health-related matters. It works in collaboration with other government agencies, healthcare professionals, industry stakeholders, and the public to achieve these objectives.

Please remember that the process might vary depending on the type of product you're registering, and Health Canada's requirements can change over time. Contact us for up-to-date regulatory requirements, fee schedules, data requirements and more.