OUR SERVICES INCLUDES:
.png)
NATURAL HEALTH PRODUCT
In Canada, Natural Health Products (NHPs) are health products with active natural ingredients used to support or maintain health. They come in various forms like tablets, capsules, and gels, and include everyday items like toothpaste, shampoos, and facial products.
​
To manufacture, package, label, or import NHPs for commercial sale, you must comply with NHP Regulations. Health Canada issues an NPN (Natural Product Number) or DIN (Drug Identification Number) which is an eight-digit identifier that authorizes you to sell NHPs in Canada.
Product analysis
Design packaging and labelling in english & french
Step-by-step guidance to obtain your health canada certification
OUR SERVICES INCLUDES:
.png)
COMESTIC PRODUCT
Any professionally made beauty product for cleansing, improving the complexion, skin, hair, or teeth falls under cosmetic regulations. Common examples include fragrances, skincare, haircare, and manicure products.
Under these regulations, importers and manufacturers must submit a Cosmetic Notification Form to Health Canada within 10 days of selling a cosmetic product in Canada. This form reports the ingredients used, enabling authorities to assess the product's suitability for sale.
Non-compliance with these regulations can lead to significant financial penalties or other sanctions.
Review cosmetic Ingredients
Prepare and submit your cosmetic notification form to Health Canada
Make corrections if required and resubmit the Cosmetic Notification Form
OUR SERVICES INCLUDES:
.png)
MEDICAL DEVICE LICENSE
Medical devices encompass a wide range of instruments used to treat, diagnose, or prevent health conditions, including pacemakers, hip implants, thermometers, and syringes.
In Canada, these devices are classified into four classes. Class I devices, like bandages and basic surgical instruments, pose the lowest risk and don't require a license. Classes II, III, and IV, which include devices from hearing aids to implantable neurostimulators, require a medical device license and must meet stringent safety and effectiveness standards.
All medical devices must comply with Canadian medical device regulations.
Medical Device analysis
Prepare and submit MDL or MDEL applications on your behalf
Serve as your regulatory correspondent with Health Canada for device registration
Step-by-step guidance to obtain your health canada certification
Step-by-step guidance to obtain your health canada certification
OUR SERVICES INCLUDES:
.png)
MEDICAL DEVICE ESTABLISHMENT LICENSE(MDEL)
A Medical Device Establishment Licence (MDEL) is a Health Canada authorization for manufacturing, importing, advertising, or selling medical devices in Canada. MDELs ensure that only authorized individuals can handle medical devices, maintaining safety and quality standards.As an MDEL holder, you must ensure that all devices meet Health Canada’s safety and effectiveness requirements, maintain quality assurance records, and report any device-related incidents.To obtain an MDEL, companies must submit a complete registration package, including safety, performance, and design information, along with an application fee. Fees vary based on the device class and application complexity, and costs for regulatory compliance should also be considered. Once approved, Health Canada issues an MDEL number, confirming the device meets all criteria for sale in Canada.
Verify the class of your medical devices, determine if a license is needed,
and check eligibility for a fee exemption for the Medical Device License.
Prepare and submit your MDEL application, and respond to any inquiries
from Health Canada.
Develop and document SOPs for your MDEL activities to build a solid
foundation for a quality management system
Submit a small business fee reduction application if your business qualifies
Conduct routine audits and review updates to your standard operating procedures after you receive your license
OUR SERVICES INCLUDES:
.png)
QUALITY ASSURANCE
Companies manufacturing, labeling, packaging, or importing health products or dietary supplements for sale in Canada must train their staff in GMP (Good Manufacturing Practices) to meet regulatory requirements. We can help ensure your facility is supported by qualified staff and complies with Health Canada standards.
Site Audit
GMP Training
SOP Technical Writing
Quality Non-Conformance Investigation
GET IN TOUCH WITH OUR HEALTH CANADA COMPLIANCE EXPERTS
Schedule an intro call with us and let our team experts help you today
The head office:
639 Queen St W #501,
Toronto,
ON M5V 2B7
Canada