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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.
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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.
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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.
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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.
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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.
OUR SERVICES INCLUDES:
NATURAL HEALTH PRODUCT
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Product analysis
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Design packaging and labelling in english & french
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Step-by-step guidance to obtain your health canada certification
COMESTIC PRODUCT
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Review cosmetic Ingredients
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Prepare and submit your cosmetic notification form to Health Canada
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Make corrections if required and resubmit the Cosmetic Notification Form
QUALITY ASSURANCE
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Site Audit
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GMP Training
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SOP Technical Writing
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Quality Non-Conformance Investigation
MEDICAL DEVICE ESTABLISHMENT LICENSE(MDEL)
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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.
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Prepare and submit your MDEL application, and respond to any inquiries from Health Canada.
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Develop and document SOPs for your MDEL activities to build a solid foundation for a quality management system
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Submit a small business fee reduction application if your business qualifies
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Conduct routine audits and review updates to your standard operating procedures after you receive your license
MEDICAL DEVICE LICENSE
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Medical Device analysis
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Prepare and submit MDL or MDEL applications on your behalf
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Serve as your regulatory correspondent with Health Canada for device registration
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Step-by-step guidance to obtain your health canada certification
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Step-by-step guidance to obtain your health canada certification