Canada’s Health Canada
Medical Devices
Canada’s Health Authority:
In Canada, manufacturers must receive a medical device licence for certain health products defined as a “device” under the Food and Drugs Act before they can be sold on the Canadian market. To determine which devices need a licence, all medical devices have been categorized based on the risks associated with their use. Prior to selling a device in Canada, manufacturers of Class II, III and IV devices must obtain a medical device licence.
Health Canada ‘Device’ definition:
A Device means an instrument, apparatus, contrivance or other similar article, or an in vitro reagent, including a component, part or accessory of any of them, that is manufactured, sold or represented for use in;
- diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms, in human beings or animals,
- restoring, modifying or correcting the body structure of human beings or animals or the functioning of any part of the bodies of human beings or animals,
- diagnosing pregnancy in human beings or animals,
- caring for human beings or animals during pregnancy or at or after the birth of the offspring, including caring for the offspring, or
- preventing conception in human beings or animals
GRP Medical Device Services:
Global Regulatory Partners Inc. (GRP) has a global presence with a team of local experts in Canada who can develop the appropriate regularly intelligence, strategy and pathway for the registration of your device. GRP’s services continue to post-market vigilance of your product after registration in the Canadian market.
More Resources:
- Read More– To access more information on Medical Devices and our services in Canada .
Regulatory Support for Medical Devices in Canada
Canada has a well-developed regulatory system for drugs and medical devices, allowing foreign manufacturers to register and market their products without requiring a local representative—except for devices incorporating wireless technology.
GRP Regulatory Affairs Services
GRP’s regulatory affairs team provides end-to-end support, including:
- Meeting Preparation & Submission – Writing, preparing, and submitting meeting packages to Health Canada.
- Regulatory Consultation Support – Preparing key questions based on your product’s development and strategic goals.
- Health Canada Meeting Assistance – Providing expert guidance and support during regulatory meetings.
- Post-Meeting Action Plan – Writing meeting minutes and developing a structured action plan for next steps.
GRP Medical Device Registration Services
Our expert team ensures smooth registration and compliance for your medical devices in Canada, offering:
✔ Device Classification Confirmation – Identifying the correct regulatory pathway for your device.
✔ MDL & MDEL Applications – Completing and submitting license applications on your behalf..
Pharmaceuticals
Canada’s Health Authority:
In Canada, sponsors who want to register their drugs in Canada must apply for ” New Drug submission” and successfully complete the review process by scientists in the Health Products and Food Branch (HPFB). Once the sponsor has completed the review the drug is issued a Notice of Compliance (NOC), and a Drug Identification Number (DIN) which permits the sponsor to market the drug in Canada.
Drug Definition in Canada:
According to the Food and Drugs Act, “a drug includes any substance or mixture of substances manufactured, sold or represented for use in:
- the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or its symptoms, in human beings or animals;
- restoring, correcting or modifying organic functions in human beings or animals; or
- disinfection in premises in which food is manufactured, prepared or kept.”
Natural health products, such as vitamin and mineral supplements and herbal products for which therapeutic claims are made are also considered drugs at the level of the Food and Drugs Act; however, these products are regulated as natural health products under the Natural Health Products Regulations and not as drugs under the Food and Drug Regulations.
Market authorization in Canada:
Before drug products are authorized for sale in Canada, Health Canada reviews them to assess their safety, efficacy and quality. Drug products include prescription and non-prescription pharmaceuticals, disinfectants and sanitizers with disinfectant claims.
More Resources:
- Read More– To access more information on Pharmaceuticals and our services in Canada .
Market Access of Pharmaceuticals
Regulatory Support for Pharmaceuticals in Canada
Canada is one of the few countries with a well-established regulatory framework for drugs and medical devices that does not require a local representative for market entry. Foreign manufacturers can register and sell their pharmaceutical products in Canada without a local entity, except for devices incorporating wireless technology.
GRP Pharmaceutical Services (Canada)
We provide comprehensive regulatory support to help pharmaceutical and medical device companies navigate Health Canada’s requirements. Our services include:
- Direct Communication with Health Canada – Acting as your liaison for regulatory inquiries and submissions.
- Product Registration – Assisting with new drug and medical device registrations to ensure compliance.
- Health Canada Inspection Support – Guiding companies through the inspection process to meet regulatory expectations.
- Regulatory Consultation Meetings – Organizing and supporting meetings with Health Canada for strategic discussions.
- Post-market variations – strategy & maintenance
With our expertise, we help streamline regulatory approvals and ensure compliance in the Canadian market.
Cosmetics
Cosmetic Definition:
In Canada a cosmetic is defined as ” any substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes.“
GRP Cosmetic Services:
To overcome the complexities of cosmetic regulation in Canada Global Regulatory Partners, Inc.(GRP), offers a comprehensive range of services for Cosmetics and Personal Care Products to ensure products meet the latest cosmetic safety regulations. With regional offices in North America GRP is well-positioned to support your regulatory needs in Canada. GRP’s team of professionals are experts in worldwide supply, registration, manufacturing and labeling of Cosmetics and PCPs. GRP helps manufacturers, distributors, and marketers of cosmetics in Canada.
More Resources:
- Read More- To access more information on Cosmetics and our services in Canada .
Regulatory Support for Cosmetics & Personal Care Products in Canada
In Canada, foreign manufacturers can register and market their cosmetics without requiring a local representative. GRP provides expert regulatory consulting services to help cosmetic and personal care product companies navigate Health Canada’s requirements.
Why Choose GRP?
We support manufacturers, distributors, and marketers in ensuring their products comply with Canadian regulations and reach the market efficiently.
Comprehensive Regulatory Strategy
GRP develops tailored regulatory strategies based on:
- Product Information & Market Landscape – Assessing your product and similar products available in the market.
- Product Development & Business Goals – Aligning regulatory requirements with your development milestones and objectives.
- Regulatory Compliance – Ensuring adherence to Health Canada’s regulations for cosmetics and PCPs.
- Packaging & Label Review – Verifying compliance with Canadian requirements.
- Regulatory Compliance Checks – Ensuring that product information is accurate and meets safety standards.
- Market Readiness Support – Helping your products meet all necessary requirements for sale in Canada.
- Timelines & Market Entry Planning – Providing a structured approach for efficient product approval and launch.
With GRP’s expertise, you can confidently bring your cosmetic and personal care products to the Canadian market while ensuring full regulatory compliance.
Nutraceuticals
‘Natural Health Product’ Regulations of Canada:
In Canada, nutraceuticals are known as Natural health products and are regulated under the Natural Health Products Regulations. However if the Natural health products (NHP) makes a therapeutic claim (s) they are considered drugs , and then will be regulated under the Food and Drug Act.
‘Natural Health Product’ Definition:
An NHP is defined as “A substance set out in Schedule 1 [NHPR] or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or a traditional medicine, that is manufactured, sold or represented for use in:
- The diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;
- restoring or correcting organic functions in humans; or
- modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.
However, a natural health product does not include a substance set out in Schedule 2 [NHPR], any of substances that includes a substance set out in Schedule 2 or a homeopathic medicine or traditional medicine that is or includes a substance set out in Schedule 2 [1, NHPR].”
‘Natural Health Product’ Market Authorization:
All natural health products sold in Canada, must have a product license, and the manufacture, package, label and import these products must have site license. In order to get product and site license, specific labelling and packaging requirements must be met, good manufacturing practices must be followed, and proper safety and efficacy evidence must be provided.