FAQs

Natural Health Products
What is needed to sell a Natural Health Product in Canada?

Several key pieces are required to sell an NHP in Canada: A Natural Health Product Number or NPN, a compliant and bilingual label, your foreign or domestic manufacturing/packaging/labelling site to be annexed to a Canadian NHP Site License. Quality Smart and Import Solutions offers a turn-key solution for all these activities. Reach out to our team to inquire about of the range of services we can offer.

Does my Natural Health Product need to be tested?

Yes, Health Canada expects all finished products to be tested. Some items to test are: microbiological contaminants, solvent residues, pesticides, and medicinal ingredient amounts (if applicable). Different types of NHPs may require different testing protocols. For further information on testing please reach out to our team or consult the Quality of NHPs Guide.

Is there a fee associated with licensing for Natural Health Products?

Currently, there is no cost recovery issued by Health Canada for the licensing of Natural Health Products. Health Canada has considered this in the past, but nothing has been finalized.

How long will it take to receive my Natural Product Number (NPN)?

Once the application is submitted, the standard review timelines for Health Canada are as follows: Class I – 60 days, Class II – 90 days, Class III – 210 days. Health Canada’s backlog of applications and the pandemic has impacted these timelines, and their reviews are taking considerably longer for all classes.

My Natural Health Product is manufactured outside of Canada. What do I need to do to import the product to Canada?

You will need an NPN and a compliant/bilingual label.

You will also need to annex your foreign site to a Domestic NHP Site License. Depending on what kind of Quality documentation your site already carries, you may qualify for a pre-cleared annexation stream. Otherwise, you will have to complete a full QAR form and submit additional records and SOPs to support the GMP activities conducted at your site.

Please reach out to our team if you have any further questions or if you would like any of your documentation, formulas or labels reviewed by our staff! We’re happy to help!

Medical Devices Canada
What is a Medical Device?

The term Medical Device, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition.

Who regulates Medical Devices in Canada?

Health Canada is the federal regulator of therapeutic products, including medical devices. Specifically, the Medical Devices Bureau (Bureau) of the Therapeutic Products Directorate at Health Canada is the Canadian federal regulator responsible for licensing medical devices in accordance with the Food and Drugs Act and Regulations and the Medical Devices Regulations.

How are Medical Devices classified?

As per section 6 of the Medical Device Regulations, medical devices are classified into one of four classes where Class I represents the lowest risk devices and Class IV the highest risk devices.

What is a MDEL?

A Medical Device Establishment Licence (MDEL) is a licence issued to manufacturers of Class I medical devices as well as importers or distributors of all device classes. The MDEL permits them to import or distribute a medical device in Canada. An MDEL provides Health Canada assurance that medical devices sold or imported into Canada meet the safety requirements set out in the Medical Devices Regulations, and that procedures are in place to protect the public should a problem with a device be identified. The MDEL listing contains information about the licensed establishment including their company ID, licence number, company name, address, authorized activities and associated class of device(s).

Medical Devices USA
What is a Medical Device?

A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is— 

  • recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them
  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or 
  • intended to affect the structure or any function of the body of man or other animals, and 

which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes

How does the FDA classify Medical Devices?

The FDA places all medical devices into one of three regulatory classes based on the level of control necessary to ensure safety and effectiveness of the device.  Classification is risk based, that is, the risk the device poses to the patient and/or the user is a major factor in determining the class to which it is assigned. Class I devices are considered low risk and Class III devices are considered high risk.

What is a premarket notification (510(k)) submission?

A premarket notification, or 510(k), is submitted to FDA before a manufacturer proposes to market a medical device.  If FDA agrees the new device is substantially equivalent to a legally marketed device for which premarket approval is not required, the manufacturer may market it immediately. FDA does not require clinical data in most 510(k)s.

What is a premarket approval (PMA) application?

A premarket approval (PMA) application is the most stringent type of device marketing application for medical devices.  FDA approves a PMA if it determines that the application contains sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use(s).

Dietary Supplements
What is needed to sell a Dietary Supplement in the USA?

Notifications are required for any new ingredient being formulated into a Supplement or to register any health claims to be made for your product. It is important that all claims being made, and all ingredients are verified for compliance.

How long will it take to receive approval for my Dietary Supplement?

For a new ingredient, roughly 75 days prior to the introduction market the notification should be sent to the FDA. For a notified Health claim, it may be used approximately 120 days after the submission is filed with the FDA. During that time, the FDA may issue additional questions or requirements regarding your ingredient or claim. Our specialists are ready to help with your notifications or any related questions. Please contact our team!

Are there any specific labelling requirements for Dietary Supplements?

FDA regulations require that certain information appears on dietary supplement labels. Information that must be on a dietary supplement label includes:

  • a descriptive name of the product stating that it is a “supplement;”
  • the name and place of business of the manufacturer, packer, or distributor.
  • a complete list of ingredients.
  • the net contents of the product.
  • must have nutrition labelling in the form of a “Supplement Facts” panel. This label must identify each dietary ingredient contained in the product.

For assistance with Dietary Supplement labelling, please reach out to our friendly staff.

Food and Beverage
How does dosage format affect product classification?

Food products are thought to be served by ad libitum consumption. The nutrition facts panel is targeted at explaining the daily serving amounts to the consumer. Consumers are responsible for making decisions on their own for this category.

NHPs are thought to have regimented dosing much like drugs. The directions of use, risk information, and recommended uses inform the consumer. Consumers make their own decision here as these are not prescribed but often discuss these types of products with their doctors. 

Some traditional food type formats are beverages and snack bars whereas NHP type formats are tablets and capsules. Health Canada has published a helpful guidance document for products that sit on the NHP Food Interface.

What is needed to sell Food and Supplemented Food in Canada?

A supplemented food requires temporary market authorization (TMAL) to be sold in Canada. Currently, this process takes 12+ months after submission for Health Canada to review your formula, the label, and your marketing strategy. During this review, Health Canada will thoroughly review your submission and may request formulation, marketing or label content changes. There are also additional post-market requirements associated with holding this type of license that is agreed upon with Health Canada during their review. This may include adverse event reporting, etc.

Is there a fee associated with licensing a Supplemented Food?

Currently, there is no cost recovery collected by Health Canada for the licensing of Temporary Market Authorizations. Health Canada may have considered this in the past, but nothing has ever been finalized.

How long will it take to receive my Temporary Market Authorization?

There are no published standard timelines for TMAL applications. However, we are currently seeing applications take 12+ months. Please reach out to our team to get started on a formula or label review for any of your food or supplemented food products. We’re happy to help!

Are there any specific labelling requirements for Foods and Supplemented Foods?

Risk statements, directions of use and other labelling items may be required on the label for supplemented foods, depending on the number of ingredients within the formula. This is explained in the application guidance document to which your product best fits and can be assigned by Health Canada during their review of your application. Similarly, both products (regular food and supplemented food) will require a Nutrition Facts Panel and will follow general food labelling regulations. As per Canadian regulations, your label will also need to be bilingual (English and French).

Cosmetic Products
What is a cosmetic?

Under the Food and Drugs Act, a cosmetic includes “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.”

How do I register my Cosmetic product in Canada and how much does it cost?

Manufacturers and importers must notify Health Canada within 10 days after they first sell a cosmetic in Canada. Therefore, a Cosmetic Notification must be submitted to notify Health Canada of your cosmetic product. There is currently no fee associated with the cosmetic notification process.

What are some examples of cosmetic products and non-cosmetic products?

Cosmetic products can include: soaps, manicure products, adhesives for use on the body, moisturizers, tattoo inks, makeup products, tooth whiteners and cleansing wipes. Non-cosmetic products would be things such as: sunscreens, acne treatments, skin whiteners/lighteners, hand sanitizers, collagen/botox injections, insect repellants, oral supplements and contact lenses.

What types of claims can my cosmetic products make?

Cosmetic claims must be non-therapeutic in nature (e.g. moisturizing, cleansing, beautifying, etc.) and they do not require prior authorization by the regulator. Therapeutic claims (e.g. modify body functions, prevent or treat disease) are only allowed on drugs or natural health products, not on cosmetic products.

Are there any ingredients that are prohibited for use in cosmetics?

The Cosmetic Ingredient Hotlist (Hotlist) is an administrative tool that Health Canada uses to communicate to manufacturers and others that certain substances may be prohibited or restricted for use in cosmetics.

OTC Drugs
What is an OTC drug?

OTC stands for “Over-The-Counter”. Non-prescription drugs, also called over-the-counter drugs, are health products that can be bought without a doctor’s prescription. Canada regulates these types of products to ensure they are safe for use and reduce health risks to the public.

How do you sell an OTC drug in Canada?

Non-prescription OTC drugs require a valid Drug Identification Number (DIN) to be sold in Canada. 

What is a DIN?

A Drug Identification Number (DIN) is a computer-generated eight digit number assigned by Health Canada to a drug product prior to being marketed in Canada. It uniquely identifies all drug products sold in a dosage form in Canada and is located on the label of prescription and over-the-counter drug products that have been evaluated and authorized for sale in Canada. A DIN lets the user know that the product has undergone and passed a review of its formulation, labeling and instructions for use. A drug product sold in Canada without a DIN is not in compliance with Canadian law.

What is the Drugs Facts Table and how does it apply to Non-prescription drugs?

Through Health Canada’s Plain Language Labelling Initiative, there are new requirements for health product labelling and packaging, including a requirement for a Drug Facts Table (Facts Table) on the outer label of non-prescription drugs. The standardized format of the Drug Facts Table will help consumers find important product information quickly and easily.

Veterinary Health Products
What are Veterinary Health Products?

Veterinary Health Products (VHPs) are low risk drugs in dosage form that are used to maintain or promote the health and welfare of companion and food-producing animals. They are not for use to treat, prevent or cure disease. VHPs can contain ingredients such as vitamins and minerals, botanicals, traditional medicines and homeopathics with a history of safe use.

What is the VHP Notification Process?

Health Canada’s Notification Program for Veterinary Health Products (VHPs) provides a process to help companies meet the rules for importing and selling VHPs in Canada. VHPs must be notified to Health Canada:

  • At least 30 days before selling a VHP for the first time in Canada
  • At least 30 days before making a change to a VHP that is already notified in Canada
  • Before importing a VHP into Canada
Is there a fee associated with submitting a VHP Notification?

Yes. As of April 1st, 2020, there is a fee of $486 (CAD) for each VHP Notification. Fees can be reduced for VHP Notifications submitted by a small business.

What is the List of Permitted Substances?

 VHPs can only contain Health Canada-approved substances on the List of Permitted Substances, including active, homeopathic, traditional medicine and non-medicinal ingredients or substances. If any of the ingredients in your VHP are not on the List of Permitted Substances, you may submit a New Substance Application form. Health Canada will review the application form and determine if there is sufficient information to add or make a change to an ingredient on the List of Permitted Substances and whether conditions should be applied.

Are there labelling requirements for VHPs?

Yes. Labelling rules for drugs (including VHPs) are outlined in the Food and Drugs Act and Regulations. The label text must be identical to the information provided in the authorized VHP Notification Form. Furthermore, VHP labels must:

  • Include the statement “Veterinary health product / Produit de santé animale”
  • follow the labelling rules of the Food and Drug Regulations
  • include mandatory label statements as described on List C (ingredient specific label statements)

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