How to register your private label medical device in Canada
Learn how to register a private label medical device with Health Canada. Follow this step-by-step guide to ensure regulatory compliance.
... Read moreIn Canada, the food and beverage sector includes the online selling of packaged and fresh foods (but not infant food), delicacies, and drinks. It comprises the selling of vegetables, fruit, snacks, pasta, refrigerated products, soft drinks, frozen meals, alcoholic beverages, and other similar items. The most important channels for the online selling of food and beverages are online shops, major supermarkets, and warehouse stores.
In terms of production value, the food and beverage industry is Canada’s second-largest industry. It accounts for more than 16% of overall manufacturing sales and contributes 2% of our national GDP.
The Health Canada Food Safety Regulations are a set of guidelines and requirements that businesses in the food industry must follow to ensure the safety of their products. These regulations cover a wide range of topics, including food handling and storage, labeling requirements, and the use of additives and preservatives. By following these regulations, businesses can help prevent foodborne illnesses and ensure that their products are safe for consumption.
The Canadian Food Inspection Agency (CFIA) is responsible for enforcing the Health Canada Food Safety Regulations. They work to ensure that businesses in the food industry are following the guidelines and requirements set out by Health Canada. The CFIA conducts inspections, investigates complaints, and takes enforcement action when necessary to protect the health and safety of Canadians. By working closely with Health Canada, the CFIA helps prevent foodborne illnesses and ensures that Canadians have access to safe and healthy food.
In Canada, businesses in the food industry are required to meet a number of food safety requirements to ensure that the food they produce is safe for consumption. These requirements include things like proper food handling and storage, maintaining clean and sanitary facilities, and ensuring that all employees are trained in food safety practices. Businesses must also keep detailed records of their food safety practices and be prepared to provide them to inspectors upon request. Failure to meet these requirements can result in fines, the closure of the business, or even criminal charges in severe cases.
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CFIA (Canadian Food Inspection Agency) regulates standards pertaining to food packaging, labeling, and advertising in Canada. Failure to comply with the agency’s regulatory compliance requirements will result in severe fines. Your items might be prohibited from being sold in the traditional or internet markets. To guarantee that your goods fulfill Health Canada Regulations you must create foods with increased nutritional value, nutrient information in a consistent manner, and label compliance. Some regulatory restrictions apply only to specific food items, such as seafood, low-acid canned food, or juice, whilst others apply to all food enterprises. For more information on applying for your safe food for Canadians License you can contact us using the form below.
Food Directorate division supervised by Health Canada is accountable for the safety and nutritional information for conventional and supplemented foods.
Providing nutritional information such as calories, serving size, percent daily value (% DV) of foods, and including the listing of 13 nutrients is mandatory.
Health Canada and the Canadian Food Inspection Agency (CFIA) govern Canada’s food label regulations. Label requirements include country of origin, units of measure (where applicable), bilingual nutrition facts table, allergen statements.
Leverage our expertise in Food and Beverage Compliance in Canada and take your food from your company to consumers. Our range of compliance solutions includes auditing, training, product classification, ingredient assessment, and more.
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.
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 process, 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.
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.
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!
Risk statements, directions of use and other labelling items may be required on the label for supplemented foods, depending on the number and type 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).
Learn how to register a private label medical device with Health Canada. Follow this step-by-step guide to ensure regulatory compliance.
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