Medical Devices
We have prepared the following high-level info sheet to provide you with more information about the process for obtaining a Medical Device Licence in Canada.
The Regulator
Health Canada is a ministry of the government of Canada with responsibility for national public health. Health Canada reviews all medical device applications, enforces quality system requirements and monitors the safety records of medical devices imported and sold in Canada.
Applications
Canada organizes medical devices into classes 1, 2, 3 and 4. When applying for a Medical Device Licence, the first step is to review schedule 1 of the Canadian Medical Devices Regulations to confirm the class for your medical device. This also includes, US or European manufacturers as Health Canada does not recognize US or European approvals. The Medical Device Licence application is a technical dossier that contains all relevant information about your medical device including a risk analysis. Once you have completed your medical device application and received your ISO 13485 certificate from the ISO registrar, your technical dossier is submitted to Health Canada for review. Please see below if your company is already ISO 13485 certified.
If you ship a class 1 device directly to a customer in Canada, you will need a Medical Device Establishment License.
If you sell solely through a Canadian distributor your distributor must already have a Medical Device Establishment Licence to sell medical devices in Canada.
Quality System Requirements
Before manufacturers of class 2, 3 and 4 products can obtain their medical device licence, they must comply with Canada’s quality system requirements. All class 2, 3 and 4 manufactures are required to implement a quality management system that meets ISO 13485.
If your device already has European “CE” marking (“Conformité Européene” which literally means “European Conformity”), you may have ISO 13485 Certification. Nonetheless, additional requirements must be met in order to obtain a Medical Device Licence in Canada. An important note: compliance with US FDA quality system regulation does not address Canada’s regulatory system requirements. Once ISO 13485 is implemented as per the applicable Canadian regulations, you will need to be audited by an ISO Canadian Registrar authorized by Health Canada.
If your company is already ISO 13485 certified, it may be possible to add Canada to the scope of your certification in your country of origin. However, you will need to undergo a one-day audit to update your ISO 13485 certification. If your device requires testing and has been tested to an international standard in another market, those testing reports will be accepted as part of your application to Health Canada. Clinical data from other markets are generally accepted as well.
Approval
If approved, Health Canada will issue your Medical Device Licence and post the licence information on their website. Licences do not expire as long as you renew your licence annually and pay the renewal fee.
Timelines
Timelines vary. We have a detailed chart that provides information for all classes of devices sold in Canada. We can provide this information to you upon request.
Fees
Government fees vary. We have a detailed chart that provides information for all fees. We can provide this information to you upon request.
Cosmetic Products
We have prepared the following high-level info sheet to provide you with more information about importing and selling cosmetic products into Canada. All cosmetics sold in Canada must be safe to use and must not pose any health risk. They must meet all legal requirements set out in the regulations.
In particular, 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.” This includes cosmetics used by professional aesthetic services, bulk institutional products (such as hand soap in school rest rooms), as well as “handmade” cosmetics sold at craft sales or home-based businesses.
The regulations require that cosmetics sold in Canada be manufactured, prepared, preserved, packed and stored under sanitary conditions. Helpful tips include:
The Regulator
Health Canada. Health Canada is tasked with ensuring that all cosmetics sold in Canada are safe for use.
List of Ingredients
Before deciding to enter the market, it is important to review the list of ingredients that are restricted and prohibited in Canada. This will help you to determine whether you will be able to sell the product in Canada. If a cosmetic does contain an ingredient that is not on the list, a company must submit a new substance notification form.
Labelling Requirements
Any product sold in Canada must adhere to the regulatory requirements for labelling. This includes the labelling styles accepted, warning requirements and mandatory English and French on the label.
Product Examination
There are also specific rules regarding the examination of your product by an inspector. All documentation must be readily available to ascertain that the product is safe for use.
Cosmetic Notification Forms (CNF)
The CNF must be provided to Health Canada, within 10 days after a cosmetic is sold in Canada. The CNF includes the following information :
The completed Cosmetic Notification Form (CNF) provides specific product information to Health Canada, including:
- Address and contact information of the manufacturer(s), importer(s), distributor(s), and formulator(s)
- Function of the cosmetic
- Form of the cosmetic (for example, cream and gel)
- Ingredients of the cosmetic
- Concentration of each ingredient
Fees
There is no government fee associated with the cosmetic notification process.
