A manufacturer must have a Medical Devices Establishment Licence (MDEL) before selling any Class II, III, or IV device in Canada. A distributor or importer of medical devices cannot legally sell an unlicensed medical device and is required to obtain an Establishment Licence from Health Canada to ensure that proper distribution records are kept and procedures are in place for handling complaints, reporting mandatory problems and recalling devices. Medical devices sold by foreign manufacturers directly to health care facilities are also required to have a valid Canadian Medical Device Licence.
It is the responsibility of the applicant to determine that the device(s) indicated on the application have been classified as a medical device and to obtain the correct classification of the medical device. Fees for the review of the application are not refunded should it be later determined that the product(s) are not medical devices or are of a different risk class. Refer to the Medical Devices Program regulations.
There are Health Canada contacts responsible for a variety of products so communicate with the appropriate agent responsible for the kind of products you are selling. You can email Health Canada at email@example.com for more information.
The Medical Devices Bureau-Therapeutic Products Directorate is the national authority that monitors and evaluates the safety, effectiveness and quality of diagnostic and therapeutic medical devices in Canada and decide if a product or medical device is safe to be sold in Canada.
The review of an MDEL application is 120 calendar days, on average, from the day it is received by Health Canada. The length of the review of device applications varies depending on the class of the device. Class III & IV Licence applications have a target review time of 75 days and 90 days respectively and Class II Licence applications have a 15 calendar day target.
Medical devices offered or imported for sale or use in Canada must meet the labelling requirements listed in sections 21 - 23 of the Regulations. Labelling for devices intended to be sold to the general public, the label information must be set out on the outside of the package. The information must be visible to enable the intended user to make an informed choice with respect to the device, and to permit the post-market identification of a device during a product recall.
Holders of an active medical devices establishment licence can be found by searching on Health Canada’s website by typing in the licence # or company id or a combination of the company name, activity, country, Province / State.
Medical Devices Active Licence Listing (MDALL) contains product-specific information on all medical devices that are currently licensed for sale in Canada, or have been licensed in the past. This system has been designed to help health care workers, who are contemplating the purchase of a Class II, III or IV medical device, to verify that the manufacturer has an active medical device licence.
If you are in consultation with Health Canada and they are aware of the products, Health Canada may provide an option that allows you to bring products into Canada under certain conditions. Where companies who have not attempted to communicate or comply to Health Canada’s requirements under the Food and Drugs Act (FDA) or the Medical Devices Regulations (MDR), the Inspectorate can take appropriate enforcement action to address the noncompliance.
Ask for the company’s MDEL # and product information and go to Health Canada’s MDALL searchable online databases. As a Canadian dentist you have an ethical responsibility to use products that are legally permitted to be sold in Canada.