Health Canada is the regulator of therapeutic products, including medical devices. Health Canada’s Medical Devices Active Licencing Listing (MDALL) contains a list of products that are already in the Canadian medical device market.
It also contains the database for products that were previously licensed. This article discusses the various information available on MDALL.
Read our article on overview of medical device registration in Canada to understand the various license requirements for different classes of medical devices.
In brief, there are two types of licenses- Medical device establishment license (MDEL) and medical device license (MDL). MDL, the latter of the two, is for medical devices that fall under the category of device class II, III and IV. Medical Device Establishment License (MDEL) is for Class I devices.
The Medical Devices Active Licensing Listing (MDALL) database has the license information of all medical device license or MDL.
The Bureau keeps track of all licenced Class II, III, and IV medical devices for sale in Canada. Class I medical devices do not require a medical device licence and are controlled through Establishment Licensing by the Health Products and Food Branch Inspectorate (Compliance and Enforcement).
There are two types of licenses searches available on MDALL:
- Search Active Licences and
- Search Archived Licences
Search Active license opens the Medical Devices Active Licence Search window. In the Search Active Licence window, only products that are currently licenced for sale in Canada will be displayed.
Health Canada Database Details
This window allows you to search the database using one of six parameters:
- Company Name,
- Licence Name,
- Device Name
- Company ID
- Licence Number and
- Device Identifier
Search Archived license opens the Medical Devices Archive Licence Search box. This section of the system contains data on all items ever licenced by the Medical Devices Bureau, with the query result color-coded.
Obsolete products are displayed in red, while currently, active products are in black. This window provides only three search parameters, which are as follows
- Licence number
- Device name and
- Device identifier
Health Canada cautions users to not import or purchase medical devices that are not permitted for sale in Canada.
FAQs
What is the use of a medical device license database?
A database of medical devices or license helps the end user understand the quality of a product. It also ensures that the device that is in use is easily traced to it manufacturer. Countries like US and Canada have a well-established device database for transparency. Countries that do not have this may have the devices documented but the information may not be accessible to public.
Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.
I am looking for the status of a diagnostic medical device submitted for approval by SQI Diagnostics Inc., located in Toronto, late last year. The product’s brand name is RALI-dx.
Thank you.
Edward J M Yablonski
October 12,2022