MDEL explained: who needs one and what Health Canada looks at

Two licences, two jobs

Health Canada issues two kinds of licence for medical devices, and they are often confused.

• A medical device licence (MDL) authorizes a manufacturer to import or sell a specific Class II, III or IV device in Canada. It belongs to the manufacturer and covers the device.
• A medical device establishment licence (MDEL) authorizes a company to import or distribute medical devices. It covers the establishment and its activities, not any particular device.

An MDEL holder is responsible for confirming that the devices it imports or sells are licensed at the time of import or sale. Holding an MDEL does not make an unlicensed Class II to IV device saleable.

Who needs an MDEL

In general, anyone who imports or sells a medical device for human use in Canada needs one. In practice, that means:

• Importers, who bring devices into Canada from a manufacturer or supplier outside the country.
• Distributors, who buy devices from a Canadian manufacturer, importer or distributor and sell them on.
• Class I manufacturers who import or distribute their own devices.

The licence applies to all device classes. A distributor that only handles Class I products still needs an MDEL. Leasing and renting count as selling.

Who is exempt

Section 44 of the Medical Devices Regulations lists the exemptions. The main ones are:

• Retailers selling to the end user for personal use, including Class I manufacturers who sell only to end users.
• Health care facilities that provide diagnostic or therapeutic services to patients.
• Manufacturers of Class II, III or IV devices selling devices for which they hold a valid MDL, provided they do not import or sell other companies’ devices.
• Class I manufacturers that import or distribute solely through an MDEL holder, again provided they do not sell other companies’ devices.
• Dispensers, and some other narrow cases such as devices for animal use only and devices imported solely for export.

The exemptions are narrow. A Class II manufacturer that starts distributing a partner’s product, for example, loses the exemption for that activity. Check the current text of the Regulations and Health Canada’s guidance for your exact situation.

What Health Canada looks at

MDEL holders must show that they meet the regulatory requirements and have documented procedures in place, where they apply, for the devices they import or distribute. Health Canada’s guidance links these to the parts of the Regulations covering distribution records, complaint handling, recalls and mandatory problem reporting. Where an establishment stores, handles or delivers devices, those activities need procedures too.

Health Canada inspects MDEL holders to check compliance. Any party carrying out a regulated activity can be inspected at any time. It can also add terms and conditions to an MDEL when it identifies a risk with a specific activity, rather than suspending the whole licence.

Keeping the licence

To keep an MDEL active, the holder must:

• Submit an annual licence review application before April 1 of each year.
• Notify Health Canada within 15 calendar days of changes to the information named in paragraphs 45(a) and (b) of the Regulations.
• Keep procedures current and be ready for inspection.

Fees apply to the application and are not refunded once the review has started. Check Health Canada’s current fee page before applying.

Where we help

We provide consulting support to companies applying for and maintaining their own MDEL: working out whether you need one, preparing the procedures behind the attestation, and reviewing them before an inspection. We do not hold an MDEL or act as an importer or distributor for clients.

If you are deciding whether to import a device category at all, the importer and distributor landscape shows which licensed establishments already operate in it.