Dental Instruments Manufacturers in Canada

Often not, depending on how it sells. Health Canada's establishment licensing guidance (GUI-0016) exempts, among others, Class I manufacturers that sell only through a Medical Device Establishment License (MDEL) holder. A foreign Class I manufacturer that ships to Canadian customers itself, without an MDEL-holding importer or distributor, would generally need its own MDEL.

The Canadian importer or distributor needs an MDEL for devices of any class, whatever the volume. Leasing or renting counts as selling. Check the exemption list in GUI-0016 for your situation. Canadian companies are on the Canada country page.

Canada

Typically Class I. Rule 3 of Schedule 1 to the Medical Devices Regulations places surgical or dental instruments that are reusable and not intended to be connected to an active device in Class I, despite the general rules for invasive devices. Class I devices do not need a Medical Device License (MDL).

Disposable instruments, or instruments connected to an active device, may be Class II or higher and then need an MDL supported by an MDSAP certificate. Manufacturers are responsible for classifying their own devices, using Health Canada's guidance and keyword index. See the medical certifications page.

Medical certifications

They license different things:

• A Medical Device License (MDL) authorizes the sale of specific Class II, III or IV devices and is issued to the manufacturer named on the label. New applications must include an MDSAP certificate.
• A Medical Device Establishment License (MDEL) authorizes an activity. Importers and distributors of all device classes, and manufacturers of Class I devices, need one unless an exemption applies (for example, retailers and health care facilities).

Reusable surgical instruments are typically Class I in Canada (Rule 3), so they need no MDL, but the importer or distributor needs an MDEL. An MDEL does not certify the safety of any device. See the medical certifications page.

Medical certifications

Ask for its Medical Device Establishment License (MDEL) number and check it against Health Canada's public listing. MDEL holders must:

• have documented procedures for distribution records, complaint handling, mandatory problem reporting and recalls, where applicable;
• notify Health Canada of changes to license information within 15 calendar days;
• submit an annual license review before 1 April each year.

For Class II to IV products, also check that the manufacturer holds a valid Medical Device License for the exact device. An MDEL does not certify any device. The directory currently lists 10 companies in Canada, with city pages for Toronto and Morrisburg; see the Canada country page.

Canada