Notice: Classification of Artificial Larynx Devices

May 4, 2018

Our reference number: 18-104354-809

Effective April 26, 2018, artificial larynx devices (also referred to as electrolarynx devices) will be classified as Class I medical devices. This decision to reclassify electrolarynx devices (from Class II to Class I) is in accordance with Rule 12, Schedule I, Part 1, of the Medical Devices Regulations.

The reclassification decision is based on Health Canada’s recent review of the definition and intended use of electrolarynx devices. Classifying electrolarynx devices as Class I devices also better aligns the Canadian requirements with those of other international jurisdictions.

Based on a review of the definition and intended use of electrolarynx devices, and considering opportunities for international convergence, Health Canada concluded that these devices should be re-classified from Class II to Class I devices.

The availability of electrolarynx devices in Canada has been limited in recent years. It is expected that this reclassification decision will improve access for Canadians since aligning the Canadian requirements with those of other international jurisdictions should encourage manufacturers to sell their electrolarynx devices in Canada. As fewer pre-market regulatory requirements are associated with Class I medical devices than Class II medical devices (e.g. quality management system certification), Health Canada expects that this initiative will benefit Canadian patients and the health care system by leading to additional choices on the Canadian market.

Please note that Class I manufacturers may be subject to establishment licensing requirements. Manufacturers of electrolarynx devices should refer to Health Canada’s guidance document, Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees (GUI-0016), for more information.

Questions or concerns regarding the reclassification of electrolarynx devices should be directed to:

Medical Devices Bureau - General Inquiries Contact Information
E-mail: MDB_Enquiries@hc-sc.gc.ca
Telephone: 613-957-4786
Facsimile: 613-957-6345
Teletypewriter: 1-800-465-7735 (Service Canada)

For inquiries about establishment licensing please contact:

Regulatory Operations and Regions Branch
Medical Devices Establishment Licences
E-mail: MDEL_questions_LEPIM@hc-sc.gc.ca
Telephone: 613-954-6790
Facsimile: 613-957-4147
Teletypewriter: 1-800-465-7735 (Service Canada)

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