What Is a Canadian Medical Establishment License?

The Canadian Medical Device Establishment license affects both human and veterinary medical supply companies. Those seeking licensure must complete application materials available through the Health Canada website. The Establishment Licensing Unit oversees approval of these applications.

Definition

• The Medical Device Establishment license is used to regulate manufacturers, importers and distributors of medical devices throughout Canada. According to Health Canada regulations, medical devices refer to any item used to prevent, diagnose or treat medical conditions. In addition, devices used to diagnose pregnancy and care for offspring of humans and animals are also covered under the regulations.

Exceptions

• Some individuals and institutions are not required to obtain a Canadian Medical Establishment license. Health care facilities, retailers, dispensers and certain manufacturers that have obtained other medical device licenses are exempt from these regulations, according to Health Canada.

Purpose

• The purpose of the license is to provide the Canadian government with oversight of the manufacture and distribution of medical devices. Medical Establishment licensing standards ensure that individuals and companies maintain legal and safe conditions during the production and release of medical devices for humans and animals.