International Regulatory Affair Services
Isah Health


Health Canada

The term Medical Devices, as defined in the Canadian Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition.

In Canada, manufacturers must receive a medical device licence for certain health products defined as a "device" under the Food and Drugs Act before they can be sold on the Canadian market. To determine which devices need a licence, all medical devices have been categorized based on the risks associated with their use. Prior to selling a device in Canada, manufacturers of Class II, III and IV devices must obtain a medical device licence. Although Class I devices do not require a licence, manufacturers, distributors and importers are required to obtain an establishment licence.

Our services are orientated to assist you on getting from the Canadian Health Agency the required licenses for Medical Devices.

Health Canada requires medical device manufacturers to use a quality system certificate as evidence of compliance to the appropriate regulatory quality system requirement. Health Canada will only accept quality system certificates that have been issued by special third party auditing organizations called Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrars. The Medical Devices Regulations do not require importers or distributors of medical devices to have a registered quality system.

The Medical Devices Regulations require class II, III and IV medical devices to be manufactured (class II) or designed and manufactured (class III & IV) under CAN/CSA ISO 13485:2003. There are no regulatory quality system requirements for Class I medical devices. These quality system requirements came into force on January 1, 2003.

Our services are orientated to provide the requirements and support to apply for an ISO 13485 audit.