• Article Index

• Interpret FDA's QSR

• Find Regulatory Requirements for your country
• GHTF
• Validation Requirements
• Medical Device Software
• Sterilization

• FDA Requirements
• European Union Requirements
• Canadian Requirements

Medical Device Knowledgebase

Health Canada and Medical Devices Related Questions

• How does Health Canada define a "medical device"?

• What is the Canadian Medical Devices Bureau of the Therapeutic Products Directorate (TPD)?

• Does the Canadian TPD work in identical ways to the FDA?

• What are the national and international standards and guides currently used by TPD and Registrars?

• How does Health Canada define “Manufacturer”?

• What is a CMDCAS recognized registrar?

• I’m a distributor that imports devices into Canada. Do I need to certify to ISO 13488/13485?

• I’m a manufacturer of a Class I device – do I require a device licence? An establishment licence?

• How do I go about getting a Medical Device Establishment Licence (MDEL) from Health Canada?

• Does our Health Canada Device License every expire?

• Our Health Canada Medical Device License was cancelled?

• Where can I get information related to renewing my Health Canada Medical Device License?