How Health Canada inspects medical device establishments: Assessing compliance with the Food and Drugs Act

If you manufacture, advertise or sell medical devices, certain sections of the Food and Drugs Act (the Act) apply to you. These sections are highlighted here to help you understand how inspectors assess your compliance with the Act. Inspectors look to see whether you are engaged in any activity the Act forbids. This is important since you are responsible for meeting the requirements of the Act.

Part 1: Food, drugs, cosmetics and devices

Section 3: Prohibited advertising and sales

Subsections 3(1) and 3(2) forbid you from advertising and selling medical devices to the general public if the devices are labelled or presented as a treatment, preventative or cure for any of the diseases, disorders and abnormal physical states listed in Schedule A.1 of the Act.

Section 19: Prohibited sales of devices

Section 19 forbids you from selling any device that may injure the health of the buyer or user when used as directed or under customary or usual conditions. No company shall sell a device that poses a health hazard.

Section 20: Deception regarding devices

Subsection 20(1) forbids you from labelling, packaging, treating, processing, advertising or selling a device in a manner that:

When Health Canada issues a medical device or a medical device establishment licence (MDEL), it does not mean we approve of the device or the company. It only means that we authorize you to import or sell the device in Canada.

Advertising medical devices with claims that the device or company is “approved by Health Canada” or with displays of the Health Canada logo are not permitted. Under subsection 20(1), advertisements with these claims are considered misleading since they create an incorrect or mistaken impression about the device’s merit or safety.

Subsection 20(2) forbids you from labelling and packaging devices unless they meet the requirements of the Regulations.

Section 21: Where standard prescribed for device

Section 21 forbids you from labelling, packaging, selling or advertising any article in such a way that it could be mistaken for a device. The exception is if the article meets the prescribed standard for that device.

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