2015 to 2016 reporting on compliance monitoring: dermal fillers containing hyaluronic acid

We reviewed dermal fillers containing hyaluronic acid between 2015 and 2016. Learn about our findings and how we conducted our review.

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What are dermal fillers containing hyaluronic acid?

Dermal fillers containing hyaluronic acid are injected into patients in clinics and spas to reduce facial wrinkles.

These types of products are class III and IV medical devices. To be legally sold in Canada, they must:

Unlicensed medical devices have not had their safety and effectiveness assessed. This means they may pose a risk to the health of Canadians.

What did we do?

In the winter of 2015/2016, inspectors visited 40 clinics and spas across Canada. We examined 265 dermal fillers from 42 brands to verify if they were licensed and labelled appropriately.

What did we find?

Of the 265 products examined:

  • 3 dermal fillers were found to be unlicensed
  • 262 dermal fillers complied with the licensing and labelling requirements

This report is not intended to endorse any specific spa, clinic or brand of dermal filler.

What actions did we take to address non-compliant products?

We took action on 3 unlicensed Juvederm products manufactured by Allergan (France). They were labelled as:

  • Juvederm Ultra 2
  • Juvederm Ultra 3
  • Juvederm Ultra 4

The manufacturer confirmed that all 3 devices are diverted therapeutic products and are not intended for sale in Canada. The spa where the products were found committed to stop using these unlicensed devices.

What is a diverted therapeutic product?

Diverted products are manufactured by an authorized manufacturer for a specific market. However, these products end up being sold on a different market than intended.

Diverted products may not be stored, handled and distributed properly, and may not be safe or effective.

What products complied?

What are the shared responsibilities for health and safety?

The health and safety of Canadians is a shared responsibility between:

  • industry
  • health care professionals
  • the federal government
  • consumers


In Canada, manufacturers are responsible for the safety and effectiveness of their medical devices.

They must:

  • comply with the Food and Drugs Act and its regulations
  • get a medical device licence before advertising or selling any class II, III, or IV medical device in Canada
  • ensure all medical devices are properly labelled

Importers and distributors of medical devices must:

Health care professionals

Health care professionals, including those working in clinics and spas, should:

  • ensure the class II, III and IV medical devices they buy have been licensed for sale in Canada
  • purchase their medical devices only from importers or distributors with a valid MDEL

Health care professionals should report any problems or incidents related to the use of medical devices and other health products by:

Federal government

It's our responsibility to regulate the safety, effectiveness and quality of health products. This includes medical devices. Some of the ways we confirm that health products are meeting regulatory requirements, includes:

  • responding to complaints
  • examining products at the border
  • conducting inspections and market surveys
  • monitoring international information from other regulators, such as the U.S. Food and Drug Administration

We take action when a company or product isn't complying with Canada's regulatory requirements. Actions are based on the risk posed to Canadians.

Usually, we achieve compliance through a cooperative approach with industry. But, when needed to protect the health and safety of Canadians, we take appropriate actions, including:

  • recalls
  • public communications
  • seizures to remove product from the market

How do you identify a licensed product?

You can check if a class II, III or IV medical device has a valid licence by:

You should consult with your health care provider when considering an injectable cosmetic procedure. You should be aware of all of the potential risks and benefits of the procedure before getting treatment.

You should report any problems or incidents concerning medical devices and other health products through the health product complaint form (FRM-0317).

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