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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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:
- have a valid medical device licence
- be labelled according to the Medical Devices Regulations
Unlicensed medical devices have not had their safety and effectiveness assessed. This means they may pose a risk to the health of Canadians.
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.
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.
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.
Based on our review, 39 brands complied with the requirements.
The health and safety of Canadians is a shared responsibility between:
- industry
- health care professionals
- the federal government
- consumers
Industry
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:
- get a valid medical device establishment license (MDEL) to import and sell in Canada
- ensure the medical devices comply with regulatory requirements
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:
- using the health product complaint form (FRM-0317)
- calling 1-800-267-9675
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
You can check if a class II, III or IV medical device has a valid licence by:
- looking it up in the Medical Devices Active Licence Listing (MDALL)
- calling 1-800-267-9675
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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