Classification of products for moxibustion: Notice to stakeholders

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This notice is to inform stakeholders of the classification of products used for moxibustion.


Moxibustion is a focused topical heat therapy. It involves burning a bundle of Mugwort plants, also known as moxa, to generate heat over specific body areas.

Health Canada held internal and external consultations to determine the classification of products used for moxibustion. Consultations were held between December 2020 and April 2021 with the following groups:

We wanted to understand the potential risks associated with the sale and use of products used for moxibustion.

The comments we received indicate that products used for moxibustion present a low risk to people.

Classification decision

Health Canada has determined that products for moxibustion are non-invasive medical devices. As such, they fall under Rule 7(1) of Schedule 1 of the Medical Devices Regulations (MDR) and are classified as Class I devices.

However, moxa products that are not used for moxibustion are still classified as natural health products.


Manufacturers, importers and distributors of products used for moxibustion must comply with the requirements of the MDR for Class I medical devices. They must obtain a medical device establishment licence (MDEL) to sell, import or distribute products for moxibustion in Canada, as per section 44 of the MDR.

For more information on how to obtain an MDEL:

Additional information

This notice only applies to products used for moxibustion.

For information on the classification of medical devices, drugs and natural health products that do not readily fall within the definition of 'device' or 'drug' under the Food and Drugs Act, please consult the following guidance documents:

Contact us

For questions about the classification of products at the medical device-drug interface or the regulatory framework that may apply to a particular health product:

For questions about the classification of a product that may be considered a natural health product:

For more information on this notice:

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