How are medical devices and cosmetics with CBD regulated in Switzerland?

In April 2024, Swissmedic updated a guidance document on products containing cannabidiol (CBD) and other cannabinoids that are not subject to narcotics legislation, with particular attention to medical devices and cosmetics.

Medical devices with CBD and other cannabinoids

In the case of medical devices with CBD and other cannabinoids, Article 15 of the MedDO together with Annex VIII of EU Medical Devices Regulation (MDR) guides the classification.

In the classification assessment of products with pharmacologically active or psychoactive substances, manufacturers must verify whether the product is a medical device or a medicinal product. Essentially, when a product with medical intended purpose contains CBD or other cannabinoids that are supporting the mode of action and the primary effect is not achieved  by pharmaceutical, immunological, or metabolic means, the product can be classified as a medical device.  Generally, classification rules 14 and 21 of the MDR apply to such medical devices. As for all medical devices, manufacturers must follow the appropriate conformity assessment and be able to demonstrate compliance with the fundamental safety and performance requirements. Under rules 14 and 21, the involvement of a notified body is also necessary.

Cosmetics with CDB and other cannabinoids

Switzerland applies the Single Convention on Narcotic Drugs under its national narcotics legislation. In this sense, none of the intermediate products during the cosmetics manufacturing process can have a THC content of more than 1.0%, regardless of whether the substance was obtained from the flowers or leaves of the hemp plant. If the content is higher, the provisions of narcotics legislation apply to the product.

Brand-owners must be aware that the safety report of the cosmetic product must include scientific evidence that the CBD or other cannabinoids do not pose a risk to health and are safe.

Lastly, the Swissmedic guidance points out that many CBD oils presented as oral care products containing various concentrations of CBD have been found on this Swiss market. Such products are not cosmetics and do not comply with the intended use of a cosmetic product. Moreover, according to the Swiss authorities, there is not sufficient data supporting the safety of such products at this stage.

Do you want to know more on how to sell medical devices or cosmetics in Switzerland? Contact us.

Simona Varrella

Expert Consultant of Regulatory Intelligence & Innovation department

16.4.2024

Are you interested in selling your medical devices or cosmetics in Switzerland? Obelis can act as your Swiss Authorised Representative and turn your Swiss journey into a success story! Contact us today.