As discussed in our Classification and Grouping Ultimate Guide, the first step on classifying a product is to determine if it qualifies as a medical device in Mexico. A particular case is when products are considered Over the Counter Drugs or require a different type of licensing in other regions, but may fall under the medical device umbrella when analyzed under the Mexican regulatory framework.
Mouthwashes are one such category of products that often fall within this classification scope. While some mouthwashes may not necessitate a sanitary registration, it is essential to understand the nuances of their categorization under the Mexican medical device regulation to ensure compliance.
In this article, we will discuss both scenarios of the mouthwash classification, as well as the guidelines on their grouping when considered a medical device.
Mouthwashes as Medical Devices
Mouthwashes (also known as mouth rinses or oral rinses) can pose an awkward classification scenario if a proper assessment is not done. Specifically, it can be found in the list of products that are not considered medical devices. Nevertheless, it depends on the intended use and not solely on the product itself to conclude if the product is a medical device or not. In other words, mouthwashes can have various intended uses, including:
- Help cleaning debris after brushing.
- Reduce plaque.
- Kill bacteria.
- Help with the treatment of gingivitis.
- Hide bad breath.
- Slow tartar.
When analyzing if a mouthwash is considered a medical device, the intended uses associated with the product must answer if the product serves a therapeutic or medical purpose. If the answer is negative, then the product is not considered a medical device, and falls under item 690 of the list of products that are not considered medical devices. Therefore, it will not require a sanitary registration.
Conversely, if the intended use of the product fall under the therapeutic or medical usage, then the mouthwash is considered a medical device and must adhere to the medical device registration process in Mexico to obtain a sanitary registration.
As a rule of thumb, most mouthwashes that are not considered medical devices often include only an intended use of freshening the breath, without having any antibacterial or additional properties. In contrast, if the intended use includes the usage of active ingredients to help kill bacteria and reducing plaque, cavities or gingivitis, it is typically considered a medical device.
Classification and Grouping of Mouthwashes
Mouthwashes that are considered medical devices can be classified as Class I medical devices. Although some sanitary registrations may occasionally grant a low-risk medical device classification, a good practice is to gather the necessary information for a Class I device to fully adhere to the Mexican sanitary framework.
Regarding grouping, different variants of the same mouthwash can be included in the same sanitary registration, as long as they satisfy the following criteria:
- They have the same distinctive denomination (commercial name)
- They maintain the same active ingredients.
Minor differences in the ingredients are allowed between variants, as long as the active ingredient of the main formula is not different. The most common example of this scenario are different variants of the same product that only differ in color.
Classification of mouthwashes can be a delicate subject without the proper context. But often, a good and early assessment can save time on preparing the proper documentation for the corresponding registration procedure.
If you have any inquiries about the registration of mouthwashes or any other medical devices in the Mexican market, please feel free to contact us at firstname.lastname@example.org, or check our guidelines and checklists.