Who regulates period products in Canada, and elsewhere

In Canada, a tampon and a period pad can sit on the same shelf and come under different laws. Health Canada says tampons “are regulated as medical devices”. Cups and discs are medical devices too. Period pads, liners and period underwear are consumer products. The difference is about which rules apply. It is not a ranking of formats, and it says nothing about which one suits you.

Canada, format by format

This table first appeared in our Column on absorbency labels. It is repeated here without the absorbency column, and with one row reworded: reusable period pads.

Here is what each row means, in the house’s fixed order.

Period pads & liners. These are not medical devices. Employment and Social Development Canada (ESDC) says menstrual pads “aren’t medical devices”. As consumer products, they come under the Canada Consumer Product Safety Act. Disposable period pads are made for one-time use, so textile labelling rules do not apply to them.

Tampons. Health Canada says it “makes sure that the tampons sold in Canada are safe, effective, and of high quality based on requirements for licensing, quality manufacture, and post-market surveillance.” Before a licence is given, the package label must carry absorbency information and details about the risks and symptoms of TSS. The statement below is required on the outer label.

Cups. Health Canada’s keyword index lists “CUP, MENSTRUAL” as a Class 2 device. Health Canada’s labelling guidance has two product appendices, for contact lenses and for tampons. It has none for cups. That is about label wording, not about risk. A 2020 recall, described below, is one example of the licence rule being applied to a cup.

Discs. The keyword index has no entry for discs by name. The evidence is the licences themselves: Health Canada’s public licence list shows reusable and single-use menstrual discs under Class 2 licences.

Period underwear. Period underwear is a consumer product. The Textile Labelling Act also applies. It covers products “made in whole or in part from a textile fibre” sold to consumers, and its regulations list “undergarments”. That means fibre-content labelling.

Reusable period pads. The table gives them the same two laws. The textile labelling part is still to be confirmed, which is why the row carries a note.

Comfort & care. This shelf is not in the table. Some comfort items are medical devices in Health Canada’s index, and others are consumer products. Each item is classed on its own.

Why the split? The Canada Consumer Product Safety Act “applies to consumer products with the exception of those listed in Schedule 1”, and Schedule 1 lists “Devices within the meaning of section 2 of the Food and Drugs Act”. So tampons, cups and discs come under device rules, and period pads, liners and period underwear come under consumer-product law.

A note on words: some sources we cite here say “menstrual pads”, “sanitary towels” or “feminine hygiene products”. We keep each source’s words so we report it accurately. In our own words, we say “period pads”. The Reading Room is for everyone who menstruates.

What “licensed” means

Health Canada sorts medical devices by risk. In the regulations’ words: “Medical devices are classified into one of Classes I to IV… where Class I represents the lowest risk and Class IV represents the highest risk.” Tampons, cups and discs are Class II.

For Class II to IV devices, the regulations say “no person shall import or sell” the device “unless the manufacturer of the device holds a licence in respect of that device”. Three things follow from that sentence. The licence belongs to the manufacturer. It covers a specific device. And the rule binds everyone who imports or sells the device, not only the maker.

In plain words, a licence is Health Canada’s permission for a manufacturer to sell a specific device in Canada. Health Canada’s own list calls it being “authorized for sale”. A licence is permission to sell. It is not a ranking, and it is not a recommendation of one product over another. We use the regulator’s word, “licensed”, and not “approved”.

Licences can also end. Some menstrual device licences have been cancelled or have end dates. That is why the table says “must be licensed”, not “are licensed”.

How to look up a licence yourself

Health Canada keeps a public list called MDALL, the Medical Devices Active Licence Listing. Its own description: “Your reference tool for licensed medical devices in Canada.” Anyone can search it. Here is how.

1. Open MDALL at health-products.canada.ca/mdall-limh and choose “Active Licence Search”.
2. Pick one search option. MDALL takes one at a time: “Company name”, “Licence name”, “Device name”, “Company ID”, “Licence number” or “Device identifier”.
3. Type your term in “Search for”. If a licence number is given on a package or in the instructions, search it as “Licence number”. MDALL returns the exact number match.
4. No result? Try the “Archived Licence Search”. It searches by licence number, device name or device identifier only. There, “Products that are no longer authorized for sale in Canada are listed in red and with an asterisk.”

An active result tells you that a licence for that device is active on the day you search. It does not tell you whether the product will suit you.

Recalls, and reporting a problem

The Government of Canada posts recalls on one site, “Find recalls, advisories and safety alerts” (recalls-rappels.canada.ca). It has a search box. You can also “Receive emails about new and updated recall and safety alerts.”

To report a problem, the same site offers this: “Report an incident: Notify us about side effects, injuries, health and safety concerns related to any product.” Health Canada’s tampon page also links to a page to “Report any problems with tampons, including cases of suspected Toxic Shock Syndrome”.

Here is one example of a recall. In 2020, a notice concerned a reusable menstrual cup sold in Canada without a licence. It said: “Sale of an unlicensed class II, III or IV medical device in Canada is a violation of section 26 of the medical devices regulations.”

If a product worries you because of how you feel, start with a healthcare provider. The signs of TSS are set out in “TSS: the facts, calmly”. In an emergency, call 9-1-1.

Elsewhere: the same products, other rules

Readers in Canada also read pages from the United States, the United Kingdom, Europe and Australia. Their rules differ, and none of them applies in Canada. Each regulator is quoted below in its own words, with the date of its page. The Editor gives no opinion on which system is better.

In the United States, the Food and Drug Administration (FDA) says: “All menstrual products marketed in the United States are subject to regulation by the FDA as medical devices.” On its page, that includes period pads, liners and period underwear.

In Great Britain, the Medicines and Healthcare products Regulatory Agency (MHRA) lists “feminine hygiene products (sanitary towels, tampons)” among “products that are not normally considered to be medical devices”.

In the European Union, the Editor found no regulator’s own sentence about period products. The industry association EDANA says: “tampons must comply with the General Product Safety Regulation (2023/988/EU).”

In Australia, a tampon standard made under the Therapeutic Goods Act says “tampons means therapeutic goods that are menstrual tampons”. A separate determination lists “menstrual pads other than tampons and menstrual cups” among excluded goods.

The plate below sets these side by side.

What this is not

This Column described rules, in the regulators’ own words. It is not legal advice. It did not rank formats or compare brands. A licence, a class or a law says which rules apply to a product. It does not say which product suits you. Two people with the same flow choose differently, and both are right.