Overview of December 2025 Regulatory Changes in Mexico
- Low risk Medical Device listing, application criteria as per the Q&A document from COFEPRIS
- Tariffs
- COFEPRIS Commisioner (Head of COFEPRIS)
- COFEPRIS new prices
COFEPRIS Finalized Criteria for Low-Risk Medical Devices
The criteria as to how the new listing for medical devices that are considered low risk and therefore are either free of premarket authorization, or do require it while remaining low risk has already been finalized and was presented to the industry as a Q&A through the chamber for the industry (CANIPEC). COFEPRIS provided a link to the final document:
Structure of the Low-Risk Medical Device Listing
Before mentioning the criteria, this listing of low risk medical devices has three annexes:
- Annex One for low risk medical devices that do need premarket authorization. This is a new annex.
- Annex Two for low risk medical devices that do not require premarket authorization.
- Annex Three for products that are not considered either medical devices or pharmaceuticals so they are commodities and not pharma.
Therefore it is understood that any product with medical action or claims, that is not mentioned in the listing can be considered a pharmaceutical. Because the understanding has to be valid for the authority, a list of application criteria as Q&A for the industry and the authority was created.
Product Classification Clarifications from the COFEPRIS Q&A
Important points from the final Q&A are:
For toothpaste and mouthwash:
As long as they remain complaint with the limits for the ingredients contained in the Listing for Cosmetic Ingredients and make no claim that can be understood as medical or pharmaceutical in the name, images, product claims, or marketing; they can remain as cosmetics. It is important here to remember that claims such as “whitening”, “plaque removing/ preventing”, “calcifying”, “preventing/reducing cavities”, “bacteria/microorganism control, etc.” can all be understood as pharmaceutical and cannot be used for a cosmetic toothpaste, or a cosmetic mouthwash.
If these products do make medical claims, they will not need premarket authorization but will be considered as a low risk medical devices, requiring GMP for medical devices, labeling as medical devices and for import, and the importer in Mexico to have a Technovigilance unit, plus a sworn letter from the importer stating the product does not require premarket authorization as is indicated in the listing.
If they are cosmetics, then they must be labeled as cosmetics with the Certificate of compliance from an authorized certification unit (UVA), and a letter containing the sworn statement from the importer that they are cosmetics. Cosmetic GMP certificate is not required for import. As to the sworn statement, the best option is to get a letter of classification from COFEPRIS accepting the product as a cosmetic.
Shampoos for dandruff and other antidandruff products:
These were indicated specifically as cosmetics when they complied with the cosmetic ingredient limits and medical devices if not or if they carried a prevention or therapeutic/medical claim, and were totally removed from the listing. As per the criteria, as long as they still comply with the cosmetic ingredient listing and make no medical claims they can still be considered cosmetics. But if they are not, then they are considered as drugs/ medication. Antidandruff products are no longer classifiable as medical devices.
In practice this translates into considering a letter from COFEPRIS stating the proper classification of the anti dandruff product when it can be considered as a cosmetic, as a good practice and totally recommended to avoid delays at customs or during inspections. If they are cosmetics, then they must be labeled as cosmetics with the Certificate of compliance from an authorized certification unit (UVA).
For pharmaceutical dandruff products, the process will be same as for other pharmaceuticals.
Software for medical devices:
Prior to the Q&A there was some confusion on whether medical application software is or is not a medical device and whether it requires premarket authorization independently from the medical device.
As per the Q&A criteria, software that is required for the functioning of a medical device and is part of the equipment does not need premarket authorization on its own, as it is considered as part of the equipment authorized as a medical device.
Software that is used to evaluate the performance of equipment or that is developed to analyze and interpret medical data, especially for following epidemics but is not a necessary part of the equipment is not a medical device either, as per the listing.
Items that change classification as per this new listing
Most of the items from the previous listing remain the same, but some may change classification and now require a premarket authorization, as another class of medical device or as pharma.
If this happens, the time for getting the premarket authorization is three years.
New Import Tariffs Effective January 1, 2026
On December 29 the new import tariffs for several items imported to Mexico from countries that do not have free trade agreements were published, and they came into effect on January 1, 2026.
As per the document, the new higher tariffs are general, but will not be applied to countries that already have free trade agreements with Mexico.
Among the interesting items, the new higher import tariffs are for:
| ITEM | NEW IMPORT TARIFF |
| Cosmetics (except lipsticks) | 25% |
| Lipsticks | 36% |
| Dental hygiene products (toothpaste, and dental floss) | 30% toothpaste, 25% dental floss |
Other items are plastic parts such as threads and tubes, some construction materials such as windows, fabrics, shoes, and toys.
Pharmaceuticals and food supplements or foods in general are not included.
The link to review and download the publication is here.
Leadership Change at COFEPRIS
Head of COFEPRIS
On January 1st. it was announced that COFEPRIS has a new Commisioner. The Federal Commissioner for the past year, Dr. Armida Zuñiga left and now Dr. Victor Hugo Borja Aburto is the new Federal Commisioner.
As to what to expect, the new Commisioner has been head of Instituto del Bienestar (INSABI) which went broke under his direction, but has a long record of working in the public healthcare system in other areas.
The change was dictated by the Health Ministry in order to make COFEPRIS a more efficient entity, so for now and given the COFEPRIS vacation period for end of 2025 is basically coming to an end tis week, we will see how this change in Commisioner works.
Updated COFEPRIS Government Fees for 2026
New government tariffs for COFEPRIS authorizations and permits.
As happens every year, the COFEPRIS tariffs for reviewing and if acceptable, giving permits such as import permits, or marketing materials permits; for certificates such as free sale, or GMP, and for authorizations such as operation licenses for pharmaceutical manufacturing facilities and premarket authorizations for medicines and for medical devices; have been updated for 2026. The updated cost remains for all of 2026, and for any and all submissions presented by the end of 2025 and paid with the 2025 fee there is no need to make an extra payment or to update the amount paid. For any submission presented in 2026 the new fees will apply.
Also, for service quotes involving COFEPRIS payments, the fee to consider is the 2026 one. The link to these is on this site.
COFEPRIS Submission Portals and Administrative Process
Even though the fees have changed the submission portals for digital submissions and for downloading formats for submissions made at the window remain the same.