Considering the wide range of products within the medical device sector, it is necessary to differentiate them based on their risk level. In Mexico, the Ministry of Health categorizes medical devices as Class I, II, or III. Additionally, there is a sub-group known as Class I Low Risk, which is not a separate fourth class, but rather a sub-group of Class I devices. There are also products that are not subject to any sanitary control in Mexico, some of these non-regulated devices are identified through official lists.
This article provides detailed information about non-regulated products and guidance on how to identify them using these official lists. It also outlines the requirements in case your products fall under the Class I Low Risk. It is worth mentioning that Class I Low Risk devices follow a very simple regulatory process, making them a convenient option if you are looking to enter the Mexican market.
Agreements and requirements
As mentioned in our Ultimate Guide for Regulatory Affairs in Mexico, there is a legal framework to define the classification of medical devices in Mexico. Moreover, there are guidelines for the classification and grouping of any medical device according to its intended use and level of risk.
In addition to existing guidelines and regulations, the Ministry of Health published an updated official list on July 7th, 2025, identifying medical devices considered low-risk, as well as products that, based on their nature, characteristics, and intended use, are not classified as health supplies
This 2025 Agreement replaces the obsolete agreements from 2011 and 2014. One of its key improvements is the consolidation of both low-risk and non-regulated devices into a single document. Previously, these categories were distributed across separate annexes —one in each of the now outdated documents.
2025 Agreement – Annexes
- Annex 1: lists medical devices considered as low risk.
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- Some of the products listed include, among others: face masks, surgical clothing, external prostheses and simple wound dressings.
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- Annex 2: specifies products that do classify as Class I Low Risk medical devices but do not require a sanitary registration.
- Annex 3: lists products not considered as medical devices.
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- This annex includes 1984 products. Some examples included: TV systems (for operating rooms), rehab chairs, and immobilizers.
In summary, to find out if a product is considered a low-risk medical device, refer to Annex 1&2. To identify products not classified as medical devices, consult Annex 3 of the 2025 Agreement.
It is important to note that some products not listed in the annexes may still be considered Class I Low Risk or non-medical devices. In such cases, a careful classification assessment should be made with expert support.
Class I – Low Risk Medical Devices
Low-risk medical devices do require sanitary registration. However, compared to the regulatory processes for Class I, II, and III devices, the Class I Low Risk pathway is less intricated. The required documents are mostly administrative:
- Official application format
- Payment of fees
- Warehouse notice of the holder and distributor
- Power of attorney of the applicant
- Letter of authorization, issued by the manufacturer
- Instructions of use
In other words, at present the Class I low risk regulatory process does not require any technical report or study to be presented. Nevertheless, the Holder of these authorizations in Mexico must comply with local regulations (have a medical device warehouse, follow the technovigilance program, etc.). You can find more details about these requirements in the following article.
In case you need to confirm if your product is considered as a low-risk medical device or is not regulated by COFEPRIS please contact us at [email protected]