Low-Risk Medical Devices in Mexico: No Sanitary Registration Does Not Mean No Regulatory Oversight
Low-Risk Medical Devices in Mexico: Exemption from Sanitary Registration Does Not Mean Exemption from Health Regulation
HEALTH REGULATION - COFEPRIS
Low-Risk Medical Devices in Mexico: No Sanitary Registration Does Not Mean No Regulatory Oversight
HEALTH REGULATION · MEDICAL DEVICES
For a company that manufactures, imports, or markets medical devices in Mexico, determining that a product does not require sanitary registration may appear to be the end of the regulatory analysis.
It is not necessarily so.
On July 7, 2025, an Administrative Agreement was published in Mexico’s Federal Official Gazette (Diario Oficial de la Federación, or DOF) updating the lists applicable to low-risk medical devices and to products that are not considered medical devices.
The instrument expressly distinguishes among:
products that do require sanitary registration;
low-risk medical devices that do not require sanitary registration; and
products that, because of their nature, characteristics, and intended use, fall outside the medical device category.
The distinction has significant practical consequences.
The absence of a sanitary registration requirement may represent regulatory simplification, but it does not necessarily mean the absence of health regulatory obligations.
Three Regulatory Scenarios That Should Not Be Confused
The current framework establishes three different categories, each producing distinct regulatory consequences.
1. Low-Risk Medical Devices That Still Require Sanitary Registration
Annex One includes devices classified as low risk that remain subject to sanitary registration in Mexico.
For these products, the 2025 Agreement establishes specific and simplified documentary requirements for obtaining registration and also differentiates certain requirements depending on whether the product is manufactured in Mexico or abroad.
Accordingly:
“Low risk” does not automatically mean “no sanitary registration required.”
Before structuring a market-entry or commercialization strategy, a company should determine whether the product actually falls within the applicable regulatory category and should not assume its status merely on the basis of a commercial perception of its risk level.
2. Low-Risk Medical Devices That Do Not Require Sanitary Registration
Annex Two includes medical devices classified as low risk that do not require sanitary registration.
However, the Agreement itself makes an important distinction: these products remain subject to Good Manufacturing Practices and medical device vigilance requirements.
This is the central point.
The exemption applies to one specific health authorization —the sanitary registration— but does not automatically eliminate other obligations that may apply to the product, the establishment, or the entities participating in its supply chain.
3. Products That Are Not Considered Medical Devices
Annex Three operates under a different legal rationale.
It covers products that, based on their nature, inherent characteristics, and intended use, are not considered medical devices because they do not fall within the categories established under Mexican health legislation.
For those products, the Agreement provides that they are not subject to sanitary registration or to an import permit under the medical-device regulatory regime for purposes of manufacturing, importing, conditioning, storing, distributing, or marketing them.
The distinction is important:
An Annex Two product remains a medical device.
It is simply exempt from sanitary registration.
An Annex Three product, by contrast, is not considered a medical device for purposes of that regulatory framework.
The two categories are not equivalent and should not be documented or treated as if they were.
Exemption from Sanitary Registration Does Not Eliminate Good Manufacturing Practice Requirements
For products included in Annex Two, the Agreement expressly maintains compliance with Good Manufacturing Practices (GMP).
At the date of the source analysis, NOM-241-SSA1-2025, Good Manufacturing Practices for Medical Devices, is in force.
A NOM (Norma Oficial Mexicana) is a mandatory Mexican Official Standard.
NOM-241-SSA1-2025 was published on April 4, 2025 and entered into force on November 30 of that year, replacing NOM-241-SSA1-2021.
Its scope includes establishments engaged in the manufacture of medical devices, as well as facilities involved in conditioning, warehousing, storage, and distribution for purposes of commercialization or supply in Mexico.
This changes the business question.
It is not enough to ask:
“Does my product require sanitary registration?”
The company must also determine:
“Which regulatory obligations continue to apply to my product and to the establishments involved in its manufacture, storage, or distribution?”
The specific scope of the NOM and the applicable GMP obligations must be determined according to the activities actually performed by each establishment.
Medical Device Vigilance Requirements Also Remain in Place
The Agreement expressly maintains medical device vigilance, known in Mexico as tecnovigilancia, for devices included in Annex Two.
At the date of the source analysis, NOM-240-SSA1-2012, Installation and Operation of Medical Device Vigilance, continues to be officially identified as in force.
A company should therefore not interpret exemption from sanitary registration as eliminating obligations associated with monitoring the safety and performance of devices after commercialization.
The regulatory logic is different:
the authority may determine that a product presents a sufficiently low level of risk not to require sanitary registration while, at the same time, maintaining obligations related to post-market safety and performance monitoring.
Importation: Regulatory Simplification, but Subject to Conditions
The treatment of imported Annex Two devices deserves particular attention.
Where those products are intended for commercialization in Mexico, the Agreement provides that they do not require an import permit to enter the country.
However, the benefit does not operate in isolation.
The importer must submit to Mexican customs authorities a declaration under oath (declaración bajo protesta de decir verdad) stating that the product falls within Annex Two and complies with Good Manufacturing Practices and medical device vigilance requirements.
In addition, the Agreement expressly provides that this simplification does not exempt the company from the obligations to maintain a Notice of Operation (Aviso de Funcionamiento) and a Responsible Sanitary Officer (Responsable Sanitario), where applicable.
The practical consequence is significant:
not requiring sanitary registration or an import permit does not mean importing without regulatory support.
The company must be able to substantiate both the regulatory classification used and the representations made for purposes of importing the product into Mexico.
Classification Must Be Based on the Actual Product, Not Merely Its Name
Before introducing or marketing a product under any of these categories, it is essential to review its specific characteristics.
It is not enough to find a similar product name in one of the regulatory lists.
The analysis should consider, among other elements:
nature and function;
indication or intended use;
technical characteristics;
presentation;
sterile condition;
interaction with other equipment or devices; and
any specific notes or conditions established in the relevant list.
The Agreement contains notes that may alter an initial classification conclusion.
One such note provides that sterile devices are not considered low-risk devices for purposes of the instrument.
As a result, relatively small technical differences may produce significant regulatory consequences.
Labeling: Particular Care Is Required During the Regulatory Transition
Medical device labeling requires a separate analysis because Mexico is currently undergoing a regulatory transition.
At the date of the source analysis, NOM-137-SSA1-2008, Labeling of Medical Devices, continues to be officially identified as in force.
The new NOM-137-SSA1-2025 was published on May 19, 2026, but Mexico’s official standardization platform continued to identify its status as “Pending”, with an effective date of May 14, 2027.
Accordingly, it would not be correct, at this stage, to treat NOM-137-SSA1-2025 as though it had already fully replaced the currently applicable labeling framework.
For companies, this means that any labeling strategy should consider both:
the requirements currently enforceable and the preparation required for the forthcoming regulatory transition when applicable to the product.
A Prior Exemption Letter May Not Resolve the Current Regulatory Analysis
Another issue requiring attention is the transition from the previous regulatory lists.
The 2025 Agreement repealed the instruments published in 2011 and 2014 and established transitional rules for certain products that had previously received an official exemption determination or exemption letter (oficio de excepción), but that are now included in Annex One and therefore require sanitary registration.
For those products, the Agreement established a transitional period for filing the corresponding sanitary registration applications, under a phased schedule based on the numbering of Annex One.
This means that a company should not assume that an exemption determination issued years ago necessarily continues to produce the same regulatory effects today.
The classification must be reviewed against the regulatory instrument currently in force.
The Risk of Confusing “No Registration” with “No Regulation”
A company may correctly conclude that a particular medical device does not require sanitary registration and still maintain an incomplete compliance strategy.
Depending on the particular product and operation, and to the extent applicable, the analysis may need to address:
regulatory classification;
establishment requirements;
Good Manufacturing Practices;
medical device vigilance;
importation;
labeling;
technical documentation;
warehousing and distribution;
advertising and commercialization; and
documentary evidence available in the event of regulatory scrutiny.
The regulatory analysis must address both the product itself and the operation behind the product.
That is the difference between merely determining whether a particular filing is required and developing a complete regulatory compliance pathway.
What Should a Company Review Before Commercializing the Product?
Before relying on an exemption from sanitary registration, a company should address at least the following questions.
Does the Technical Description Actually Match the Product Included in the Regulatory List?
Similarity in product names is not necessarily sufficient to determine classification.
Does the Product Retain the Characteristics Under Which It Was Included in the Relevant Category?
Changes in intended use, function, presentation, or sterile condition may alter the regulatory analysis.
Is It an Annex Two Medical Device or an Annex Three Product?
The legal consequences are different and should be documented correctly.
Which Obligations Continue to Apply to the Establishments Involved?
The manufacturer, importer, conditioner, warehouse operator, and distributor may each be subject to different obligations depending on their actual activities.
Is There Sufficient Evidence to Support the Regulatory Classification?
A company should be able to document why it concluded that a particular product was exempt from sanitary registration and identify the legal and regulatory provisions used to reach that conclusion.
Are the Currently Applicable Standards Being Considered?
The transition between NOM-137-SSA1-2008 and NOM-137-SSA1-2025 illustrates why regulatory effectiveness dates should be confirmed before implementing labeling or compliance changes.
SALGADO MARETTE Perspective
Mexico’s current framework for low-risk medical devices provides genuine mechanisms for regulatory simplification, but simplification does not mean deregulation.
The 2025 Agreement is particularly clear in maintaining Good Manufacturing Practice and medical device vigilance requirements for devices included in Annex Two, even though those products do not require sanitary registration.
For manufacturers, importers, and distributors, the analysis should therefore not end with the question:
“Does my medical device require sanitary registration?”
It must continue:
How is the product classified? Which obligations remain applicable? Which establishments participate in the operation? And what evidence does the company maintain to demonstrate that its chosen regulatory pathway is correct?
An appropriate market-entry and commercialization strategy requires distinguishing between the authorization applicable to the product itself and the broader set of obligations that accompany its manufacture, importation, storage, distribution, and post-market surveillance.
Eliminating one regulatory filing does not necessarily eliminate regulatory risk.