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  • Writer's pictureArantza Meneses

Software as a Medical Device

The term Software as a Medical Device or SaMD was defined by the International Medical Device Regulators Forum as software created to be used for one or more medical purposes without being part of the hardware in the medical device, including mobile applications that meet the definition. This concept can also be found officially in NOM-241-SSA1-2021, good manufacturing practices for medical devices.


SaMD can be classified into four main categories (I, II, III, IV) according to their impact on patient care.

  • Category I: is software capable of collecting symptom data to calculate the likelihood of some disease or programs capable of analyzing images to make all kinds of diagnoses.

  • Category II: are analytical programs that can analyze data to predict the risk of some disease, such as analyzing heart rate to predict the risk of heart disease, and can also integrate and analyze tests to propose diagnoses.

  • Category III: includes software capable of detecting interrupted breathing using a smartphone microphone.

  • Category IV: includes programs that can perform diagnostic image analysis. Also, those that can create structural maps of lesions with possible growth patterns or those designed to combine data to search for the presence of pathogens.


Although they can sometimes present cybersecurity risks that should not be taken lightly and there are still difficulties to overcome, the advantages of SaMD are becoming increasingly apparent. Not only do they enable professionals to provide personalized and timely care, but they also help improve the delivery of care while reducing costs and improving outcomes.

Some of the benefits that software as a medical device offers both physicians and patients are:

  • Improve detection and diagnosis, make it easier to provide personalized treatment plans for patients, and reduce the time from diagnosis to treatment.

  • SaMD systems can be used with wearable sensors that collect vital signs, allowing patients to monitor their conditions better and identify triggers.

  • There are applications that facilitate the management of chronic diseases and conditions by tracking data and adjusting treatments on the fly.


As with any medical device, regulation is necessary for risk containment. In the case of the SaMD, there are several unknowns about how it should be validated and what regulatory information should be submitted for its sanitary registration. These doubts can be resolved with the current NOM-241-SSA1-2021 since so far it is the only official document that mentions and addresses software as a medical device.

Within the quality information requested for the registration of these apart from the legal information it is necessary to address the chemical and technical part in which three requirements stand out:

  1. Clinical evaluation.

  2. Analytical validation was carried out in accordance with section 11.17 of NOM-241.

  3. Clinical validation.

COFEPRIS has convened a group of specialists to review the concept of SaMD and its regulatory implications, such as its inclusion in the regulatory framework, its correct definition, its correct homologation, and the updating of the applicable rules and regulations.

There is a long way to go regarding its regulation, but its benefits are palpable and its applications are infinite. Without a doubt, SaMD improves the quality of the medical care provided and increases the profitability of these services.

If you are interested in knowing more about this topic contact us, we have a lot of experience in the development of Medical Device Software.

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