Unlike other countries, in vitro diagnostics IVDs in Mexico are considered as medical devices and thus subject to general regulations and special rules for its classification and grouping. However, there is a specific standard that IVDs must accomplish in addition to other regulations, and we will explain it briefly in this text.
Background
The Official Mexican Norm NOM-064-SSA1-1993, establishing the sanitary specifications for reagent supplies for diagnostics was published in 1995 with the aim of establishing the minimum specifications that must be met by reagent supplies used as diagnostic agents in the measurements of components of medical interest in samples of tissues, fluids, excretions, and secretions of the human body, namely IVDs.
Even though NOM-064 is an almost 30 years old standard, COFEPRIS brought back its application as the only resource to evaluate IVD tests for detection of SARS-CoV-2 and diagnostic of COVID-19 even when newer international standards are available.
Content and scope
The most relevant sections of the NOM-064 are the definitions, specifications and test methods. It is worth mentioning that there is a section for labeling that matches the requirements of the NOM-137 about labeling for medical devices.
The scope of this Standard is for all companies involved in manufacturing, storage, distribution, importation and/or exportation of IVDs.
Specifications
In this section, all the specifications that must be evaluated in IVDs are listed as follows:
- Analyte (name, formulation)
- Measurement method (principle, references)
- Reagent supplies (components, presentation, ingredients)
- Standards and calibrators (concentration, purity, mixtures)
- Controls (positive, negative)
- Measurement instruments (type of determination)
- Quality specs (repeatability, accuracy, precision, sensitivity, stability)
- Instructions of use
Test methods
This section mentions the test methods to validate the results of quality specifications, including:
- Reproducibility for same batches
- Reproducibility for different batches
- Accuracy
- Sensibility (minimum concentration measurable)
- Specificity (interfering substances)
- Stability (chemical, physical, microbiological, and functional)
Conclusions
IVDs are considered medical devices in Mexico, even when the NOM-064 is outdated and not a well-known Mexican Official Standard, it is mandatory to comply in certain cases and COFEPRIS will use it as a resource for evaluating IVDs, as it happened during the COVID-19.
If you have additional questions about when and how to implement the NOM-064 for regulatory compliance in Mexico please contact us at contact@veraqueconsulting.com
