Free Guatemala medical device classification tool

What the Guatemala classifier checks

How are medical devices classified in Guatemala?

MSPAS uses a risk-based framework. Possible classes include IVDs: Categoría I — Bajo Riesgo, Categoría II — Mediano Riesgo, Categoría III — Alto Riesgo; Medical devices: Clase I — inscripción sin análisis (no estéril de uso externo), Clase II — inscripción con análisis (estéril de uso externo), Clase III — inscripción con análisis (no estéril de uso interno), Clase IV — inscripción con análisis (estéril de uso interno). In vitro diagnostic reagents have their own class axis, set by Norma Técnica Número 40 versión 3-2015 Art. 3, which classifies by sanitary risk taking into account knowledge, training, technology, analysis and the impact of the result. Category I is an enumerated low-risk list (culture media, colorants, diluents, buffers and lysing agents, wash solutions); Category II is a residual medium-risk category covering molecular biology, endocrinology, toxicopharmacology, blood chemistry, haematology, immunology, microbiology, copro-parasitology, coagulation, blood gases, urinalysis, immuno-haematology screening cells and self-testing; Category III is high risk (donor and transplant screening, immunological compatibility of blood, tissues and organs, and communicable diseases of high risk to the life of the general population, including rapid tests). Guatemala's own device class axis: Norma Técnica Número 37 versión 5-2016 classifies medical devices by use (in vivo) and by class, and Anexo 1 assigns the class from the combination of sterility and external or internal use. Class drives whether the inscription file goes for laboratory analysis, not which route it takes — there is a single Inscripción Sanitaria route for all four classes. The applicable class depends on the product's intended purpose, duration of use, invasiveness, active functions, implantability, sterility, software role, and other market-specific rules.

What information does the Guatemala classifier use?

Current official MSPAS classification requirements. Your result includes an explanation and links to the official sources used.

Is the result an official MSPAS classification decision?

No. The result is a preliminary estimate based on the product details you provide and the information available. Confirm the classification with the applicable authority or a qualified regulatory professional before filing.