Determining Medical Device Classification in Mexico

WoodDuck

Starting to get Involved
#1
Hello,
I'm trying to find out if a product my company sells in USA would be considered a medical device in Mexico. Not being fluent in Spanish has made this simple task a bit daunting. Is there information on the COFEPRIS web site? The product is a patient harness that would be used to prevent a fall if the patient were to loose ones balance. It is not intended to be used with a patient hoist of any other lifting device. Any assistance would be welcome. :cfingers:
 
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QAMTY

#3
WoodDuck
Look at this address ,http://www.gob.mx/cofepris/AS, into it
do a search "dispositivos medicos", I found such information.

this is an extract of a pdf document.
DEFINICIONES:
Para efectos del presente documento y la correcta clasificación del dispositivo médico se tienen las siguientes
definiciones:
1. Categorías de Dispositivos Médicos. Son los 6 grandes grupos en los cuales se divide al sector de los
dispositivos médicos en México con base a su función y finalidad de uso. Estas categorías se definen
como:
I. Equipo médico: Son los aparatos, accesorios e instrumental para uso específico destinados a la
atención médica, quirúrgica o a procedimientos de exploración, diagnóstico, tratamiento y
rehabilitación de pacientes, así como aquellos para efectuar actividades de investigación biomédica.
II. Prótesis, órtesis y ayudas funcionales: Aquellos dispositivos destinados a sustituir o
complementar una función, un órgano, o un tejido del cuerpo humano.
III. Agentes de diagnóstico: Todos los insumos incluyendo antígenos, anticuerpos calibradores,
verificadores o controles, reactivos, equipos de reactivos, medios de cultivo y de contraste y
cualquier otro similar que pueda utilizarse como auxiliar de otros procedimientos clínicos o
paraclínicos.
IV. Insumos de uso odontológico: Todas las sustancias o materiales empleados para la atención de
la Salud dental.
V. Materiales quirúrgicos y de curación: Los dispositivos o materiales que adicionados o no de
antisépticos o germicidas se utilizan en la práctica quirúrgica o en el tratamiento de las soluciones
de continuidad, lesiones de la piel o sus anexos.
VI. Productos higiénicos: Los materiales y sustancias que se apliquen en la superficie de la piel o
cavidades corporales y que tengan acción farmacológica o preventiva.
2. Clasificación de Dispositivos Médicos. Los Dispositivos Médicos se clasificarán para efectos de registro
de acuerdo con el riesgo que implica su uso, de la manera siguiente:
• Clase I: Aquellos insumos conocidos en la práctica médica y que su seguridad y eficacia están
comprobadas y, generalmente, no se introducen al organismo.
• Clase II: Aquellos insumos conocidos en la práctica médica y que pueden tener variaciones en el
material con el que están elaborados o en su concentración y, generalmente, se introducen al
organismo permaneciendo menos de treinta días.
• Clase III: Aquellos insumos o recientemente aceptados en la práctica médica, o bien que se
introducen al organismo y permanecen en él, por más de treinta días.

Maybe your device, may fall in type II device.
I also attached a pdf file which was downloaded form that site
Fell free to contact me if you need more information
hope this helps
 

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