This medical device supply agreement is an agreement that allows the buyer to purchase certain products to be used in the manufacture of its own medical products. The supplier will manufacture, purchase, or assemble the components and sell them to the buyer for use in manufacturing those medical products.
Para su conveniencia, debajo del texto en español le brindamos la versión completa de este formulario en inglés. For your convenience, the complete English version of this form is attached below the Spanish version.Suffolk New York Acuerdo de suministro de dispositivos médicos - Medical Device Supply Agreement
State:
Multi-State
Category:
County:
Suffolk
Control #:
US-TC0613
Format:
Word
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El etiquetado incluye la etiqueta, las instrucciones de uso y la informacion relacionada con la identificacion, la descripcion tecnica, la finalidad prevista y el uso correcto del dispositivo medico y el DMDIV, segun corresponda (figura 1).
Los dispositivos medicos son un componente fundamental de los sistemas de salud; son esenciales para prevenir, diagnosticar, tratar y rehabilitar enfermedades de una manera segura y eficaz.
Para efectos de registro, los dispositivos medicos se clasifican segun el grado de riesgo que representan, el cual se evalua segun el tiempo de contacto con el organismo humano, el grado de invasividad, si libera medicamentos para el paciente, si se utiliza combinado con otro medicamento o dispositivo.
Nombre del producto. Numero de lote o serie. Fecha de expiracion cuando sea el caso. Numero del registro sanitario o permiso de comercializacion.
Agentes de diagnostico: Todos los insumos incluyendo antigenos, 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 clinicos o paraclinicos.
Los Dispositivos Medicos incluyen a los Insumos para la salud de las siguientes categorias: equipo medico, protesis, ortesis, ayudas funcionales, agentes de diagnostico, Insumos de uso odontologico, materiales quirurgicos, de curacion y productos higienicos.
Permiso de Comercializacion para Equipo Biomedico de Tecnologia Controlada: Es el documento publico expedido por el Invima, previo al procedimiento tendiente a verificar el cumplimiento de los requisitos tecnico-legales establecidos en el presente decreto, el cual faculta a una persona natural o juridica para producir,
La correcta regulacion de los dispositivos medicos garantiza el acceso a productos de alta calidad y eficaces; ademas, asegura beneficios a la salud publica y la seguridad de pacientes, trabajadores de la salud y comunidades.
Para efectos de registro, los dispositivos medicos se clasifican segun el grado de riesgo que representan, el cual se evalua segun el tiempo de contacto con el organismo humano, el grado de invasividad, si libera medicamentos para el paciente, si se utiliza combinado con otro medicamento o dispositivo.
Regla 1: Todos los dispositivos medicos no invasivos pertenecen a la clase I, excepto que sea aplicable alguna de las siguientes reglas: Corresponden a dispositivos medicos que no tocan al paciente o solo se contactan con la piel sana.