Vigilance system implementation

Each medical devices manufacturer must establish a vigilance system, which is used in case of unwanted events on the market. Efficient reaction to vigilance cases, which also saves your good reputation in such situations, is of great importance. Let us advise you on how to set up a vigilance system that is going to keep you well prepared for any incidents caused by your products.

Contact us to find out more about the Vigilance system and to receive a quote.

Medical Device / IVD Classification

Medical devices classification can sometimes be very straightforward, but sometimes it can also be complicated. Uncertainties may appear whether your device is even a medical device or an in vitro diagnostic device, especially when dealing with the so called borderline products, or in which class of medical devices your device would fall. No matter how complicated the case, we can help you with your device classification. We can also obtain an official classification for your devices from the national competent authority.

EMA encourages patients to report suspected side effects

6 October 2014

As of 06th of October, European citizens can obtain information on suspected side effects, also known as suspected adverse drug reactions, of an additional 1,700 active substances contained in medicines approved in the European Union (EU) through a website maintained by the European Medicines AgencyExternal link icon (EMA).

The website launched in 2012 previously only contained information on suspected side effects reported with centrally authorised medicines. Its expansion now also allows the public to access the relevant information for medicines approved by national authorities in the EU.

Authorized Representative Service for CE Certified Devices

European authorized representative (EC REP) package is intended for companies that have already obtained the CE certificate for their devices or already compiled the technical file (for class I devices). In such cases, we only need to compile certain documents that we have to hold as your EAR (EC REP), review them, perform notification of your products to the competent authority, and act as your EAR, performing all of the functions of the EAR. If you already have the CE certificate then this package includes all the essential services that enable you to sell your products in the EU.

Instrucciones para el pago de tasas de la AEMPS: Cosméticos

Para el pago de tasas de los procedimientos más comunes relacionados con los cosméticos en la plataforma de pago de la Agencia Española de Medicamentos y Productos Sanitarios:

1. Acceder a la plataforma de pago: Acceda aquí a la plataforma.

2. Completar los datos del solicitante, sólo los datos obligatorios (*).

En caso de personas físicas el nombre debe coincidir con el del titular del certificado digital que realiza el pago.
3. Completar los datos de la tasas

Departamento: Departamento de Productos Sanitarios

Grupo: 08 De productos sanitarios, de cosméticos y de higiene personal

Tipo: Seleccionar el que corresponda

08.06 Licencia previa de funcionamiento de fabricación.
08.07 Licencia previa de importación.
08.05 Certificado de exportación.
08.08 Modificación de licencia de fabricación.
08.09 Modificación de licencia de importación
Número de actuaciones: 1 por cada procedimiento o producto

4. Pulsar AÑADIR

5. Solicitud de pago de tasas

6. Pago de tasas

7. Completar formulario de pago por cargo en cuenta o tarjeta de crédito: el titular del certificado digital debe corresponder con el titular de la cuenta o el apoderado (seleccionar pestaña en caso de apoderamiento)

8. Completar el pago con certificado digital

9. Esperar a que se cargue la pantalla de justificantes:

Para el interesado
Para la Agencia Española de Medicamentos y Productos Sanitarios
Para el Servicio de contabilidad de la Agencia Española de Medicamentos y Productos Sanitarios
Estos dos últimos se adjuntaran a la solicitud a presentar en la AEMPS.

Enlaces relacionados:

• Solicitud de certificados de cosméticos
• Cosméticos: Trámites administrativos 
• Declaración responsable para importar y/o fabricar cosméticos y productos de higiene personal.
• Declaración responsable: fabricación de cosméticos y productos de higiene personal
• CPNP Notification
• SAFETY ASSESSMENT (EU REGULATION 1223/2009)
• Importación de cosméticos

Fecha de actualización: 14-04-2015