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The region of Valencia is the first to have its tourism sustainability strategy certified by AENOR
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Find the right course for you at AENOR
Curso WSSP01 Comercialización de productos sanitarios
Live Training
Download the programme
REGISTER NOW
FUNDAE allowance
General Information
Invitation Dates
Formats
La crisis sanitaria provocada por el SARS-CoV-2 ha generado en el mercado español una demanda muy por encima de la habitual de determinados productos sanitarios como, por ejemplo, mascarillas quirúrgicas, guantes, test de diagnóstico in vitro, termómetros, etc.
En España, la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) es la responsable de la verificación de estos requisitos en el momento de la importación de los productos. Esta verificación se realiza en la llegada de la mercancía a la aduana, mediante el control que llevan a cabo los servicios de inspección de las áreas funcionales de Sanidad de las delegaciones del Gobierno.
Según el procedimiento habitual, se debe cumplir una serie de requisitos para autorizar la importación. Los productos deben poseer el marcado CE, haber seguido el procedimiento de evaluación de la conformidad correspondiente y que el importador disponga de licencia previa de funcionamiento como importador. Asimismo estos productos deben darse de alta en el registro de comercialización de la AEMPS y en la base de datos europea EUDAMED.
Este curso proporcionará al participante información detallada sobre cómo importar y comercializar productos sanitarios en España. Se hablará del marco legislativo en la Union Europea, comentando cuales son los puntos en común en el mercado UE pero hablando específicamente de los requisitos que marca el mercado español. El curso hará hincapié en los pasos para importar, certificados requeridos, de acuerdo a la legislación vigente. El curso ayudará a los participantes a iniciarse en el proceso de importar productos sanitarios de países extracomunitarios.
Intended for
Business professionals interested in starting to import or export healthcare products; technical staff and professionals in manufacturing or importing companies. Quality managers.
Special promotion
*Discounts cannot be combined.
Objectives
Learn about the legal requirements in Spain and, more generally, in the European Union for importing or exporting healthcare products.
Study in detail the steps that need to be taken and the requirements for importing.
Obtain practical guidance for the clear implementation of these requirements.
Content
Overview
of the legal and legislative framework regarding the marketing of healthcare products in Spain and the European Union (Regulation (EU) 2017/745 on healthcare products, Royal Decree 1591/2009 regulating healthcare products, etc.), with consideration of new legislation on healthcare products.
What are the steps for importing healthcare products?
What are the requirements for imports to be authorised?
Extraordinary import authorisations in exceptional situations: what are these situations? how do we guarantee that products are safe to use?
Legislative requirements to be taken into account in order to export healthcare products from Spain.
Case study / Answers to practical questions
This course will include interactive discussion sessions and practical exercises
Live Training/Streaming
Aula virtual
17/06/2025 - 18/06/2025
410
+ IVA 21%
Register
Detailed information
Description of format
AENOR offers you all the technologies and resources you need to continue with your training plans and build your future. AENOR has created LIVE TRAINING
via streaming
so you can attend the course remotely from work, home or wherever.
The courses are taught on a tele-training platform with the simultaneous presence of teachers and students interacting in the Virtual Classroom throughout the training session.
During the duration of the course, the teacher presents the subject by videoconference, with practical examples and taking into account the students' queries and questions.
The teacher combines theory classes with collaborative team activities, which gives students the opportunity to learn and acquire knowledge with the same quality as in-person training.
The best LIVE training from wherever you want with the best teachers.
Classes 100% LIVE
.
Schedule
2 days - 7 hours. From 2.30 pm to 6.00 pm.
Dates: 17/06/2025 - 18/06/2025
Live Training/Streaming
AENOR offers you all the technologies and resources you need to continue with your training plans and build your future. AENOR has created
LIVE TRAINING
to allow students to attend the course remotely from home or work.
The courses are taught on a tele-training platform with the simultaneous presence of teachers and students interacting in the Virtual Classroom throughout the training session.
During the duration of the course, the teacher presents the subject by videoconference, with practical examples and taking into account the students' queries and questions.
The teacher combines theory classes with collaborative team activities, which gives students the opportunity to learn and acquire knowledge with the same quality as in-person training.
The best LIVE training in your own home with the best teachers.
Classes 100% LIVE
.
Duration, schedule
2 days - 7 hours. From 2.30 pm to 6.00 pm.
Price
€410 (Taxes not included)
Live Training/Streaming Invitations
Aula virtual
17/06/2025 - 18/06/2025
410
+ IVA 21%
Register
REGISTER NOW
FUNDAE allowance