Spain Medical Device Registration

Agencia Española de Medicamentos y Productos Sanitarios

https://www.aemps.gob.es/?lang=en

Medical devices; Medical devices; In vitro diagnostic medical devices; Active implantable medical devices; Breast implants; Clinical investigations with …

Medical Device registration in Spain - Thema Med

https://www.thema-med.com/en/medical-device-registration-in-spain/

Medical Device Registration in Spain In the case of a non-European manufacturer it is necessary to appoint a European Authorized Representative. CE-marked Class I Medical …

Spain Medical Device Registration

https://arazygroup.com/medical-device-registration-spain/

Spain Medical Device Registration - AEMPS Approval | LICENSALE® Medical Device …

Spain - Medical Equipment & Devices - International …

https://www.trade.gov/country-commercial-guides/spain-medical-equipment-devices

MORE FREQUENTLY USED SERVICES - Agencia …

https://sede.aemps.gob.es/en/procedimientos-y-servicios/tramites-mas-usados.html

MORE FREQUENTLY USED SERVICES ELECTRONIC FEE PAYMENT HUMAN MEDICINES (*) In case of applications without digital signature, it is necessary to send to …

Things You Should Know When Registering …

https://www.regdesk.co/things-you-should-know-before-registering-your-medical-devices-in-spain/

Things You Should Know Before Registering Your Medical Devices in Spain. Jan 19, 2019. The institution responsible for medical device regulations in Spain is …

Medical Device Registration in Spain

https://omcmedical.com/medical-device-registration-in-spain/

Registration Process Determine the device classification Appoint Authorized Representative and Notified Body Class I device can be Self-Certified. QMS necessary but Notified …

The Spanish Agency of Medicines and Medical Devices …

https://www.aemps.gob.es/informa-en/the-spanish-agency-of-medicines-and-medical-devices-aemps-recommends-using-voluntary-harmonisation-procedure-before-the-official-submission-of-a-multi-state-ct-application/?lang=en

It has been more than two years since the launch of the Voluntary Harmonisation Procedure (VHP) in the European Union for the evaluation of multistate clinical trials. The process …

Spain Class I Medical Device Registration - Elsmar Cove …

https://elsmar.com/elsmarqualityforum/threads/spain-class-i-medical-device-registration.64303/

For class I devices you only need to register them in Spain if you are a Manufacturer or an European Representative located in Spain The registration …

Pharmaceutical & medical device advertising regulation …

https://cms.law/en/int/expert-guides/cms-expert-guide-to-advertising-of-medicines-and-medical-devices/spain

Under Spanish laws and regulations on medicines and medical devices, in order to guarantee the independence of the decisions relating to the prescription, dispensing, and …