Spain Medical Device Regulations

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Spain - Medical Equipment & Devices - International …

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

Spain still had not fully recovered from the severe impact of the 2007-2013 economic crisis at the onset of COVID-19 in 2020. According to the country’s healthcare technology federation, FENIN, Spain has a major problem with obsolete equipment. ... A revised EU Medical Device Regulation (EU) 2017/745, (MDR) came in… See more

Medical Device registration in Spain - Thema Med

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

Medical Device Registration in Spain. ... Like all the Countries of the European Union, Spain will also adopt the New Regulation (EU) 2017/745 on Medical Devices. It is …

Spain Medical Device Registration - AEMPS Approval …

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

The notification process, for medical and IVD devices, takes 2 – 3 months after submission of documents until receiving a …

Spain: New Medical Device Regulation In Spain Opened …

https://www.mondaq.com/healthcare/902354/new-medical-device-regulation-in-spain-opened-for-public-consultation

The prior public consultation is the initial stage of development of the Spanish Ministry of Health’s regulation of medical devices. This process allows stakeholders to provide …

Medical Device Registration in Spain - omcmedical.com

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

Medical Device Regulation. EU MDR 2017/745. Official Language . Spanish. Classification. Class I, IIa, IIb and III. Registration Process. Determine the device classification; Appoint Authorized Representative …

Agencia Española de Medicamentos y Productos Sanitarios

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

Productos sanitarios. 16/02/2023. La AEMPS publica una nota de aviso dirigida a organismos notificados y a fabricantes de espráis nasales con acción …

Things You Should Know When Registering Your …

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

Spain, just like all the other members of the European Union, uses a risk-based classification system and categorizes medical devices into four classes, I, IIa, IIb, and III. The two most significant legislations …

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

PDF version Date of publication: July 16th, 2012 Category: AEMPS, HUMAN MEDICINAL PRODUCTS, CLINICAL RESEARCHReference: MUH, 12_vi/2012 Versión en español …

Pharmaceutical & medical device advertising regulation …

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

Pharmaceutical advertising regulation and medical device advertising in Spain. 1. Which laws are applicable regarding advertising of medicines and medical devices? General …

Clinical Trial Regulatory Affairs in Spain - Sofpromed

https://www.sofpromed.com/clinical-trial-regulatory-affairs-in-spain

He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across …

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