Spain Medical Device Regulation

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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 devices; AEMPS bulletins and reports on medical devices; Registration of implantable …

Spain - Medical Equipment & Devices - International …

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

Spain Medical Device Registration - AEMPS Approval …

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

Medical Device Regulations and Classification in Spain REGULATORY AUTHORITY: Devices are regulated by the Spanish …

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 …

Draft text of new Spanish regulation on medical devices …

https://www.engage.hoganlovells.com/knowledgeservices/news/draft-text-of-new-spanish-regulation-on-medical-devices-is-opened-for-contributions

In this respect, the new regulation aims to: (i) repeal the existing legal texts on medical devices (Royal Decree 1591/2009) and active implantable medical devices …

Spain: New project for royal decree regulating medical …

https://www.globalcompliancenews.com/2021/07/06/spain-new-project-for-royal-decree-regulating-medical-devices21062021/

The Spanish Ministry of Health is working on a project for a new royal decree regulating medical devices following the adoption of a new framework at the European level through Regulation (EU) 2017/45 …

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. …

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 and Notified …

Things You Should Know When Registering Your …

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

AEMPS can provide a medical device with a CE marking, which allows manufacturers to freely market their device within all countries belonging to European Union. Under current regulations, a CE marking …

Pharmaceutical & medical device advertising regulation …

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

In general terms, the failure to comply with the relevant rules applicable to the advertising of medicines and medical devices may entail administrative infringements punishable …

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