AEMPS seeks return to normal for medical devices

As the coronavirus pandemic stabilises in Spain, the Agencia Espanola del Medicamento y Productos Sanitarios (AEMPS – Spanish Medicines Agency) has called for a return to normal procedures for medical devices to be used in the country.

Demand for certain products was extremely high at times during the first weeks of the COVID-19 outbreak in Spain, leading the AEMPS to allow ‘extraordinary import authorisations’. Now that demand has stabilised, the Agency intends to revert to its normal procedures.

AEMPS said:

“The health crisis caused by the SARS-CoV-2 has generated in the Spanish market a demand well above the usual for certain medical devices such as, for example, surgical masks, gloves, in vitro diagnostic tests, thermometers, etc.

“Many of these products have come through imports from third countries. The requirements for the importation of medical devices into Spain are established in Royal Decree 1591/2009, of October 16, which regulates medical devices.

“Those entities that intend to import medical devices must request the prior operating license, through the IPS telematic application at the AEMPS electronic headquarters. For this they have the INSTRUCTION PS 1/2019, where all the process and information necessary for the application are collected and can be found at the following link:

https://www.aemps.gob.es/productosSanitarios/docs/instrucciones-obtencion-licencias-instalaciones-PS.pdf?x57200

Read the full press release here for further information and useful notes on the normal procedures for importing medical devices to Spain.

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Published on 22. June 2020 in News, News Spain, Press Release