FIND OUT ABOUT COVID-19 MEASURES FOR IMPORTING FACEMASKS, VENTILATORS AND OTHER MEDICAL DEVICES
Some measures for importing medical equipment and supplies have changed due to the current health situation. Read on to find out more.
CAN I BUY AND IMPORT FACEMASKS, VENTILATORS AND OTHER MEDICAL SUPPLIES NEEDED TO COMBAT THE CORONAVIRUS?
Importing facemasks and medical supplies is allowed, but you do have to follow a number of procedures to do it properly. So, whether you are a healthcare company or any other type of business which may need medical devices as part of its commitment to the health of its employees, you can import the facemasks and protective equipment you need.
The Ministry of Health has not banned imports into Spain of the products described in the order. Once you have complied with the duty to provide information specified in Order SND/233/2020, you can continue to supply your customers.
WILL THE GOVERNMENT SEIZE IMPORTED MEDICAL SUPPLIES?
Find out about the measures published in the BOE (Official State Gazette).
To date, the Spanish Ministry of Health has not planned any seizure, confiscation or requisition of imported products.
In response to the uncertainty surrounding Order SND/233/2020, de 15 de marzo, dated 15 March, which required the Ministry of Health to be informed of all stocks of medical devices and PPE, the Government has issued a guidance note exlpaining
that the Order is merely for information and stock control purposes and there is no intention to seize, confiscate or requisition the devices.
The media have run numerous stories on this topic including the seizure of facemask material from a company in Jaen. In fact, the supplies were not seized but rather the investigation was due to CE marking issues.
The company’s CEO put out the following statement to the media:
“The purpose of this statement is simply to clarify our current situation and to deny and halt the misinformation which is being reported by some media outlets. Our production has been seized but not confiscated, we have been inspected on public health grounds and we have responded to and cooperated without hesitation with the law enforcement agencies to provide our entire stock of facemasks and make our production line available to them.”
You can learn more about this incident from other media outlets which have fact-checked the information: Maldito bulo, Newtral, Eldiario.es
WHAT DOCUMENTATION DO YOU NEED TO IMPORT MASKS, TESTS, GLOVES AND OTHER MEDICAL DEVICES?
Imports of all these medical supplies have to meet the usual requirements which means you will need to have a medical device import licence.
This licence is conditional on the availability of authorised medical device warehouses with an expert health product manager.
The import licence authorises its holder to import particular medical devices via certain facilities or medical device warehouses under the supervision of an expert health product manager for a given period of time.
The following documents also have to be submitted for review:
- Gloves and masks:
- Declaration of conformity
- Labelling of the boxes*
- Tests and contactless thermometers:
- Declaration of conformity
- Labelling of the boxes*
- Instructions for use*
- For hand sanitiser imports:
- Their composition must be analysed.
*As a rule, labelling and instructions must be in Spanish. Otherwise, and given the urgency of supplying these products, the Spanish Agency of Medicines and Medical Devices (AEMPS) must be contacted beforehand for authorisation if this is deemed necessary.
WHAT MEDICAL SUPPLIES CAN I IMPORT TO COMBAT COVID-19?
Which facemasks can I import?
To make it easier to bring medical supplies into Spain, the the Government has temporarily relaxed the requirements for importing facemasks.
In addition to masks with the regulatory CE marking, the following may also be imported:
- PPE masks without CE marking with prior authorisation from the Ministry of Health and for supplying healthcare personnel.
- Protective masks without CE marking, subject to analysis by a Health or regional authority while the procedures are being carried out to affix the CE marking.
- Facemasks with CE marking with a technical specification other than the harmonised standards.
What other medical equipment can I import?
In addition to facemasks, there are other products for preventing and treating the Covid-19 virus including gloves, eyewear protection, ventilators, hand sanitiser, thermometers, and diagnostic tests.
To make it easier to classify goods correctly, the Tax Agency has drawn up a table with the tariff headings of the most sought-after medical devices.
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