COVID-19

COVID-19

HOW CAN WE HELP YOU IN YOUR IMPORTS OF COVID19 SANITARY MATERIAL?

MDI Advisers puts at your disposal all our experience, equipment and resources for the importation of medical equipment so that we can defeat the coronavirus.

 

CAN I BUY AND IMPORT MASKS, RESPIRATORS AND OTHER SANITARY MATERIAL NECESSARY TO protect against CORONAVIRUS?

The import of masks and sanitary material is authorized, but a series of procedures must be followed to do it correctly, therefore, whether you are a sanitary company or any other type of business that may have needs for sanitary products in their commitment to the health and safety of your staff, you can import the masks and protective equipment you need. MDI is your trusted team.

 

WILL THE GOVERNMENT SEIZE THE IMPORTED SANITARY MATERIAL?

To date, there are no plans for seizing, confiscating or requisitioning imported products by the Ministry of Health.
Faced with the doubts generated after the Order SND / 233/2020, of March 15, which was to inform this of all the stocks of medical devices and PPE, the Government has issued an explanatory note merely for information and stock control.

You can find out about the adopted measures published in the BOE.

 

WHAT DOCUMENTATION IS NEEDED TO IMPORT MASKS, TESTS, GLOVES AND OTHER SANITARY PRODUCTS FOR THE FIGHT AGAINST CORONAVIRUSES?

The requirements to import these materials are the usual ones, therefore, it is necessary to have a license to import medical devices under the aforementioned conditions. To highlight the provision of authorized sanitary warehouses (own or subcontracted) with a responsible Sanitary Technician.
You also need to submit the following documentation for review:

 

• Gloves and masks:

Declaration of conformity.
Labelling of the boxes *.

• Test and contactless thermometers:

Declaration of conformity.
Labelling of the boxes *.
Instructions for use*.

• For gel import:

An analysis of its composition should be carried out.

* Labels and instructions must, as a rule, be in Spanish or multilingual. Otherwise, given the urgency for the supply of these products, we would contact AEMPS in advance to authorize it if they consider it necessary.

 

WHAT SANITARY MATERIAL CAN I IMPORT FOR THE FIGHT AGAINST COVID-19?

– Type II and IIR surgical masks.
– FFP2 protection mask.
– FFP3 protection mask.
– COVID-19 diagnostic PCR kits and their consumables.
– Rapid diagnostic kits (antigen detection).
– Swabs.
– Safety glasses.
– Nitrile gloves, with and without powder.
– Disposable and waterproof gowns.
– Hydro alcoholic solution (biocide and cosmetic) and its raw materials.
– Invasive mechanical ventilation (VMI) devices.
– VMI equipment consumables or consumables.
– Sanitary alcohols.
– Chlorhexidine.

 

What masks can I import?

To facilitate the entry of medical supplies into Spanish territory, the Government has lowered the requirements for the importation of face masks on a temporary basis.
In addition to the masks with regulatory CE marking, they may import:

– PPE type masks without CE marking prior authorization from Health and for supply to health personnel.

– Protection masks without CE marking, after analysis by a Health authority or an autonomous community while
They carry out the necessary procedures to put the CE marking.

– Masks that have CE marking with a different technical specification than the harmonized standards.

 

What other sanitary equipment can I import?

In addition to masks, there are other products for the prevention and treatment of the COVID-19 virus such as gloves, protective glasses, respirators, hydro alcoholic gels, thermometers, diagnostic tests, etc.

To facilitate the correct classification of merchandise, the Tax Agency has distributed a table with the tariff headings of the most demanded medical devices.

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