THE IMPORT OF MASKS in france

Protective masks are classified into several categories according to their use. Subject to regulations which vary according to their category. Masks must comply with the regulatory standards applicable to their use and to the claims defined by the manufacturer and importer, like any product placed on the European Union market.

Bansard International document on medical device import from France : download here

Two types of masks. Different standards.

It is essential to clearly identify the type of mask to determine the documents required by Customs. 

PPE type masks (Personal Protective Equipment)
Also called "duck masks", called FFP1, FFP2, FFP3 according to their filtration potential, these filtering respiratory protection masks protect against exposure to respiratory viruses and bacteria. They are used as a priority by healthcare personnel, providing the best protection against fatal dangers and other infections that can cause irreversible damage, as in the case of coronavirus / Covid-19.
These masks are under the NF EN 149 + A1* standard and category III personal protective equipment or PPE, the standards of which are the most rigorous. This category III also includes gloves, visors, protective clothing, etc.
Since March 26, other equivalents of foreign standards have been accepted (NF- "norme Française"/french standard)

MD type surgical masks
Also called anti-splash masks, they limit the transmission of infectious agents, they protect others from the wearer. Surgical masks are medical devices (MD) covered by the EN 14683 standard*. We distinguish sterile masks (class IIB), individually wrapped, and non-sterile (class I), with various filtration levels.
Since March 26, other equivalents of foreign standards have been accepted 

Required documentation .

In the case of masks, the requirements are reinforced according to the category to which each type of mask belongs: a declaration of conformity or a certificate of engagement made by the importer. Mainly, a certificate of conformity will be requested, validated by a notified body (EU) in the case of CE marked products, or by an organization accredited by the issuing state and accompanied by a request for an EU certificate, in the case of '' an equivalence of foreign standards and a test report. The equivalence of foreign standards may involve new procedures, so let's mainly retain the documents prerequisite in priority for these two types of masks:

PPE type masks
- Declaration of conformity drawn up by the manufacturer, his authorized representative or the importer, in French or in English, including the name and address of the manufacturer, the product reference, the reference to the reference or to the text underlying the CE standard or the equivalent foreign standard.
- Certificate of conformity validated by a notified organization for the product
- Test report

MD type masks
- Affixing of CE marking
- Presentation on request from the service: CE declarations of conformity and technical file or the EC type examination certificate for products concerned by medical device regulations.
- Test report

Equivalence of standards on imported masks:
In order to facilitate the import of masks, the Customs Department issued a note to operators on March 26 stating that "until the end of the health crisis, masks can be imported without CE marking provided that the importer establishes that '' they comply with European standards or certain foreign standards recognized as equivalent, at the time of their importation. Precisely :
FFP2 type masks conforming to American standards US N95 and Chinese standards KN 95 and GB / T 32610-2016 (class A) are notably admitted, exceptionally, on the grounds of their equivalence with standard EN149.

Importers are invited to present during import customs clearance all supporting documents attesting to the compliance of the products with these standards.

Import duty rates.

Masks are subject in France to import customs duties, again depending on their category of product type.

- PPE type masks (FFP1,2,3 or foreign equivalent) subject to 6.3% duties.
- MD type masks (surgical) are not subject to any customs duties.

 
EVERY IMPORT OF SANITARY MATERIAL, BUT MASKS.

As masks, the other products for medical use, including plastic visors, gowns, protective glasses, gloves and digital or infrared thermometers are also classified in the PPE type categories (Protective Equipment Individual) or DM (Medical Device). These belong to one or other of the categories according to their characteristics. Like masks, these products must comply with the regulatory standards applicable to their use and to the claims defined by the manufacturer and importer.

Two categories. Different regulations.

It is essential to properly identify the category of the type of PPE or DM product to determine the documents required by Customs.

Product type category PPE (Personal Protective Equipment)
This product type category includes:
- PPE type masks 
- Plastic visors
- Protective glasses with / non-plastic lenses
- Plastic gloves
- Disposable powder-free chemical gloves (not reusable)

Category type product MD (Medical device)
This product type category includes:
- MD type masks (surgical)
- Surgical gowns
- Surgical gloves (not reusable)
- Digital or infrared thermometers

PPE type product regulation: Regulation (EU) n ° 2016/425 of March 9, 2016 relating to protective equipment

Regulation of MD type products: Council Directive 93/42 / EEC of June 14, 1993

Required documentation.

In the case of masks, the requirements are reinforced according to the category to which each type of mask belongs: a declaration of conformity or a certificate of engagement made by the importer. Mainly, a certificate of conformity will be requested, validated by a notified body (EU) in the case of CE marked products, or by an organization accredited by the issuing state and accompanied by a request for an EU certificate, in the case of '' an equivalence of foreign standards and a test report. The equivalence of foreign standards may involve new procedures, so let's mainly retain the documents prerequisite in priority for these two types of masks:

Documents for PPE type products
- Declaration of conformity drawn up by the manufacturer, his authorized representative or the importer, in French or in English, including the name and address of the manufacturer, the product reference, the reference to the reference or to the text underlying the CE standard or the equivalent foreign standard.
- Certificate of conformity validated by a notified organization for the product
- Test report

Documents for MD type products
- Affixing of CE marking
- Presentation on request from the service: CE declarations of conformity and technical file or the EC type examination certificate for products concerned by medical device regulations.
- Test report

Equivalence of standards on MD type sanitary products:
Declaration of conformity to CE standards signed download example

Equivalence of standards on MD type sanitary products:
No equivalences

Import duty rates.

Medical equipment is subject to import customs duties in France, this time the rate varies depending on the products:

- Plastic visors subject to duties of 6.5%.
- Surgical gowns subject to duties of 12%.
- Protective glasses with / non-plastic lenses subject to duties of 2.9%.
- Plastic gloves subject to duties of 6.5%.
- Surgical gloves (not reusable) subject to duties of 2%.
- Disposable powder-free chemical gloves (not reusable) subject to duties of 2.7%.
- Digital or infrared thermometers are not subject to any customs duties.

Please find here the Bansard international's document(.pdf), summarizing precisely the import standards for medical equipment: download here

Given the current context, these regulations are subject to change, and updates including new standards for each product may be included. We will not fail to post our article as well.

FOR MORE INFORMATION, PLEASE CONTACT : CONTACT@BCSCUSTOMS.COM

Source: Douane.gouv.fr