we are handling many imports of MASKS related to the COVID19 issue, becoming one of the most expert on this operativeness.
We have thence prepared a “list” of rules to be followed to avoid problems and troubles
| (A) | Medical Masks | (CHIRURGICAL MASKS) | |
| (a) | With CE CERTIFICATE: it can be custom cleared | ||
| (b) | Without CE CERTIFICATE: an application from the IMPORTER must be submitted to SANITARY authorities to obtain a SANITARY certificate | ||
| 1. | If SANITARY authority approves and the certificate is released, they can be custom cleared | ||
| 2. | If SANITARY authority doesn’t approve, the masks can be custom cleared as “generic items” (in this case, they must be marked clearly that are “generical items”, with special warnings about their status. And no CE marks must be shown anywhere – see also the point (C)) | ||
| (B) | DPI (FFP2 FFP3) | (KN 95) | |
| (a) | With CE CERTIFICATE: it can be custom cleared | ||
| (b) | Without CE CERTIFICATE: an application must be submitted from the IMPORTER to INAIL authorities | ||
| 1. | If INAIL approve, the masks can be custom cleared | ||
| 2. | If INAIL doesn’t approve, the masks can be custom cleared as “generic items” (in this case, the masks must be marked clearly that are “generical items”, with special warnings about their status. And no CE marks can be shown anywhere – see also the point (C)) | ||
| (C) | Generical Items | Not for protective use | |
| (a) | must not bear the marking CE | ||
| (b) | the packaging must expressly indicate that it is not a Medical Device (DM) or Personal Protective Equipment (PPE) | ||
| (c) | must be accompanied by a warning that clearly indicates that they do not guarantee in any way the respiratory protection of the wearer, which are not usable when the use of Medical Devices or Personal Protective Equipment is prescribed (for sanitary use or in the workplace) but only by way of | ||
| (d) | The Manufacturer MUST declare that Generic Devices do not cause damage and do not cause additional risks for users, according to the destination of the product. | ||
We really hope this can be helpfull for your neeedings. For any further information and/or clarification, do not hesitate to contact us
Paolo Federici
(this rules are updated May 20th 2020. Please contact us BEFORE moving any cargo to Italy to check that no problem will arise once cargo is arriving!)
