The import of frames for prescription glasses is regulated in Spain by the Spanish Agency of Medicines and Medical Devices (AEMPS), as they are considered medical devices and, therefore, must meet specific safety requirements as well as certification of compliance with the standards set out in Directive 93/42/EEC.The Royal Decree 1591/2009, following the community directive, establishes four categories of medical devices according to their level of interaction with the human body. According to this classification, the import of frames for prescription glasses falls under Class I, as they are considered accessories to medical devices (in this case, accessories to corrective lenses). Sunglasses are not considered medical devices, although they must be approved.Frames for prescription glasses are considered Class I medical devices, thus benefiting from a reduced VAT of 10%. Their importation requires holding a health license and the manufacturer providing a declaration of conformity ensuring compliance with European regulations.The import of frames for prescription glasses, mostly originating from China and Hong Kong, both OEM (white label) and European patented, implies that since 2011, when they were classified as medical devices, importing companies must hold a specific import license for this type of merchandise.This regulatory change also affects the VAT applied to such products in customs clearance. While until 2011, the import of frames for prescription glasses was subject to a VAT rate of 21%, since their inclusion in Class I medical devices, the tax has been reduced to 10%.This reclassification of frames for prescription glasses affects those made of plastic as well as those made of other materials. In 2013, the list of tariff headings subject to control by the AEMPS was updated, now including tariff headings 90031100 and 90031900 for the import of frames for prescription glasses, making this merchandise subject to pharmaceutical inspection at the border.
Requirements for the import of frames for prescription glasses
The requirements for the import of frames for prescription glasses were updated in 2013 when they became classified as medical devices, thus the required documentation was also modified. Currently, these requirements are as follows:
- The importer must hold a health license
- An import or transfer license is required
- A 10% VAT will be applied on the commercial invoice
- A bill of lading BL or AWB must be provided, depending on the mode of transportation
- The manufacturer must provide a declaration of conformity ensuring compliance with current European regulations
This last point is especially important, as the declaration of conformity does not require verification by any external body other than the manufacturer. However, if the medical device does not meet the standards outlined in Directive 93/42/EEC, the importer will be the primary affected party, as the merchandise will be detained.To avoid such incidents, which can result in substantial losses, at Bull Importer we conduct thorough location and verification of suppliers to ensure to our clients that frames for prescription glasses meet all necessary guarantees.
