Importing medical devices

You can count on our team of professionals, who are experts in processing and obtaining import licences for medical devices and products

Medical instruments, medical and surgical equipment, medicines, tattooing materials, natural medicines and cosmetics, glasses, hearing instruments, lenses, wheelchairs and others.

Obtain your import licence. We offer approved medical warehouses and the services of an expert product manager with in-depth knowledge of medical logistics and health legislation.

Contact us!

+34 961 340 787

LOGISTICS AND THE TRANSPORTATION OF MEDICAL DEVICES AND PRODUCTS

An import health licence issued by the Spanish Agency of Medicines and Medical Devices (AEMPS) is required in order to import medical devices and products.

At TIBA we help companies in the pharmaceutical and medical field import products such as medical instruments, medical and surgical equipment, medicines, tattooing materials, natural medicines and cosmetics, etc. into Spain.

We have a specialised healthcare logistics team with professionals, who are experts in processing and obtaining import licences for medical devices and products, as well as offering approved medical warehouses and the services of an expert product manager with in-depth knowledge of medical logistics and health legislation.

TIBA is the only Spanish freight forwarder and customs agent that has a health authorisation, issued in 2011, for the temporary storage of medicines and medical devices in a customs-linked facility.

Services specialized in importing medical devices

Before importing
- We check all of the source documentation to ensure it complies with European Union requirements.
- We provide consulting services for CE marking.
Importing
- We can help you with the import licence requirements for medical devices.
International transport
- We always offer the most appropriate shipping, air freight or haulage options depending on the urgency and the particular characteristics of the operation. Your products will arrive on time at their destination complying with all of the relevant legal and logistics requirements.
Customs clearance
- We have specialists in customs clearance for this type of product. We make sure your goods reach their destination with no last-minute hitches.
Before commercialisation
- We can offer you advice. If we are responsible for the products, we register the marketing authorisations for each product as well as handling any related notifications.

WHAT IS A MEDICAL DEVICE?

According to Law 10/2013, a medical device is defined as:

“Any instrument, apparatus, equipment, material, computer software or other article, used alone or in combination, including computer software intended by the manufacturer to be used for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used on human beings for the purpose of:

1. Diagnosis, prevention, monitoring, treatment or alleviation of illness.

2. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap.

3. . Investigation, replacement or modification of the anatomy or of a physiological process.

4. Control of conception.

And which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted by such means”.

MEDICAL DEVICE TARIFF HEADINGS

A table of medical devices and their corresponding tariff headings are shown below so that, depending on the origin of your goods, you can find out from the Spanish Tax Agency what import duty you will have to pay, using your electronic signature certificate.

MEDICAL DEVICES
PRODUCT	TARIFF HEADING	CLASS
Mobility devices	8713	Class I
Diagnostic devices	9027	Class II
Massage devices	8543	Class I
Medical apparatus	9018	Class II
Hearing instruments	9021	Class II
Gowns	6210	Class I
First-aid kits	3006	Class I
Glasses	9003	Class I
Dressings	5208	Class I (not sterile)
Gloves and gowns	3926	Class I o II
Instruments	9018, 9019	Class II o III
Lenses	9001	Class II
Dental equipment	3407, 3306	Class II o III
Stockings	6115	Class I
Medical or dental furniture	9402	Class I o II
Glasses frames	9004	Class I
Crutches and walking sticks	9021	Class I
Orthopaedics	9021	Class I o II
Incontinence pads	9619	Class I
Insoles	6406	Class I
Condoms	4014	Class II or III (with spermicide)
Wheelchairs	8713	Class I
Pregnancy tests	3822	Class II
Bandages	3005	Class I (not sterile)
Bandages	6807, 5208	Class I (not sterile)

THE ADVANTAGES OF OUR EXPERTISE AND IMPORT HEALTH LICENSING

Traceability of all products from their country of origin to their final destination, particularly from China, ensuring quality control of manufacturing and supplier approval, etc.
Processing all of the necessary import licences for medical devices and products.
Managing the imports as well as the distribution of medical devices and cosmetics within the European Union.
Coordinating the transportation of all medical devices and cosmetics according to the requirements of each type of product, via air freight, shipping, haulage, or courier services.
Processing customs clearance as well as initial health, pharmaceutical and veterinary inspections, etc.

WE ADVISE OUR CUSTOMERS

We advise our customers on medical device and cosmetics legislation prior to importation. Through our medical warehouses, we are sometimes able to solve issues of non-compliance with import regulations for medical devices in terms of CE markings, declarations of conformity, European Economic Area (EEA) regulations, labelling regulations, etc.

We help our customers with the procedures required by the Spanish Agency of Medicines and Medical Devices (AEMPS) for them to commercialise or get their medical devices to market.

We also process other types of licences such as those required for distribution within the different Spanish autonomous regions and those required for setting up and operating clinics.

TIBA and the Romeu Group offer you their services in Spain, Portugal and Mexico in medical logistics, medical warehousing, international transport and customs clearance with different industry solutions for importing medical devices and products that are subject to the Spanish Agency of Medicines and Medical Devices (AEMPS) regulations.