WHAT IS AN IMPORT LICENCE FOR MEDICAL DEVICES AND PRODUCTS?
In order to import medical devices and products from third countries an import licence issued by the Spanish Agency of Medicines and Medical Devices (AEMPS), under the Ministry of Health, is required.
The licence represents compliance with the current legislation on the importation of medical products.
The import licence for medical devices and products is usually valid for five years, after which time it must be renewed if necessary.
HOW IS AN IMPORT LICENCE FOR MEDICAL PRODUCTS AND DEVICES PROCESSED AND OBTAINED?
Obtaining an import licence is a laborious process. The requirements laid out below must be submitted to the Spanish Agency of Medicines and Medical Devices (AEMPS), which comes under the Ministry of Health.
The usual timeframe involved in processing and obtaining an import licence is between three and six months.
REQUIREMENTS FOR OBTAINING AN IMPORT LICENCE FOR MEDICAL DEVICES AND PRODUCTS
The process of obtaining an import licence for medical devices and products involves:
- Submitting a technical report to the AEMPS outlining how current legislation will be complied with in terms of facilities, processes and certifications, etc.
- Having either in-house or outsourced AEMPS approved warehousing. The warehouse size will depend on the company’s activity and the type of product involved. TIBA has AEMPS-approved medical warehousing with the most up-to-date security and monitoring systems.
- Having a qualified person who, among other duties, will be responsible for batch release and distribution. Without the qualified person’s authorisation, the company will not be able to sell the imported products.
Although the profile of the qualified person differs in the various autonomous regions of Spain, generally, high-level graduates or professionals who are licensed in the health professions, i.e., medicine, pharmacy, dentistry, veterinary medicine or opticians can perform the role of qualified person.
However, there are some restrictions in this respect. Doctors and dentists cannot perform the role of qualified person and be in clinical practice at the same time. In some autonomous regions, professionals with a connection to medical device and product manufacturing techniques such as chemists, industrial engineers and biologists can approve distribution but not importation.
IS IT POSSIBLE TO IMPORT WITHOUT AN IMPORT LICENCE FOR MEDICAL DEVICES AND PRODUCTS?
We offer you the opportunity to import medical devices and products whilst your import licence is being processed. This measure, authorised by the Spanish Agency of Medicines and Medical Devices (AEMPS), is only available to those companies for whom an import licence for those same products is being processed. The cost of using this licence is usually a small percentage of the value of the products being imported.
If you wish to import cosmetics, perfumes or personal care products you can do so by submitting a Declaration of Conformity.
If you do not have an import licence, you can rely on TIBA to process or advise you on how to obtain your import licence for medical devices and products.
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