Portugal Import Regulations for Pre-Owned (Used and Refurbished) Medical Devices - Customs Forum

**admin** · 07-23-2011, 18:14 PM

No Restrictions, but CE Mark is Required
Portugal is governed by the EU harmonized legislation/directive which covers the importation of new and used medical devices to Europe. The importation of new and used medical equipment for use in Portuguese public hospitals and/or private clinics and medical centers must be certified by the appropriate Portuguese authorities. These devices, when imported from third countries to be sold in Portugal, have to undergo a complicated certification process by a credited entity in the EU. If devices pass this certification, they are marked 'CE' and may move freely and be sold in all countries in the EU.
This EU directive primarily focuses on certain minimum requirements for the medical devices entering Portugal. All credited organizations are attributed a 4 digit identifying code by the European Commission. In Portugal, the official entity that is credited to attribute the CE mark is:
LEMES-Laboratorio de Ensaios e Metrologia da Saude
Av. Padre Cruz
1600-560 Lisboa
Tel: (351-21) 757-5853 / 757-3557
Fax: (351-21) 757-3671
Contact: Eng. Faria Gomes, President
Import duties are equally applied to new and used medical equipment, these vary between 0 and 7.5 percent when entering from third countries and 0 percent when of EU origin. Once cleared by customs in any one EU country, goods may move free of duty within the EU. A Value-Added Tax (19 percent) is applied ad valorem to all goods entering Portugal.

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