Portugal Medical Devices

Portugal has approximately 200 companies distributing medical devices. Over 80% of medical devices expenditures in Portugal are made by the public sector, while 20% of sales are made to the private sector. Prices are of primary importance in all purchasing decisions, both by the public and private sectors.

The best sales potential in the Portuguese market are surgery equipment, patient monitoring systems, mini invasive surgery (MIS) equipment, noninvasive medial apparatus, video endoscopes, X-Ray equipment, digital image processing, magnetic resonance imaging (MRI) equipment, picture archiving systems.

Major suppliers to the medical devices in Portugal are: U. S. Germany, France and Japan. Increased opportunities for U.S. manufacturers are expected in coming years, as the market is very receptive to U.S. products, mainly of high quality and price competitive, as technically sophisticated medical devices are the ones with the best market potential in Portugal. The major U.S. companies with offices and distribution in Portugal include 3M, Abbott, Alcon, Applied Medical, Baxter, BD, Boston Scientific, Cardinal Health, Edwards, Johnson & Johnson, Medline, Medtronic, Merit Medical, Smiths Medical and Stryker. These are all members of APORMED -Portuguese Association of the Medical Devices Companies). As a member of the European Union, Portugal follows directives from the European Commission (EC) and the same medical device classification as all other EU member states.

Medical devices are classified according to risk into Classes I, IIa, IIb and III. Before marketing your medical devices in Portugal, you must make sure that your product has been CE-marked, which is a sign of conformity with current EU regulations, allowing for the device to be sold freely in the European market. In addition to the CE marking, all classes of medical devices coming to the Portuguese market must go through a device registration process, even though the requirements for registration of Class I medical devices are different than the ones for registration of Class IIa, IIb, III and implantable active medical devices.

The Portuguese Regulatory Authority (RA) is INFARMED-National Authority of Medicines and Health Products), an agency within the Portuguese Ministry of Health, which evaluates, authorizes, regulates and supervises the market, regardless of the origin of the devices, guaranteeing the protection of public health. Distributors are also required to notify the Competent Authorities of all medical devices they are placing on the Portuguese market. The manufacturer relinquishes an essential part of his control over his product in Portugal by registering his devices through his distributor. A medical device manufacturer with the head office outside the European Economic Area (EEA), must be represented by an authorized Representative (AR) established in the Community.

The manufacturer may only be represented by a single AR for each type of device. To enter the Portuguese market of medical devices, U.S. manufacturers are required to appoint an AR, to assist with all the details regarding the registration process and to complete the requirements under the Portuguese regulation. After the documentation review, U.S. manufacturers can proceed with the registration with INFARMED. 

There are no significant barriers on U.S. medical devices or products. However, it was created and implemented an additional tax to the suppliers of medical devices to the National Health Service (NHS). Subject to this tax are the suppliers, manufacturers, their representatives or intermediaries, wholesale distributors or just traders, charging the NHS entities for the provision of in vitro diagnostic, medical.

For more information contact office.lisbon@trade.gov.