This is what i meant (2)... you issue a DoC based on the ISO standard I mentioned, and your
Also, look what I found in the FedEx site:
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Standards
Portugal has established specific certification for certain products. This "homologation" involves cumbersome product testing by approved laboratories. However, a product that meets the standards and certification requirements of any other EU country can be imported and sold in Portugal without further testing. Portuguese homologation requirements remain in force for computer keyboards and screens, dot matrix printers, teleprinters, medical equipment, electric typewriters, telecommunications equipment, motor vehicles, bicycles, pleasure boats, gas connectors, etc. Portugal uses NP EN ISO 9000 Standards, which are equivalent to ISO 9000 standards. Exporters must demonstrate through a certifying entity that the products offered meet equivalent quality standards. On July 2, 1983 the legal framework for the "Portuguese Quality System" was established to monitor quality methods in Portugal. The "Portuguese Quality System" is organized in three areas: metrology, normalization, and qualification. The IPQ (Portuguese Institute for Quality) certifies standards in Portugal and is one of the entities responsible for the "Portuguese Quality System".
Several EU Directives are imposed on the electrical and electronic appliances, which govern standards on electromagnetic compatibility (EMC), low voltage (safety of electrical equipment); energy labeling of household lamps; and gas appliances, etc.
The Electromagnetic Compatibility (EMC) Directive requires that all electrical and electronic products to be sold in the EU market must not emit electromagnetic disturbance exceeding certain maximum levels, and must be of adequate levels of immunity to such disturbance.
The EU new Directive (98/101/EC) limits the content of mercury in batteries and accumulators imported into the European market from 1 January 2000. Regulated batteries and accumulators cannot contain more than 0.0005% by weight of mercury. The limitation of cadmium and lead remains the same as 91/157/EEC.
Imports of telecommunication products must be approved by British Approval Broad of Telecommunications (BABT) in UK and Federal Approvals Office for Telecommunications(Bundesamt fur Zulassungen in der Telekommunikation, BZT) in Germany.
Criteria for Eco-label for personal computer are: energy savings on monitors and control units; accompany with a commercial guarantee from the manufacturer that the computer system and the monitor will function for a period of three years and a year after the date of delivery to the customer respectively; composition of certain components of the computer where 90% of plastic and metal materials in the housing shall be recyclable; and the unit come complete with user instructions and an environment declaration of its ecological attributes.
Products to be sold to EU must carry a CE mark to show the product conform to the stipulated requirements in all directives. The CE mark shall affix onto the product by its manufacturer or importer, as a self-declaration. For some products, supplementary certification marks issued by a notified body as certification of conformity are required.
EU labeling regulations and standards need to be carefully monitored. Imports, which fail to meet marking and labeling requirement, will be refused for entry. Products bearing the CE mark are guaranteed free circulation within the EU market.
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The whole issue is to show conformity with the harmonized (or other European countries') standards ("homologation"). It is not clear whether an already certified product has to be checked ("by a competent body"), although it is CE marked.
Where are you exporting from ? I bet your customer will get an answer if he asks a customs' agent in Portugal. Otherwise, you may also ask the Portuguese commercial attachE of your local consular representation.
(I have a personal objection to the homologation, because conformity of a medical device with the harmonized standards is one of the ways to show conformity with the essential requirements of 93/42. If your company proves the conformity with the essential requirements in another manner, then they cannot demand conformity with the harm stands. If they insist on the harm standards then they will be violating articles 28-29-30 of the Treaty of the European Union. Therefore, I believe it is a matter of issuing a DoC -possibly the manufacturer/your customer, declaring conformity with 93/42.)
