Free Sale Certificate or Certificate of Free Sale, FSC or CFS. Institutions in EEA member States and other individual countries (some even local non-governmental manufacturers' associations) in order to promote the export of domestic (local) manufactured products to other third countries outside the EEA, issue a free sale certificate for local manufacturers, which is to prove that their products meet the requirements of the relevant EC directive. It can be sold freely within the country (local).
After the medical device products are affixed with the CE mark and registered in the EU as required by the relevant directives or regulations, the manufacturer does not need a free sales certificate to export to the EU. However, in order to enter the non-EU market, the manufacturer must provide the export destination country with a free sale certificate to prove that the product bearing the CE mark has been legally placed on the EU market. The only authority authorised by an EU directive or regulation and Competent to issue a certificate should be the Competent Authorities for medical devices (CA) of the EEA Member States. If the manufacturer is not located in Europe, only an EU authorised representative can apply for and obtain a free sale certificate on behalf of the manufacturer.
Why register with WEEE?
Waste electrical and electronic equipment is one of the fastest growing waste in the EU, at around 9 million tonnes in 2005, which the European Commission expects to increase to more than 12 million tonnes by 2020. By 2025, the world will generate 60 million tons of electrical and electronic waste per year. Electronic waste consists of a variety of materials and components, including rare and expensive raw materials and harmful components. In response to this problem, the WEEE introduced by the EU creates a legal framework for the collection of used electrical and electronic equipment from consumers, the reduction of the proportion of these equipment in domestic waste and the professional collection of raw materials and recycling.
According to the German Electrical and Electronic Equipment Act (ElektroG) :
Before the manufacturer (customer) places an electrical or electronic device on the market, its authorized representative (statelab) is obliged to register the type and brand of the device with the competent authority.
The manufacturer (customer) shall not place electrical or electronic equipment on the market without authorizing its registered representative or without properly registering it.
The simple summary is: before the registration of WEEE, it is illegal to sell all kinds of electronic and electrical equipment in any form in Germany.