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General Assessment Of The Regime Regarding Technical Regulations And Standardization For Foreign Trade

General Assessment Of The Regime Regarding Technical Regulations And Standardization For Foreign Trade

The Undersecretariat of Foreign Trade prepared the "Ministerial Decree on the Regime of Technical Regulations and Standardization for Foreign Trade" and its supplementary legislation with the aim of providing transparency in the implementations, assembling all the dispersed regulations regarding standardization policies in Turkey and establishing a legal base for the harmonization of Turkish legislation with the Community’s.

The "Decree on the Regime of Technical Regulations and Standardization for Foreign Trade" is in conformity with the requirements laid down in the Agreement on Technical Barriers to Trade of the World Trade Organization. It prohibits discrimination among trading partners and it aims to ensure that import products comply with the requirements of protection of human health and safety, animal or plant life or health, or the environment.

The Regime mainly consists of the Ministerial Decree (i.e. Decree No: 2005/9454, for Technical Regulations and Standardization for Foreign Trade, published in the Official Journal on October 13, 2005) , a Regulation and related Communiqués. The Regulation and the Communiqués are amended every year, except the Communiqué on the Imports of CE Marked Products (published in the Turkish Official Gazette dated 14.Feb.2004 No. 25373) , for the year 2008 they have been promulgated in the Turkish Official Gazette dated 31.Dec.2007 No. 26743.

Turkey has finalized the harmonization of EU’s New Approach Directives concerning medical devices, active implantable medical devices, machinery, low voltage equipment and electromagnetic compatibility and put into force the relevant technical regulations in the domestic market. Import controls of these products are regulated by the Communiqué on the Imports of CE Marked Products, which was promulgated in the Turkish Official Gazette dated 14.2.2004 and numbered 25373.

According to this Communiqué, toys, medical devices and active implantable medical devices are subject to inspection by the TSE, which was authorized by the Ministry of Health to carry out these inspections, at the import stage. Products falling under the directives on machinery, low voltage and electromagnetic compatibility are also inspected by the TSE on behalf of the Ministry of Industry and Trade. The inspections are carried out in respect of essential requirements, which are laid down in the technical regulations regarding these products.

A letter of conformity shall be issued by the TSE in case that the “Declaration of Conformity” is submitted to the TSE before the import stage. However, the TSE may still request the technical file and test the products, if required, with the aim of checking out whether the certificates and/or marks (CE mark) are issued in accordance with the Regulations of Toys, Medical Devices, Active Implantable Medical Devices, Machinery, Low Voltage and Electromagnetic Compatibility.

Besides, products, which are certified according to directives of the European Communities mentioned above, and which are freely circulated in the European Union, are not subject to any inspection procedure at the import stage.

On the other hand, toys, medical devices, active implantable medical devices and products covered by the directives of low voltage equipment, electromagnetic compatibility and machinery which are certified according to directives of the European Communities and which are freely circulated in the European Union, are not subject to any inspection procedure at the import stage unless it is obvious that these products present serious risk and danger.