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Below is a brief summary of the said legislation.

Communiqué on Import Inspection of Medical Appliances (Product Safety and Inspection: 2017/16)

Official Journal Date : 30.12.2016
Official Journal Number : 29934

Medical devices (laid down in Annex 1 to this Communiqué) to be imported shall comply with the provisions of the Regulation on Medical Devices, the Regulation on Active Implantable Medical Devices, the Regulation on In Vitro Diagnostic Medical Devices which were issued by the Ministry of Health and comply with the safety requirements.

Following subjects are covered in the Communiqué:

  • Risk analysis and Risk Based Control System in Foreign Trade (TAREKS)
  • List of Medical Devices which are subject to Inspection on import, based on the Regulation on Medical Devices, the Regulation on Active Implantable Medical Devices, and the Regulation on In Vitro Diagnostic Medical Devices
  • Construction Products that are/are not required to bear CE Marking
  • Exemptions and Exceptions
  • EC Declaration of Conformity and EC Certificate of Conformity
  • LETTER OF COMMITMENT TO THE MINISTRY OF ECONOMY
  • Product Inspectorates Group Chairmanships and Directorate of Customs and Enforcement within their area of responsibility

List of Medical Devices which are subject to Inspection on import, based on the Regulation on Medical Devices, the Regulation on Active Implantable Medical Devices, and the Regulation on In Vitro Diagnostic Medical Devices are laid down in Annex 1 to the Communiqué. There are currently 46 different products (i.e. HS codes and explanation of these products are laid down in the aforesaid Annex) and they fall in the scope of the following headings in Turkish Customs Tariff Schedule :

  • 30.02
  • 30.06
  • 33.07
  • 38.08
  • 38.21
  • 38.22
  • 40.14
  • 84.21
  • 90.01
  • 90.18
  • 90.19
  • 90.21
  • 90.22
  • 90.27
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