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Medical
Device Regulatory
Requirements for
Turkey
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Updated:
10/24/00.
Disclaimer: The information contained on this website is derived from public sources and is current to the best of our knowledge. For detailed and definitive information about a country's laws and policies, the government of the country concerned should be consulted.
Current System
The regulatory system in Turkey is in transition pending the adoption of the Turkish Medical Devices Directive. Turkey is currently following the laws and procedures of the Customs Authority and the Ministry of Industry. This requires that an agent is established in Turkey to import medical equipment and place this medical equipment on the market. The agent must have a license to import and be authorized to and be able to offer after-sales facilities to make sure that the repair maintenance and supply of spare parts can be met.
Standards Compliance
Certain medical equipment is authorized by the Turkish Standards Institute. Devices must comply ISO 9000 or U.S./EU equivalent. Generally, medical devices that have either a CE Mark or FDA approval may be freely sold in Turkey.
Labeling
The current system there is no language restriction for medical instructions on medical equipment. Both Turkish and English are used but Turkish is generally preferred. However, with the new regulations, the Turkish language will become obligatory.
Future System
The Turkish government is working toward a new law establishing requirements for medical devices similar to the EU Medical Devices Directive. Although Turkey is not a member of the EU, it does have a Customs Union between itself and Europe.
Contacts
Regulatory
Agency
Standards
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Last updated on 5-2-05 by JF
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