In Vitro Diagnostic Medical Device in Turkey Registration

[xgg810116]

Does anyone have experience on In Vitro Diagnostic Medical Device in Turkey?

Does Turkey have special directive for IVDD?, or only follow 98/79/EC?

Thanks!

 

[xgg810116]

Is it necessary to register the IVDD in Turkey, when import this product?

Does anyone have experience on it?


Thanks!

 

[Gert Sorensen]

Re: In vitro diagnostic in Turkey

As a candidate for European Union membership, Turkey has aligned its medical device regulations closely with those in the EU. The Turkish Ministry of Health regulates requires CE Marking for all devices imported into Turkey. Manufacturers must also have proof of conformity to EU requirements and register in the TUBB in order to sell them in the Turkish market.

MD and IVD are regulated by the Turkish Medical Devices Directive, which is a transposition of the EU Medical Devices Directive MDD 93/42/EEC (as amended by 2007/47/EC).

 

[Gert Sorensen]

MD and IVD must be registered with the Turkish authorities in the TUBB.

 

[Marc]

Threads merged.