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).