Article 117 of (EU) 2017/745 Medical Device Regulation (MDR) requires manufacturers who market drug-device combination products as an integrated device...
MOREThe Turkish Medicines and Medical Devices Agency has published answers to frequently asked questions regarding the extension process under Regulation (EU) 2023/607.
MOREWith the Regulation (EU)2023/607, the validity periods of MDD certificates have been extended, provided that certain conditions are met.
MOREYou can access the Technical Documentation Content Guide, which we have prepared for the purpose of informing manufacturers, taking into account the MDCG 2022-14 guide and referencing the Team-NB Position Paper...
MOREYou can have a look at the details of our new to see the Announcement Notification for the Medical Device Arrangement Process.
MOREAs of May 26, 2021, Approved Institutions appointed under 93/42/EEC Directive will not be able to have another first certification but it has been announced...
MOREWe crown our achievements with originality with our sector experience and expert personnel, we continue to be the choice of professionals.
Without compromising our principles of impartiality, independence and confidentiality, we aim to be a leader not only in Turkey, but also in the global market, we are expanding our international network every day.
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