Notice 2023/KK-4
Amending Provisional Notice 2021/KK-4 that amends Provisional Notice 2020/KK-9 on Apostille-Bearing or Em-bassy/Consular Office-Approved Physical Document Submission Requirements For Medical Device Product Registration/Update/Revision Applications within the Product Tracking System

The Pharmaceuticals and Medical Devices Agency of Turkey, representing the Turkish Ministry of Health,
Having due regard to the official letter of affirmation dated 2 June 2017 with Ref. E-1967 for The Launch Of Medical Device Registration Screens Of the Product Tracking System (PTS), which introduces and implements, as effective from 12 June 2017, a proactive change in the conventional methods of registration and record-keeping of Medical De-vice Products that are placed on the market under the Regulations in effect that cover Medical Devices and of relevant documentation supplied by a permanent shift from on-paper towards electronic submission procedures;
Bearing in mind that all inquiries for the registration of certificates/documentation belonging to medical device products are, and will continue to be, subject to requirements of the Notice 2020/KK-2 of 6 September 2022 Amending Notice 2020/KK-1 (still effective) on Medical Device Product and Certificate/Document Registration Applications, as currently in force;
Whereas, pursuant to the Notice 2021/K-4 of 23 December 2021 Amending Provisional Notice 2021/KK-4 that amends Provisional Notice 2020/KK-9 on Apostille-Bearing or Embassy/Consular Office-Approved Physical Document Sub-mission Requirements For Medical Device Product Registration/Update/Revision Applications within the Product Tracking System, which is currently in effect (“Provisional Notice 2021/KK-4”) , and by reason of the globally spread COVID-19 outbreak, any incoming applications and submissions on paper for certificate/documentation registration purposes are readily admitted for due process save, to the extent, that the certificates/documentation in question bear valid Apostille stamps or internationally recognised and verifiably authentic attestation seals of embassies/consular of-fices of the certificate-issuing/documenting countries or countries from which the products for which relevant registra-tion entries are sought would originate, and with reference, in particular, to the one-time extension of 120 days granted to procedural deadlines for submissions of documents relating to medical devices exempted from the requirement of bearing the aforesaid Apostille stamps or Embassy/Consular Office approval seals as imposed by Notice 2022/KK-1, whilst still being subject to on-line uploads to the electronic system of records of photo-static images and physical de-liveries thereof reaching the Agency on time;