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Notice No: 2020/KK-2
Amending Notice 2019/KK-9 on Applications For Registration
of Medical Devices and Certificates Thereof
THE PHARMACEUTICALS & MEDICAL DEVICES AGENCY OF TURKEY,
Having regard to the current practice toward registering medical device
products that are placed on the market under the Medical Device Regulations
and Certificates thereof through the Product Tracking System (PTS) as effected
from 06/12/2017 by virtue and mandate of the official determination letter of
06/02/2017 with ref. E.1967 for the Opening Of Medical Device Registration
Screens of the PTS;
Acknowledging the subsequent need for amending certain requirements,
especially by making additions to a number of parts, in lieu of the resultant conclusions of reviews made on the “Notice 2019/KK-9 Amending Notice 2019/KK8 on Applications For Registration of Medical Devices and Certificates Thereof ”,
as published on 07/09/2019;
Has adopted a change, with effect from 03/01/2020, to the rules governing applications for the registration of medical devices and their certificates
as follows:
Notice No: 2020/KK-2
Amending Notice 2019/KK-9 on Applications For Registration
of Medical Devices and Certificates Thereof
THE PHARMACEUTICALS & MEDICAL DEVICES AGENCY OF TURKEY,
Having regard to the current practice toward registering medical device
products that are placed on the market under the Medical Device Regulations
and Certificates thereof through the Product Tracking System (PTS) as effected
from 06/12/2017 by virtue and mandate of the official determination letter of
06/02/2017 with ref. E.1967 for the Opening Of Medical Device Registration
Screens of the PTS;
Acknowledging the subsequent need for amending certain requirements,
especially by making additions to a number of parts, in lieu of the resultant conclusions of reviews made on the “Notice 2019/KK-9 Amending Notice 2019/KK8 on Applications For Registration of Medical Devices and Certificates Thereof ”,
as published on 07/09/2019;
Has adopted a change, with effect from 03/01/2020, to the rules governing applications for the registration of medical devices and their certificates
as follows:
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