2021 /KK-4 Apostille or Temporary Announcement Amending the Temporary Announcement 2020 /KK-9 regarding the Documents Requested to be Submitted with Physical Documents as Approved by the Embassy/Consulate
As is known, it is dated 02/06/2017 and has an E.Since 12/06/2017, together with the authority No. 1967 and the Opening of the Product Tracking System (UTS) Medical Device Registration Screens, records of medical devices and related documents released to the market within the scope of the Medical Device Regulations are carried out through UTS. As you are aware, the Document No. 2020 / KK-2 on Medical Device Registration and Medical Devices dated 05/02/2020 regarding applications for registration of documents for medical devices and medical devices
The Announcement titled ”Announcement Amending the Announcement No. 2019/KK-9 regarding Registration Applications" is already in force and will remain in force until a new one is received. However, in accordance with the Announcement “2020 /KK-9 No. 2020 /KK-2" dated 04/12/2020, which is currently in force, as an Apostille or Embassy/Consulate Approved
Document registration applications requiring an apostille or an embassy/consulate approval process that cannot be completed EC Certificate and physical documents of Conformity types that meet the other requirements in the relevant Announcement are accepted and granted a 120-day extension based on the Announcement called ”Provisional Announcement Amending the Provisional Announcement No. 2020/KK-5 regarding Documents Requested to be Applied For with Physical Documents". For documents that cannot be completed apostille approval or embassy/consular approval procedures due to the COVID-19 pandemic within the given 120-day period, see 2020/KK-9
If an application is made for an extension of the period as mentioned in the announcement and in accordance with the provisions of the Announcement No. 2020 / KK-1, an extension of another 60 days is granted. In contrast, what has been described as a “global pandemic" by the World Health Organization is
It seems that the general course of the COVID-19 pandemic process is progressing positively and therefore apostille approval or embassy/consulate approval processes are approaching normal conditions. For this reason, there has been a need to reorganize and amend the provisions of the Provisional Announcement No. 2020/KK-9. In this context;
1- from 01/02/2022 and until the publication of a new Announcement on the subject, applications for registration of documents requiring an EC Certificate and physical documents of Conformity Declaration types that cannot be completed due to the COVID-19 pandemic apostille or embassy /consulate approval processes will continue to be accepted. Accordingly, as a result of the evaluation of the documents uploaded to the system in accordance with the provisions other than the apostille of the Announcement No. 2020 /KK-2 or the conditions of embassy /consular approval and submitted to the Institution in their physical state, the registration process will be completed, if appropriate, and the extension of 120 days will continue to be granted to these documents.
As of 01/02/2022, as of 2- 01/2020, no additional time extension will be granted in any way in accordance with the provisions of the Announcement “Announcement Amending Announcement 2019 / KK-6 on Defining the Period of Stay in the System for Products Related to Documents that have Expired or Are About to Expire Document 2020 / KK-1”.
Due to the situation mentioned in section 3- (2-), an additional extension of time will not be granted for documents that have been granted an extension of 120 days in accordance with section (1-). This
in this context, an application for document registration will be required to be submitted as an apostille or embassy/consulate approved in accordance with the provisions of the Announcement No. 2020 /KK-2 within the period given for the documents in question.
4- from 01/02/2022 and until the publication of a new Announcement on the subject, apostille or embassy/consular proceedings due to the COVID-19 pandemic
applications for registration of documents that do not require physical documents of the types of incomplete Quality Management System (ISO 13485) Certificate, Authorized Distributorship Certificate and SIP Declaration (MDR) will continue to be accepted. Accordingly, as a result of the evaluation of the documents uploaded to the system in accordance with the provisions other than the apostille of the Announcement No. 2020 / KK-2 or the conditions of embassy / consular approval, the registration process will be completed, if appropriate.
5- For applications for documents with apostille or embassy /consular approval, or for applications for documents other than (1-) and (4-), No. 2020 / KK-2
Registration procedures will be continued in accordance with the announcement.
6- This Announcement will be effective from 01/02/2022.
7- As of 01/02/2022, in Accordance with the Announcement “2020 / KK-9 No. 2020 / KK-2 dated 04/12/2020 As an Apostille or Embassy/Consulate Approved" dated 01/02/2022
The Announcement called ”Provisional Announcement Amending the Provisional Announcement No. 2020 /KK-5 regarding the Documents Requested to be Applied For in a Physical Form" will be cancelled.
8- From 01/02/2022, the Announcement dated 05/02/2020 called “Announcement Amending the Announcement No. 2019 /KK-6 on Defining the Period of Stay in the System for Products Related to Documents that have Expired or are About to Expire Document No. 2020 / KK-1” will be canceled.
9- With the publication of a new Announcement on the issue, this Announcement will be canceled.
10- "Announcement Amending the Announcement No. 2019 /KK-9 on Medical Device Registration and Document Registration Applications No. 2020 /KK-2 dated 05/02/2020 and dated 05/2020
The announcement will remain in effect until another Announcement is published in its place.
SOURCE: https://titck.gov.tr/storage/Archive/2021/announcement/2021KK4SaylDuyuruMetni1_4c5d8899-374b-4990-9ee4-50ce83c26f83.pdf
24 Dec 2021
