Dear Stephane,
Our importer/distributor in Turkiye registered our Class I devices for us. Through a regulatory watch I found this and the importer concurred that it was correct as to what we needed in February of this year.
TITCK published Announcement No. 2021/KK-4, which amends the provisions of Announcement No. 2020/KK-9 regarding the Apostille/legalization of certain documents for medical device registration. Some of the notable provisions are as follows:
- CE Marking Certificates, Declarations of Conformity, ISO 13485 Certificates, Authorized Distributorship Certificates, and SIP Statement (MDR) without Apostille/legalization will continue to be accepted due to the COVID-19 pandemic
- A 120-day extension for the submission of the Apostilled/legalized documents will continue to be granted, as well
- No additional extension will be given for those documents that have been given a 120-day extension
These provisions will be applicable from February 1, 2022 and until a new announcement is published.
We do not have CE marking certificates either. We provided our distributor: DoC, ISO certificate, Importer Agreement and a pdf of each product label showing each product number we were registering. They now have all our products registered in Turkiye.
Regards,
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D Michelle Williams
VP - Operations
United States
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Original Message:
Sent: 20-Dec-2022 05:06
From: Stephane Berger
Subject: Registration of CE Class I Medical Device in Turkey
No one has registered a Class 1 device in Turkey?
Thank you in advance for your help!
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Stephane Berger
La Ciotat
France
Original Message:
Sent: 08-Dec-2022 08:50
From: Stephane Berger
Subject: Registration of CE Class I Medical Device in Turkey
Hello,
we would like to register our auto-certified class 1 product in Turkey.
We have a local distributor who act as Turkish representative and register our product into TITUBB via MoH portal.
There are two steps during product registration on TR MoH portal:
1- Document approvals
2- Medical Device Registration
There was no issue to pass the first step.
During second step it requires a CE certificate that we don't have as we are auto-certified (we just have a Declaration of Conformity and a notification of "put onto market" from our competent authority: ANSM but it seems that it is not accepted)
Does anyone already register a class 1 device in Turkey?
How to pass this step on MoH portal?
Thank you.
Stephane.
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Stephane Berger
La Ciotat
France
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