MEDICAL DEVICE REGISTRATION


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MEDICAL DEVICE REGISTRATION

Medical device UTS registration process:

ÇKYS license:

It is obligatory to obtain a ÇKYS license for UTS registration of Medical Devices. Otherwise, it is not possible to register via ÜTS. For the ÇKYS license, the relevant procedures must be initiated from the Provincial Health Directorate.

Requirement for staff:

With the Medical Device Sales, Advertisement and Promotion Regulation, which was published in the Official Gazette on May 15, 2014, it became mandatory for businesses that sell medical devices to obtain a certificate of authorization to continue their activities. In order to obtain a certificate of authorization, businesses are required to fulfill a number of conditions.

In all businesses operating in the Medical Device sector and wishing to be authorized:

– The responsible manager and the personnel who carry out sales and promotion and clinical support activities must be trained and certified.

You can benefit from the services of the Responsible Manager, Sales and Promotion Personnel and Clinical Support Personnel within the OzeCo Group.

After meeting the ÇKYS license and the conditions for personnel, a Sales Center Authorization Certificate is issued by the Provincial Directorate.

Please contact us to get support from our expert team for your registration, permit and license procedures required by the Turkish Medicines and Medical Devices Agency (TİTCK).

Company Registration

(1) The registration of companies (medical device sales center, manufacturer/importer, optician establishment, hearing center, custom-made prosthesis-orthotics center, pharmacy, pharmacy warehouses, etc.) to UTS, which sells and/or implements medical devices, is carried out if they are authorized by the relevant legislation. .

(2) Company records are made from MERSIS or VEDOP.

Document registration

The records of the following documents, which are issued in accordance with the provisions of the Medical Device Regulation, are made.

➡️EU Declaration of Conformity

➡️EU Certificate / CE certificate

➡️Quality Management Documents

➡️User manual

➡️Purpose of Use Form/Statement

➡️Domestic Goods Certificate

➡️Authorized Distributorship Certificate

Product registration

Product registration is performed together with the label and product images of the approved product.

As OzeCo Group, our services in UTS registration processes;

1. Medical device UTS records

2. Medical Device Manager, Sales and Promotion Staff, Clinical Support Staff Hiring Service

3. Obtaining a Free Sales Certificate for exported products

4. Preparation of Product Technical File within the Scope of MDR

5. Coordination with authorized institutions for certification processes

Please contact us to get support from our expert team for your registration, permit and license procedures required by the Turkish Medicines and Medical Devices Agency (TİTCK).