Medical Device Sales Centre Authorisation in Turkey

A company that sells, imports or distributes medical devices in Turkey must hold a medical device sales centre authorisation (Tıbbi Cihaz Satış Merkezi Yetki Belgesi). It is issued by the provincial health directorate under the Regulation on the Sale, Advertising and Promotion of Medical Devices, which entered into force on 15 May 2014. For a foreign manufacturer this is the first link in the chain: without the authorisation, your importer or your own Turkish company cannot register in ÜTS (Ürün Takip Sistemi, the Product Tracking System), and without ÜTS registration your devices cannot be placed on the Turkish market.

For the medical device sales centre authorisation, apply to CE Danışmanı (CE Consultant); we manage the whole process for you.

What it means for a foreign company

• The authorisation is given to a legal entity or sole trader established and registered for tax in Turkey. A manufacturer abroad sells either through an authorised importer or distributor, or through its own Turkish company.
• If you appoint a distributor, check that it already holds the authorisation and is registered in ÜTS.
• If you set up your own company, the authorisation has to be obtained before any device is sold.
• Online sales are covered as well. A physical shop is not required for e-commerce, but the storage conditions, the responsible manager and the authorisation are.

Who has to hold the authorisation?

Without the authorisation a company cannot register in ÜTS, cannot sell to health institutions and cannot carry out retail or wholesale distribution.

Main conditions

1. Responsible manager. The centre must employ a responsible manager who has completed the required training and passed the examination.
2. Sales and promotion representative. At least one qualified sales and promotion representative is required. Depending on the product group, clinical support staff may also be needed.
3. Suitable premises. Storage conditions appropriate to the devices sold.
4. Tax registration. A company or a sole trader registered in the province where the application is made.
5. Documentation. Procedures and records for product tracking, sales, deliveries and stock.

How the application works

1. Preparation. Employing the responsible manager and the sales representative, arranging the premises and preparing the documents. This usually takes 2 to 4 weeks, longer if the staff still have to complete training and the examination.
2. Application. The file is submitted to the provincial health directorate of the province where the company is registered for tax.
3. Review and inspection. The directorate examines the file and inspects the premises. If deficiencies are found, the applicant corrects them.
4. Authorisation. When the conditions are met, the directorate issues the authorisation.

Application and inspection typically take a further 2 to 4 weeks, so the whole process usually runs for 4 to 8 weeks. Missing documents or unsuitable premises extend it.

Who does what?

• TİTCK (the Turkish Medicines and Medical Devices Agency, under the Ministry of Health) is responsible for medical device legislation and runs ÜTS.
• The provincial health directorate receives the application, inspects the premises and issues the sales centre authorisation.

Changes after the authorisation

A change of responsible manager, a change of address or a change in the scope of activity has to be notified, and the authorisation is revised. The conditions must be met for as long as the company sells devices. The provincial health directorates carry out the inspections.

Next step: ÜTS registration

The two processes are consecutive:

1. Sales centre authorisation from the provincial health directorate
2. Company registration in ÜTS with TİTCK
3. Product registration in ÜTS for each device, with the CE certificate, the Declaration of Conformity and the label information. The UDI-DI of the product is entered at this stage.

The devices themselves must carry valid CE marking. If the conformity documents are incomplete, see medical device testing.

How CE Danışmanı helps

• Assessing whether your distributor or your own company meets the conditions
• Planning the training and examination of the responsible manager and the sales staff
• Preparing the application file and the premises for inspection
• Following the application with the provincial health directorate
• Continuing with ÜTS company and product registration

Tell us about your company and your products, and we will reply with our offer as soon as possible.

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