Medical Device Sales Representative Rules in Turkey

In Turkey, the people who sell and promote medical devices must be qualified. A sales and promotion representative (Satış ve Tanıtım Elemanı, STE) is a person who sells and presents the devices of a medical device sales centre and who holds a qualification certificate obtained through training and an examination. Every sales centre must have at least one. For a foreign company entering the Turkish market this affects staffing directly: the sales team of your Turkish subsidiary or distributor has to be trained and certified before it can visit hospitals, clinics and dealers.

For the sales and promotion representative qualification, apply to CE Danışmanı (CE Consultant); we manage the whole process for you.

Legal basis

The Regulation on the Sale, Advertising and Promotion of Medical Devices entered into force on 15 May 2014. It requires every business that sells medical devices to hold a sales centre authorisation. One of the conditions is that the business employs trained and examined staff:

• a responsible manager,
• at least one sales and promotion representative,
• clinical support staff, where the product group requires it.

Who has to be trained?

• All staff who carry out sales and promotion of medical devices
• All staff who give clinical support because of the nature of the products sold
• Medical device registration staff who make entries in ÜTS (Ürün Takip Sistemi, the Product Tracking System), where the UDI-DI of each product is also entered
• The responsible manager of the business

A separate training field and a separate examination exist for each of these roles. A person who applies for more than one role takes each examination separately.

Eligibility

For employees who studied outside Turkey, the equivalence document should be requested early.

Steps to the qualification

1. Registration. The candidate registers with identity and contact details in TCESIS, the medical device training system operated by the continuing education centre of Sakarya University.
2. Application. The training field is selected, the graduation details are entered and the documents are uploaded as PDF files. The undertaking is accepted and the application is completed.
3. Approval and enrolment. After approval and payment for the training and examination, the candidate is placed in the next training group and is notified when it opens.
4. Training. The training is delivered online. The examination is opened only for candidates who have completed the training. Applications of candidates who do not complete it are cancelled.
5. Examination. Candidates who complete the training sit the examination on the announced dates. A candidate who fails is given a further attempt. If that is also unsuccessful, the application is cancelled and a new application is needed.
6. Qualification certificate. Successful candidates are entitled to the qualification certificate issued by TİTCK (the Turkish Medicines and Medical Devices Agency).

What the training covers

The training has two parts.

Legislation

• What a medical device is, and the classification criteria and categories
• National and international legislation, including the Regulation on the Sale, Advertising and Promotion of Medical Devices, the Medical Devices Regulation and the rules on clinical investigations
• Market surveillance and inspection: who inspects and how
• Rules, prohibitions and limits for advertising and promotion
• Sales authorisations and the qualification certificates required of staff
• Recall and withdrawal procedures, and disposal of devices at the end of their life
• Handling complaints and reporting incidents

Medical ethics

• Patient rights: autonomy, informed consent, privacy and confidentiality of health information
• Professional conduct in the sale and promotion of medical devices
• Honest, complete and impartial information; avoiding misleading claims
• Preventing and managing conflicts of interest

What the representative does

• Presents the devices and explains their technical characteristics and intended use
• Gives customers and healthcare professionals the information needed for correct and safe use
• Collects feedback and complaints and passes them to the responsible units
• Keeps the records of sales and promotion activities
• Acts in line with the medical device legislation and follows changes to it

Sales representative and responsible manager

The two roles are separate. A two-year associate degree is enough for a sales and promotion representative. A responsible manager needs a four-year degree, or at least four years of experience as a sales and promotion representative or as clinical support staff. Both roles must be filled for the sales centre to receive its authorisation.

How CE Danışmanı helps

• Checking the eligibility of your staff, including foreign diplomas
• Managing registration, training and examination for the whole team
• Coordinating the qualification with the sales centre authorisation and ÜTS registration

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

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