Medical Device Responsible Manager in Turkey

Every medical device sales centre in Turkey must have a responsible manager (sorumlu müdür, in everyday use also “mesul müdür”). This is the person who answers for the compliance of everything the centre does, and who has completed the training and passed the examination required by the Regulation on the Sale, Advertising and Promotion of Medical Devices, in force since 15 May 2014. For a foreign company the consequence is practical: your Turkish subsidiary or distributor cannot obtain its sales centre authorisation, and therefore cannot sell your devices, until a qualified responsible manager is in place.

For the responsible manager qualification, apply to CE Danışmanı (CE Consultant); we manage the whole process for you.

What a foreign company should plan for

• At least one responsible manager is required for each sales centre.
• The qualification certificate belongs to the person, not to the company. If the responsible manager leaves, a new qualified person has to be appointed and the change notified.
• A manager with a degree from a university outside Turkey can qualify, but needs a diploma equivalence document from YÖK (the Council of Higher Education).
• Training and examination dates are fixed by the training provider, so the appointment should be planned before the authorisation application.

Who can become a responsible manager?

One of two routes is required:

In both cases the responsible manager training and examination must be completed successfully.

Who else has to be trained?

• One responsible manager in every business active in the medical device sector
• All staff who carry out sales and promotion of medical devices: see sales and promotion representative qualification
• All staff who give clinical support, where the product group requires it
• Medical device registration staff authorised by the sales centre to make entries in ÜTS (Ürün Takip Sistemi, the Product Tracking System), including the UDI-DI of each product

Steps to the qualification

1. Registration. The candidate registers in TCESIS, the medical device training system operated by the continuing education centre of Sakarya University, and selects the training field: responsible manager, sales and promotion representative, clinical support staff or medical device registration staff.
2. Documents. The graduation documents, or the official letter on the period of service, are uploaded as PDF files and the undertaking is accepted.
3. Approval and enrolment. Once the application has been approved and the training has been paid for, the candidate is placed in the next training group and is notified when it starts.
4. Training. Completing the training is a precondition for the examination. It is not sufficient on its own.
5. Examination. Examinations are held remotely at the end of each training period. A candidate who fails is given a further attempt. If that is not used or not passed, the application is cancelled and the candidate has to apply again.
6. Qualification certificate. Successful candidates are entitled to the qualification certificate of TİTCK (the Turkish Medicines and Medical Devices Agency) and apply for it in line with the guideline on the application of the Regulation published by the agency.

The certificate remains valid until a new regulation provides otherwise.

Duties of the responsible manager

• Ensuring that all activities of the sales centre comply with the legislation
• Supervising how devices are procured, stored, distributed and sold
• Keeping the records and documents of the devices in order
• Making sure that sales, delivery and stock records are accurate and complete
• Informing and training the staff on the correct use of devices and on the legislation, including new rules
• Checking the conformity of devices where necessary and taking measures when a non-conformity is found
• Providing the information and documents requested by TİTCK correctly and on time
• Evaluating complaints and feedback, and carrying out corrective and preventive actions
• Following ÜTS registrations and managing recalls

Responsible manager and sales representative

These are two different roles with different conditions. A two-year associate degree is sufficient for a sales and promotion representative. A responsible manager needs a four-year degree or four years of experience. A sales centre has to fill both roles to receive its authorisation.

How CE Danışmanı helps

• Checking whether your candidate meets the conditions, including foreign diplomas
• Managing the application, training and examination steps
• Applying for the qualification certificate
• Continuing with the sales centre authorisation and ÜTS registration

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

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