Sales Centre Authorisation under the 2014 Turkish Sales, Advertising and Promotion Regulation

1. Key takeaways

Sales, advertising and promotion of medical devices in Turkey are governed by a dedicated regulation with its own enforcement machinery, separate from the device regulation itself. This article sets out the legal basis of that regulation after its amendment, and quantifies what non-compliance actually costs in terms of inspection frequency, business suspension and revocation of authorisation. The numbers matter, because they convert abstract compliance duties into concrete business exposures that can be planned for.

• Sales, advertising and promotion in Turkey are governed by a dedicated regulation: the Tıbbi Cihaz Satış, Reklam ve Tanıtım Yönetmeliği, published in Resmî Gazete No. 29001 of 15 May 2014, and amended by the regulation published in Resmî Gazete No. 32202 of 26 May 2023.
• The amended regulation changed the legal basis from the old law to Law No. 7223 on Product Safety and Technical Regulations and Articles 508 and 796 of Presidential Decree No. 4. Citations to the pre-amendment legal basis are therefore outdated and should be updated in all compliance documentation.
• On the sales side there are clear enforcement yardsticks:
  • Madde 27: sales centres are inspected at least once every two years (the Kurum may inspect additionally);
  • Madde 29: closure of the business may be ordered for 15 days; a repeat violation within one year raises this to 30 days;
  • Madde 30: the authorisation certificate may be revoked indefinitely, and may not be reissued for two years.
• Together these figures quantify the cost of non-compliance: the worst outcome of a single violation is not a fine but a 2-year exclusion from the market. Planning for the sales channel therefore has to treat these numbers as real business risks, not as theoretical penalties.

2. Legal basis

Two instruments govern this topic: the original sales, advertising and promotion regulation, and the amending regulation that updated its legal basis. The table below records both, along with the articles that carry the inspection, suspension and revocation rules discussed above.

3. Expert insights

Insight one: at least means a floor, not a ceiling. Madde 27 is worded as at least once every two years, while preserving room for the Kurum to inspect additionally whenever it chooses. For companies this means that no judgement of the form we-were-inspected-recently-so-we-are-safe-for-now exists. The density of inspection is decided by the regulator, and the correct reading of the rule is that a two-year interval is the minimum protection the operator must be permanently ready for, not the maximum exposure it will ever face. Readiness must therefore be continuous rather than event-driven, and the sales centre should be kept at any time in a state in which an unannounced visit could be absorbed without preparation panic.

Insight two: the graduated design of 15 days and 30 days reflects escalation. A repeat violation within one year doubles the closure period immediately. This design makes the effectiveness of the first corrective action the key variable. If substantive rectification has not taken place by the end of the first closure, the cost of the second violation doubles at once. The lesson for operators is that the days between the closure order and the reopening are not dead time; they are exactly the window in which the correction that prevents the doubling must be completed. Treating the first closure as a warning shot rather than as the full sanction is how companies end up paying twice.

Insight three: revocation plus a two-year ban is the truly heavy sanction. The consequence under Madde 30 is that the authorisation certificate is revoked indefinitely and may not be reissued for two years. For companies that depend on local sales channels, this is in substance equivalent to exiting the market. When Chinese manufacturers select Turkish distribution partners, the partner’s sales compliance history should therefore be brought into the scope of due diligence, because the partner’s violations can translate directly into the manufacturer’s loss of a market channel.

4. Practical recommendations

• Put the once-every-two-years inspection into the local operations calendar and prepare qualifications, personnel and records in advance, so that the minimum inspection cycle is met from readiness rather than from reaction.
• Include compliance clauses in the distribution agreement: where the sales centre is ordered to close or its authorisation is revoked, the manufacturer has the right to terminate or to change the channel, protecting the supply line from a partner’s enforcement events.
• Maintain a compliance file for each distribution partner recording its inspection history and corrective actions, and use it as the basis for contract renewal decisions.

5. Verification checklist

• □ It has been confirmed that the regulation applicable to the sales centre is Sayı 29001 (as amended by Sayı 32202).
• □ At least a once-every-two-years self-inspection has been scheduled in the operations calendar.
• □ The distribution agreement contains termination or channel-change provisions for closure or revocation scenarios.
• □ A compliance file and corrective-action records have been established for the distribution partners.
• □ The consequences of closure for 15 days / 30 days and of the 2-year reissue ban after revocation are known and documented.

Regulatory information verified as of 29 October 2026. The gazette numbers, dates and the Madde 27 / 29 / 30 provisions cited in this article were checked against the original texts of the Turkish Official Gazette and the legislative information system.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Turkish market. Our team coordinates authorised representative and importer arrangements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com