Clinical Investigation Approval Timelines of 20 and 30 Working Days in Turkey

1. Key takeaways

Clinical investigations in Turkey run under a regulation of their own, separate from the device regulation, and its timelines are written into the text as concrete working-day counts rather than left to practice. This article collects the approval rule, the review deadlines, the ethics committee requirement and the safety reporting deadlines in one place, since planning a Turkish clinical investigation requires all of them simultaneously. A schedule that captures one of these elements while missing another will fail at the stage that was left unplanned.

• Turkey has a regulation independent of the device regulation: the Regulation on Clinical Investigations of Medical Devices (Tıbbi Cihaz Klinik Araştırmaları Yönetmeliği), published in Resmî Gazete No. 31890 of 8 July 2022. It forms the primary frame for running device clinical investigations in Turkey.
• A clinical investigation must not be started without TİTCK approval (Madde 7 paragraph 1 (a), (c)). The prohibition is express, which makes approval a hard gate in the project plan rather than a formality to be assumed.
• The review timelines are explicit:
  • Initial application: 20 working days (Madde 7 paragraph 1 (b));
  • Substantial modification: 30 working days (Madde 11 paragraph 1 (b));
  • Non-substantial modification: 30 working days (Madde 16 paragraph 1 (b)).
• The ethics committee is a mandatory stage in every investigation: Madde 21; a multicentre investigation produces only a single ethics committee decision (Madde 8 paragraph 2).
• The safety reporting timelines are equally explicit: 7 days for urgent safety measures (Madde 18 paragraph 1); the report on the recollection of devices from the investigation after a suspension for safety reasons is due within 15 days (Madde 15 paragraph 1 (e)).

2. Legal basis

The primary instrument is the clinical investigations regulation, which carries the approval rule, the timelines, the ethics provisions and the safety reporting duties. The vigilance and safety reporting framework of the device regulation stands behind it. Both instruments are recorded below with the exact articles relied on.

3. Expert insights

Insight one: Turkey has written the prohibition on starting early into the text of the law. The prohibitive wording of Madde 7 paragraph 1 (a)(c) leaves no room for ambiguity. Unlike some markets that permit starting after a filing has been made, Turkey requires the approval to exist first, and scheduling must therefore treat the approval as a milestone that cannot be skipped or compressed. Any recruitment activity that starts before approval is not a scheduling risk but a violation.

Insight two: the gap between 20 and 30 working days should shape the modification strategy. The initial application takes 20 working days, while a substantial modification takes 30 working days, meaning that a modification is actually slower than the original approval. This inversion carries a clear planning lesson: rather than making substantial revisions during the investigation, it is better to invest in getting the design right at the initial protocol preparation stage. Every avoided substantial modification saves a full review cycle on the slower track.

Insight three: the single ethics decision reduces friction for multicentre investigations. Madde 8 paragraph 2 converges the ethics review of a multicentre investigation into one decision, avoiding the time drag caused by repeated review at each centre. For companies that wish to run investigations at multiple sites, this is a substantive convenience, because the ethics clock runs once instead of running in parallel at every site, and the risk of divergent committee comments across centres disappears along with it.

Insight four: CE-marked devices may have room for an insurance exemption. Madde 5 paragraph 9 provides that for devices that have been CE marked and are used in accordance with their intended purpose, the ethics committee may waive the subject insurance requirement. This provision is frequently overlooked, yet it has a direct impact on the investigation budget, and it should be raised affirmatively in the ethics submission rather than assumed.

4. Practical recommendations

• Set the TİTCK approval date as a hard node in the Gantt chart, and prohibit any subject recruitment activity before that date, so that the statutory gate is respected in every project schedule.
• Invest more resources at the protocol preparation stage to avoid triggering the 30-working-day substantial modification channel during the investigation, since the slower track is the more expensive one in every dimension.
• For devices that already bear CE marking and are used according to their intended purpose, raise the request for the insurance exemption in the ethics review materials (Madde 5 paragraph 9), turning an available waiver into a budget saving.

5. Verification checklist

• □ It has been confirmed that the investigation requires TİTCK approval before it may start (Madde 7 paragraph 1).
• □ The timelines have been scheduled as 20 (initial) / 30 (modifications) working days.
• □ The ethics committee review has been completed, and the multicentre investigation obtained a single ethics decision.
• □ The actions for the 7-day urgent safety measures and the 15-day post-suspension recollection report have been written into the SOPs.
• □ For CE-marked devices, the applicability of the insurance exemption under Madde 5 paragraph 9 has been assessed.

Regulatory information verified as of 29 October 2026. The gazette numbers, dates and provisions cited in this article (including the working-day and deadline figures) 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