Unsafe Devices: Recall, Suspension and Revocation in Turkey

1. Key takeaways

Part Nine of the Turkish Medical Device Regulation, Madde 91 through 97, is the statutory chain through which the Kurum handles unsafe and non-compliant devices. The chain runs from evaluation through measures to recording, with the remedy for aggrieved parties located at Madde 93. This article walks the chain, notes the definitions carried by the product safety law, and recalls the sales-side numbers covered in the sales regulation.

• Part Nine of the device regulation (Madde 91—97) is the statutory chain for the Kurum’s handling of unsafe and non-compliant devices: Madde 91 (evaluation on the basis of vigilance and market surveillance data), then Madde 92 (measures may be taken where the evaluation identifies a risk to health or safety), then Madde 94 (handling where the evaluation identifies non-compliance with the regulation), then Madde 95 (measures may target a specific device or a specific category or group of devices), then Madde 96 (measures taken under Madde 92—95 must all be recorded in the electronic system).
• The remedy for a party dissatisfied with a measure taken by the competent authority is set out in Madde 93.
• The terms are defined in the higher-ranking law: Madde 3 paragraph 1 of Law No. 7223 defines market surveillance and inspection (piyasa gözetimi ve denetimi), recall (geri çağırma) and withdrawal from the market (piyasadan çekme) respectively.
• The sales-side disposal numbers were described in article 35 of this series: inspections of sales centres at least once every two years (Madde 27 of the sales regulation), suspension of business for 15 days, 30 days for a repeat within one year (Madde 29), and indefinite revocation with no reissue for two years (Madde 30).

2. Legal basis

The chain rests on three instruments: the device regulation that contains Madde 91—96, the product safety law that supplies the definitions and inspection powers, and the sales regulation that carries the commercial-side sanctions. Their details are recorded below.

3. Expert insights

Insight 1: this is a one-way descending chain, with the remedy only at the end. Evaluation (91), measures (92, 94, 95) and recording (96) form an irreversible advancing sequence, while the appeal mechanism (Madde 93) sits after the measures. The practical consequence is that the most valuable window of action for a company lies at the evaluation stage: supplying full materials during the Madde 91 investigation is more effective than seeking a remedy after the measure has been taken. Companies should therefore treat the evaluation phase as the primary battleground and prepare its inputs in advance.

Insight 2: Madde 95 allows measures to be taken by category or group. This is a power with enormous consequences for companies: the object of disposal need not be a single model but can be an entire product line or an entire group of devices. For Chinese manufacturers with long product lines, a localised problem can drag a whole group of products into the measure. This is precisely why product lines should be segmented in advance by family of devices, so that the blast radius of any single issue is defined and bounded in the documentation.

Insight 3: the recording requirement of Madde 96 means that measures leave a searchable trace. Measures taken under Madde 92—95 must all be recorded in the electronic system. This makes the outcome of any disposal retrievable, and it will be pulled up again in subsequent surveillance and in tender reviews. A recorded measure is thus not a closed episode but a durable fact that follows the product and the company, which raises the stakes of every stage of the chain described above.

4. Practical recommendations

• Build a rapid response package for the Madde 91 evaluation stage: technical argumentation, test reports, clinical data and analysis conclusions on comparable events, all instantly retrievable.
• Segment product line documentation by family of devices to avoid a local event dragging a whole group (with reference to the category disposal power in Madde 95).
• Agree with Turkish partners that, once a measure under Madde 92 appears, the Chinese headquarters must be notified within an agreed time limit, with a simultaneous assessment of suspension and licence revocation risks on the sales side.
• Keep the Madde 93 remedy route and its time limits documented, so that any appeal decision can be taken quickly and on full information.
• Pre-agree with Turkish counsel the evidentiary format for the Madde 91 evaluation stage, so that materials submitted during the investigation are in the form the authority expects.

5. Verification checklist

• □ A disposal response process aligned with Madde 91—96 has been established.
• □ A technical argumentation package that can be submitted instantly at the evaluation stage is ready.
• □ The remedy route of Madde 93 and its time requirements are known.
• □ Product lines have been segmented by family of devices to limit the reach of Madde 95.
• □ The sales-side consequences of 15-day suspension, 30-day repeat suspension and the two-year ban have been checked and written into distribution agreements.

Regulatory information verified as of 29 October 2026. The provisions of Madde 91—96 cited in this article were checked against the current text on the Turkish legislation information system (MevzuatNo 38657); the issue numbers, dates and provisions of Law No. 7223 and the sales regulation were checked against the original texts of the Resmî Gazete.

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 manages adverse event reporting and recall coordination with TITCK, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com