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Legal Alerts
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Turkey Cracks Down on Unsafe and Non-Compliant Medical Devices and Cosmetics Products – March 2017

Legal Alerts
Healthcare
General

Recent Development

On March 7, 2017, the Turkish Medicines and Medical Devices Agency (TİTCK) announced the Q4 results of its market oversight in the medical devices and cosmetics sectors, carried out between October and December 2016. Of the 1,816 products inspected, 1,213 have been detected as unsafe or non-compliant, and a total fine of TRY 1,317,396 (approximately USD 353,000) has been levied against the companies responsible.

What happened?

The Medical Devices Supervision Department of the TİTCK has cracked down on unsafe and non-compliant medical devices. Of the 1,325 inspected medical devices, 61 have been declared unsafe and 742 have been declared non-compliant; a total fine of TRY 1,079,700 (approximately USD 289,000) has been applied to medical devices companies. The complete Q4 list of unsafe and non-compliant medical devices (including their lot numbers and barcode numbers) is available here (in Turkish). The Cosmetics Supervision Department of the TİTCK has cracked down on unsafe and non-compliant cosmetics products. Of the 491 inspected cosmetics products, 211 have been declared unsafe and 199 have been declared non-compliant; and a total fine of TRY 237,696 (approximately USD 64,000) has been applied to cosmetics companies. The complete Q4 list of unsafe and non-compliant cosmetics products is available here.

Conclusion

The TİTCK has continued to demonstrate its commitment to periodical market oversight in the healthcare sector. All pharmaceuticals, medical devices and cosmetics products in circulation must fully comply with the applicable Turkish laws and regulations; and manufacturing companies must ensure that they do not sell or distribute unsafe or non-compliant products.