Recent developments

In mid May, 2017, the Turkish Medicines and Medical Devices Agency (“TİTCK”) announced the Q1 results of its market surveillance and inspection conducted in the medical devices and cosmetics sectors between January and March 2017.

Of the 1,253 medical devices and cosmetic products inspected in total, 509 have been detected as unsafe or non-compliant, and a total fine of TRY 773,657 (approximately USD 216,200) has been levied against the companies responsible.

What the Results Say

The Medical Devices Supervision Department of the TİTCK announced that of the 494 inspected medical devices; 12 have been declared unsafe and 175 have been declared non-compliant. A total administrative fine in the amount TRY 229,710 (approximately USD 64,200) has been imposed on medical device companies. The complete Q1 list of unsafe and non-compliant medical devices (including their lot numbers and barcode numbers) is available here (in Turkish).

Further, the Cosmetics Supervision Department of the TİTCK has also announced the unsafe and non-compliant cosmetics products detected during the first three months of 2017. Of the 759 inspected cosmetic products, 12 have been declared unsafe and 310 have been declared non-compliant; and a total fine of TRY 543,947 (approximately USD 152,000) has been applied to cosmetic companies. The complete Q1 list of unsafe and non-compliant cosmetics products is available here.

The results for medical devices reveal in general that the number of unsafe medical devices has remarkably decreased compared to the Q3 results of 2016, and thus leading to a significant decrease in the administrative fines as well. However, the results for cosmetic products do not reveal the same improvement; while the number of the unsafe cosmetic products has also decreased notably, the increase in the number of the cosmetic products that are declared non-compliant and the total amount of the administrative fines imposed proves that the cosmetic companies should act more carefully to ensure compliance of their products.

Conclusion

The TİTCK continues to demonstrate its commitment to periodical market surveillance and inspection in the healthcare sector. All pharmaceuticals, medical devices and cosmetic 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.