Our Information Note on the new developments concerning the export of certain medical devices has been published.

1. INTRODUCTION

Respiratory devices and certain other medical devices which are necessary within the Republic of Turkey due to the outbreak of the COVID-19 pandemic have been included in the “List of Export Goods which are subject to Prior Authorisation” by way of the Communiqué (numbered 96/31) Amending the Communiqué on Goods the Export of which is Prohibited or Subject to a Prior Authorisation (numbered 2020/6), published in the Official Gazette 26 March 2020 and numbered 31080 (the “Communiqué”).

2. MEDICAL DEVICES INCLUDED IN THE LIST OF EXPORT GOODS WHICH ARE SUBJECT TO PRIOR AUTHORISATION

According to the Communiqué, the export of the following items put on the market on the basis of the Regulation on Medical Devices, published in the Official Gazette dated 7 June 2011 and numbered 2795, have been subjected to a prior authorisation as of 26 March 2020:

• ventilators;


• ECMO devices;


• oxygen concentrators;


• ventilation consumables;


• expiration valves;


• oxygen sensors;


• ventilation circuits;


• patient circuits (anaesthesia/ventilation circuits);


• cannulas;


• intubation tubes; and


• intensive care monitors.

Pursuant to the Communiqué, a prior authorisation for the export of such goods must be obtained from the Turkish Pharmaceuticals and Medical Devices Agency. In the absence of such authorisation, the export and custom declaration registration of the relevant good will not be possible.

3. CONCLUSION

The number of patients in need of medical care due to the COVID-19 pandemic increases daily which is why the availability of certain medical devices gains critical importance. The abovementioned amendment that is intended to control the export of certain medical devices therefore constitutes an important and appropriate approach in the country’s fight against this pandemic.