In Turkey, the medical device market has been expanding steadily over the past decade in line with the general growth trend in the healthcare service sector. During that period the industry has undergone significant changes; first of all the customer portfolio for the medical device increased and naturally this is followed by the increase in the number of items manufactured/imported and then provided to the market and by the improvement of the quality of the devices. As well, the number of medical device suppliers has increased; many of them for the first time have entered into Turkish market, some others see the opportunity for the direct sale and establish subsidiaries in Turkey after terminating their relations with the distributors in Turkey.
In Turkey, medical devices is legislated under three different regulations issued by Ministry of Health, namely: Medical Devices Regulation, Active Implantable Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation ("Regulations") which are in line with the EU Directives 93/42/EEC, 98/79/EC, 90/385/EEC, respectively. However these major Regulations on the medical devices are silent and do not provide any hint about the importation process for medical devices into Turkey.
Although Communiqué on Import Controls of Medical Devices (2012/16) ("Communiqué") specifically regulates the importation of medical devices, it only regulates certain types of medical devices. For other type of medical devices which is not mentioned in Appendix 1 of the Communiqué, the general import process (customs clearance) as applicable for all other types of commercial products is applicable. This Communiqué is also in line with the EU Directives and regulates the safety and efficiency requirements, conditions of the medical devices to be imported to Turkey. As well as Turkey, the EU increases the demand for better regulatory frameworks to ensure that devices entering the market are safe and efficient, even if they are essential for people's health and quality of life, and the industry that provides them plays a significant role in the economy. New treatment methods and innovative products are not easy to position in the EU market, and for this reason, one of the major issues for companies developing and producing medical devices is to be updated on the regulatory requirements and implement them.
So basically, whether prior permission is required for import of a medical device in Turkey depends on whether the medical devices in mentioned in the Communiqué or not.
Permission for Importation of Medical Devices Listed in the Communiqué
For the medical devices as listed in the Appendix 1 of the Communiqué prior permission is required; so a two-stage process is set forth for the completion of import process of the medical devices mentioned in the Communiqué. Simple saying the first stage is a prior permission stage before the second stage, the custom clearance, which has no difference comparing to the customs clearance of other types of commercial products.
At the prior permission stage the device must be registered to a risk analysis-based, commercial safety control system ("TAREKS") which is an online system established by the Ministry of Economy. This control system mainly targets to increase the efficiency of the trade policy, to provide safe and high quality products to consumers and firms, rationalise the resource allocation vis-à-vis the control of "risky" products and traders, and reduce the waiting periods at customs. After the assessments, if the results are positive TAREKS gives its prior permission to import the device into Turkey so the company becomes eligible to carry out the customs clearance of the medical device.
The Communiqué provides three exceptions to the TAREKS assessment and permission requirement: i) devices having A.TR Certificate, ii) personal belongings and iii) sample devices. Therefore, apart from these three exceptions TAREKS prior permission must be sought for all medical devices that are indicated in the Appendix 1 of the Communiqué.
It is deserved to provide some more information about TAREKS' prior permission requirement. The importer must upload all the relevant information about the medical device such as the origin, type, trademark, pattern, amount and price of the medical devices, identification of manufacturer/ importer, the name of exporter country, destinations customs into the TAREKS database. After a kind of initial analysis if TAREKS concludes that a full analysis is not necessary, it may provide the permission and provide a reference number for the importation. On the other hand, if after the initial analysis TAREKS decides that an actual inspection is required, the importer must upload within two days after the application date the following documents into the TAREKS database;
- One or more of the custom documents identified below:
- Summary declaration or Bill of lading (Consignment, CMR Document)
- Warehouse declaration
- Free trade zone activity form
- Copy of invoice or proforma invoice (the original invoices need to be presented in order to obtain a certified copy)
- Instruction manuals in Turkish
- EU Declaration of Conformity - (if the declaration is in an EU language other than English, a certified Turkish translation is also required along with the declaration).
Upon the assessment, if TAREKS decides that the medical device does not conform with the general safety and performance requirements and other legal requirements of the Regulations, such as quality and risk management, the importation permission shall not be granted by the TAREKS. On the other hand, if the products meet such conformity standards, the importer granted with the permission, which is the reference number to be declared to customs office in the instance of customs clearance stage.
No- permission requirement for importation of Medical Devices Not Listed in the Communiqué
For the medical devices not mentioned in the Appendix 1 of Communiqué, there is no prior permission process. So the importer only follows the general customs clearance procedure to import the medical device into Turkey.
To conclude, the rise of patient need for the medical devices has increased the medical device related investment in Turkey. Simultaneously, the medical device has become even more important in the health care sector, because innovative medical devices and procedures can considerably improve diagnostics and shorten therapeutic cycles. Due to the safety reasons as implemented by the Ministry of Health the control mechanisms are increased on the medical devices during the import process. In this regard, medical devices manufacturers and suppliers should consult lawyers and customs expert regarding the requirements and conditions for the importation of the medical devices into Turkey.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.