Medical Devices Regulatory Framework & Update: Turkey (September 2021)

36 pages. The Turkey medical device market and regulatory framework are regulated by the Turkish Medicines and Medical Devices Agency (TMMDA) and the Turkish Ministry of Health (MoH). As part of Turkey's first Health Transformation Program from 2003 until 2013, the MoH has conducted a comprehensive assessment and concluded that Turkey should follow the example paved by many developed and developing countries when it comes to handling regulatory and inspections functions. Thus, the TMMDA has coordinated the medical devices regulations in Turkey to be regulated based on European Council Directives with the latest revision following the Medical Device Regulation (EU) 2017/745. Understanding the revised regulations is essential for medical device manufacturers to be aware of the significant impact these changes will have on the global medical device market. Although the new regulations and guidance documents provide more structure to the application process in Turkey, however, the process for gaining access to the market can be lengthy and complex. Navigating the process can be intimidating and requires planning with experienced regulators.