The Turkish Medicines and Medical Devices Agency (TİTCK) published two new drafts on its website as a part of the harmonization process with the EU medical devices standards.
One of the drafts, the “Regulation Amending Regulation on In Vitro Diagnostic Medical Devices,” expands the list of high-risk in vitro diagnostic medical devices. The new draft conforms to the EU Directive 2011/100/EU amending Directive 98/79/EC.
The other draft replaces Communiqué No. 2005/1, primarily supplying several new terms and definitions, as well as general principles for common technical specifications. Utilizing the same title as the previous document, “Communiqué on Common Technical Features for In Vıtro Diagnostic Medical Devices,” the new draft adopts the EU Commission decisions 2009/886/EC and 2011/869/EU. The Commission’s decisions addressed public health and technical progress.
The TİTCK receives public opinion until 5 p.m. on August 29, 2016, through email@example.com.
For years the TİTCK has demonstrated its commitment to harmonizing the healthcare sector in Turkey with EU standards. The publication of this draft reiterates the TİTCK’s intention to continue its harmonization efforts.