General country-specific regulatory information is provided on this page. Become a LICENSALE.COM
user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application.
Devices are regulated by the EU list of Competent Authorities. In Cyprus, devices are regulated by the Department of Medical and Public Health Services under the Ministry of Health.
Medical devices are classified according to risk into Classes I, IIa, IIb and III.
The EU registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.
Licenses issued in the EU are valid for five years.
An authorized representative is required anywhere in the European Union.
On April 5, 2017, two new Regulations on medical devices were adopted, these entered into force on May 25, 2017 and replaced the existing Directives. The new rules will only apply after a transitional period, namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.
For products that are already registered in a European Country, bear the CE mark and are accompanied by all the relevant certificates, there is no further registration process to place them in the Cypriot market. However, following decree number 7, published in the Cyprus Government Gazette on the 5th of January 2012 (Issue 4462, Annex III, part II), information concerning the medical devices are to be submitted electronically to the Cyprus Medical Devices Competent Authority.
Last updated on October 19, 2018.
Interested in obtaining fast market approval for your medical device or IVD in the EU? REQUEST A FREE QUOTE>
For more information on registration in the EU, check out the following articles on our blog:
5 Questions and Answers: Additional Regulations in the EU
4 Steps to Comply With EU Directive RoHS 2