Medical Device Registration and Approval in Cyprus
General country-specific regulatory information is provided on this page for medical device registration and approval in Cyprus. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Cyprus, to expedite the preparation of your medical device or IVD registration application.
Medical Device Regulations and Classification in Cyprus
REGULATORY AUTHORITY: 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.
CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb and III.
TIMEFRAME: 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.
LICENSE VALIDITY: Licenses issued in the EU are valid for five years.
AUTHORIZED REPRESENTATIVE: An authorized representative is required anywhere in the European Union.
ADDITIONAL INFORMATION: 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.
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