Cyprus Medical Device Regulation

“Comprehensive Guide to Cyprus Medical Device Regulations: CYMDA, EUMDR, and Market Entry Strategies”

Updated on 23/01/24
Regulatory Authority: Department of Medical and Public Health Services, Cyprus Medical Devices Authority (CYMDA)
Link for Regulatory Authority:https://www.moh.gov.cy/moh/mphs/mphs.nsf/All/A82FE3D75F4BF2CAC225850A0036075A?OpenDocument
 Local Regulation:EU MDR
Classification:Class I, IIa, IIb, III
 Listing or Registration Requirements:

• Notification to CyMDA via email ([email protected]) including notification file.
• Registration is mandatory only for Manufacturers/Authorized Representatives having their place of business in Cyprus.
• Documents Required for Registration:Like list of Documents required in EU.
  • List of documents
  1. A general description of the product, including any variants planned and its intended use(s)
  2. Design drawings, methods of manufacture envisaged and diagrams of components, sub-assemblies, circuits
  3. The descriptions and explanations necessary to understand the above-mentioned drawings and diagrams and the operations of the product
  4. Results of the risk analysis and a list of the harmonized standards, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements
  5. In the case of products placed on the market in a sterile condition, description of the methods used and the validation report
  6. The results of the design calculations and of the inspections carried out
  7. The solutions adopted to ensure that the design and construction conform to safety principles
  8. The pre-clinical evaluation
  9. The clinical evaluation in accordance with Annex X
  10. The label and instructions for use

Registration Timeline:

• Class I: 4 –6 weeks
• For the other classes, it depends on the contract with the notified body and the type of device.

License Validity:5 Years

Special Labelling Requirements:

• For Medical Devices or In Vitro Medical devices which are meant to be used only by healthcare professionals English or Greek languages are acceptable.
• For Medical Devices or In Vitro Medical devices which are meant to be used by lay person Greek language is compulsory

 Who should make this communication:

When to make this communication: Before placing a medical device into the market.

Barriers: Cyprus imposes no import restrictions, welcoming products that align with EU regulations. The import environment is receptive to innovative, high-quality equipment, fostering an open market for diverse goods.

Market entry: As a member of the EU, the Republic of Cyprus aligns its medical device legislation with key EU directives, including active implantable medical devices 90/385/EEC, medical devices 93/42/EEC, and in-vitro medical devices 98/79/EC, along with supplemental directives. Trade in medical products is duty-free within the EU, and non-EU manufacturers must designate an EU-based authorized representative unless they have a registered EU business. The representative serves as the contact point for Cypriot authorities, handling administrative tasks or functioning as an importer/distributor. Products for use in Cyprus should bear the “Conformité Européene” (CE) mark, signifying compliance with EU directives. A correctly CE-marked device requires no additional approval for EU-wide marketing. Additional requirements may apply based on the medical product, particularly regarding device information language

Additional information: On April 5, 2017, two new regulations governing medical devices were adopted, coming into effect on May 25, 2017, and replacing the existing directives. However, these regulations would only become applicable following a designated transitional period. Specifically, the Regulation on medical devices would take effect three years after its entry into force in spring 2020, while the Regulation on in vitro diagnostic medical devices would be applicable five years after entry into force in spring 2022.

For products that are already registered in a European country, bear the CE mark, and are accompanied by all the relevant certificates, it is mandatory that all such products intended for placement on the Cypriot Market must undergo notification to the Cyprus Medical Devices Competent Authority.

How OMC Medical can assist you with the process

• Act as your Authorized representative

Why Choose Us

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: [email protected]