Product approval
A certificate or approval attached to the finished product, component, or radio host.
Free · No signup · Official source linksCyprus medical device certification and licence checker
Check Cyprus requirements beyond medical-device classification, including radio, electrical, metrology, radiation, import, environmental, and product-specific routes.
7 maintained routes16 official source links
Preliminary applicability · country-specific scope
What you receive
Not just a yes or no
A route-by-route answer. Separate product certificates, dossier evidence, import documents, and facility licences stay separate.
Trigger reasoning. See which product facts matter and which missing facts prevent a reliable conclusion.
Official starting points. Open the regulator or government sources behind the maintained country matrix.
How to read the answer
Classification is only the first layer
A device may have one medical risk class and still trigger separate radio, electrical, measurement, radiation, environmental, import, or installation requirements. The checker keeps each regulatory object separate.
Dossier or import evidence
Testing can belong inside the medical dossier, while some documents apply to each shipment.
Site or operator licence
Radiation, installation, use, or measurement controls may apply to a facility or operator.
Country-specific scope
Medical device certification routes in Cyprus
Electrical safety
Medical electrical equipment outside the Low Voltage Directive
Evidence is normally handled inside the medical-device registration route.
Source association awaiting review
EMC
EMC Directive switched off by the more specific MDR essential requirements
Evidence is normally handled inside the medical-device registration route.
Source association awaiting review
Wireless / radio
Radio Communications (Radio Equipment) Regulations Κ.Δ.Π. 310/2016, as amended
Applies when the product, feature, component, or use is in scope.
Source association reviewed
Environmental / battery
Department of Environment extended producer responsibility for WEEE and batteries
Maintained as a mandatory pre-market route.
Source association reviewed
Metrology
Weights and Measures Service — legal metrology authority
Applies to the facility, operator, or installation rather than only the product.
Source association reviewed
Radiation
Department of Labour Inspection — ionizing radiation protection and nuclear safety
Applies to the facility, operator, or installation rather than only the product.
Source association reviewed
Laser / UV / ultrasound
Department of Labour Inspection — non-ionizing radiation in the working environment
Applies to the facility, operator, or installation rather than only the product.
Source association reviewed
Official starting points
Use these authority pages to confirm current scope, technical rules, application routes, and transition dates. A linked source does not turn a preliminary result into an authority decision.
Αρμόδια Αρχή Ιατροτεχνολογικού Εξοπλισμού (CYMDA), Ministry of Health
Notification of medical devices placed on the Cypriot market — CYMDA spreadsheet filed to cymda@mphs.moh.gov.cy
Αρμόδια Αρχή Ιατροτεχνολογικού Εξοπλισμού (CYMDA), Ministry of Health
Decree No. 6 language requirements for medical and in-vitro diagnostic devices — English and/or Greek, Greek compulsory for use by non-healthcare professionals, enforced under Law 225(I)/2022
Αρμόδια Αρχή Ιατροτεχνολογικού Εξοπλισμού (CYMDA), Ministry of Health
Notice of 6 November 2025 on recording the importer's details on medical devices and other distributor and importer duties — restates Decree No. 7 of the Official Gazette of 5 January 2012
Αρμόδια Αρχή Ιατροτεχνολογικού Εξοπλισμού (CYMDA), Ministry of Health
Notice of 8 January 2026 — compulsory use of the first four EUDAMED modules from 28 May 2026 under Commission Decision (EU) 2025/2371
Αρμόδια Αρχή Ιατροτεχνολογικού Εξοπλισμού (CYMDA), Ministry of Health
Definitions and classification of medical devices — MDR Article 2(1) adopted as the Cypriot definition
Αρμόδια Αρχή Ιατροτεχνολογικού Εξοπλισμού (CYMDA), Ministry of Health
Commencement of a clinical investigation or performance study in Cyprus — CYMDA authorisation and the National Bioethics Committee opinion
Αρμόδια Αρχή Ιατροτεχνολογικού Εξοπλισμού (CYMDA), Ministry of Health
Registration for IVD products — CYMDA application form
EUR-Lex
Low Voltage Directive 2014/35/EU Annex II — electrical equipment for radiology and medical purposes outside scope
EUR-Lex
EMC Directive 2014/30/EU Article 2(3) — more specific Union legislation displaces the directive
EUR-Lex
Regulation (EU) 2017/745 (MDR) — Annex I electrical-safety and electromagnetic-compatibility essential requirements
Τμήμα Ηλεκτρομηχανολογικών Υπηρεσιών (Electrical and Mechanical Services Department), Ministry of Transport, Communications and Works
Electromagnetic Compatibility Regulations Κ.Δ.Π. 181/2017 and Κ.Δ.Π. 589/2020
Τμήμα Ηλεκτρονικών Επικοινωνιών (Department of Electronic Communications), Deputy Ministry of Research, Innovation and Digital Policy
Radio Communications (Radio Equipment) Regulations — basic regulation Κ.Δ.Π. 310/2016 with the first amendment Κ.Δ.Π. 231/2026
Τμήμα Ηλεκτρονικών Επικοινωνιών (Department of Electronic Communications), Deputy Ministry of Research, Innovation and Digital Policy
Radio Communications (Radio Equipment) (Basic) Regulations of 2016, Κ.Δ.Π. 310/2016, Official Gazette No. 2154 of 4 November 2016
Τμήμα Περιβάλλοντος (Department of Environment), Ministry of Agriculture, Rural Development and Environment
Extended producer responsibility for packaging, WEEE, batteries and accumulators, and tyres — permits signed by the Minister; WEEE Regulations Κ.Δ.Π. 73/2015; register of producers of batteries and accumulators
Υπηρεσία Μέτρων και Σταθμών (Weights and Measures Service), Ministry of Energy, Commerce and Industry
Competent authority for the Weights and Measures legislation — verification of weighbridges and scales and reference testing of prepacked goods
Τμήμα Επιθεώρησης Εργασίας (Department of Labour Inspection), Ministry of Labour and Social Insurance
Ionizing radiation protection and nuclear safety, and non-ionizing radiation in the working environment
About this checker
A preliminary tool, not a regulatory determination
Describe the complete product — radio, power, measurement, radiation, battery, materials, accessories, intended use, import route, and existing approvals. The free checker maps those facts to the maintained Cyprus scheme matrix and links each route to its maintained source associations, with reviewed, candidate and unresolved states shown separately.
Use the result to identify questions and official sources. Final scope can depend on exact models, modules, bands, components, claims, HS codes, import structure, installation site, and current authority interpretation.
- Is this the same as medical device classification in Cyprus?
- No. Risk classification determines the main medical-device pathway. This checker runs after classification and looks for additional product certificates, dossier evidence, import documents, and facility or operator licences.
- Does “no separate certificate” mean no testing is required?
- No. Safety, EMC, performance, or other evidence can still be required inside the medical-device dossier even when there is no separate national product certificate.
- Is the result an official regulatory determination?
- No. It is a preliminary applicability assessment. Review the linked official source and confirm the final route with the relevant authority, certification body, importer, or regulatory professional.
DJ Fang
MedTech Regulatory Expert
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