Cyprus medical device registration timeline
Source-linked clocksΑρμόδια Αρχή Ιατροτεχνολογικού Εξοπλισμού (CYMDA), Medical Services and Public Health Services, Ministry of Health (Ministry of Health) review clocks and end-to-end planning ranges, using the 4-class (I, IIa, IIb, III) — EU MDR classification system.
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| Class I(Self-declaration (no notified body)) MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so neither the CYMDA nor a notified body reviews the file and there is no review clock Elapsed time is EUDAMED actor and device registration, mandatory since 28 May 2026 and carrying no guaranteed processing time, plus the Cypriot notification duty under Decree No. 7, for which the CYMDA publishes no period | 0 days | 6-9 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesPlanning steps and estimates; these are not regulator deadlines.
Cyprus Medical Device Registration Process
Step-by-step Ministry of Health registration process. Total estimated timeline: 6-9 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by Ministry of Health. Appoint a EU Authorized Representative.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to Ministry of Health including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksMinistry of Health reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
0 daysIn-depth technical assessment of device safety and performance. Ministry of Health may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, Ministry of Health issues Cyprus market authorization certificate.
- EU Authorized Representative (for non-EU manufacturers)
- Notification of the medical devices an operator places on or makes available on the Cypriot market to the CYMDA, by sending the CYMDA spreadsheet to cymda@mphs.moh.gov.cy; the duty derives from Decree No. 7 published in Part II of the Third Supplement of the Official Gazette of 5 January 2012 and is restated in the CYMDA notice of 6 November 2025
- The notification is per economic operator and not per product: the CYMDA states that one economic operator's notification of a device is independent of another economic operator's notification of the same device
- Importer details — name, registered trade name or trade mark, registered place of business and address — on the device, its packaging or an accompanying document, without covering any of the manufacturer's markings (MDR Annex I §23.2 / IVDR Annex I §20.2)
- Information for safe and proper use in English and/or Greek, and necessarily also in Greek for products intended for use by non-healthcare professionals (Decree No. 6 under article 59(1)(ζ) of the Basic Requirements Laws 2002 to 2011); the instructions for use must also meet the requirements of Regulations (EU) 2017/745 and 2017/746
- Distributors must verify a device's conformity and the presence of the importer details before making it available, and must keep storage and transport conditions within the manufacturer's terms
- EUDAMED actor registration (MDR Art. 31(1) / IVDR Art. 28(1)) and device registration in the UDI database (MDR Arts. 28-29 / IVDR Arts. 25-26), compulsory since 28 May 2026 under Commission Decision (EU) 2025/2371
- A clinical investigation or performance study requires authorisation from the CYMDA, which is granted where the Cyprus National Bioethics Committee has not issued a negative opinion (MDR Arts. 62 and 63 to 80 with Annex XV; IVDR Arts. 56 to 57 and 59 to 77 with Annexes XII and XIV)
- In-vitro diagnostic products are registered with the CYMDA on the separate 'Registration for IVD products' form rather than on the medical-device notification spreadsheet
- Non-compliant devices may attract administrative measures and/or fines under Law 225(I)/2022 on market surveillance
Reviewed 2026-09-16. End-to-end totals remain planning estimates.