Country Profile at a Glance

Market Summary

Healthcare Infrastructure

Romania has approximately 460 public hospitals and over 400 private clinics and hospitals. Major public referral centres include Floreasca Emergency Hospital (Bucharest), Victor Babeș Clinical Hospital, and regional university hospitals in Cluj-Napoca, Timișoara, and Iași. Major private hospital groups include Regina Maria (75+ locations), MedLife (over 340 locations), and Medicover — all operating to EU standards and actively expanding. Romania's PNRR (National Recovery and Resilience Plan) includes EUR 2.5 billion for healthcare, driving one of Europe's most significant hospital modernisation programmes.

Market Growth Drivers

• EU PNRR healthcare funding: EUR 2.5 billion for hospital modernisation, new equipment procurement, and digital health infrastructure
• Full CE Mark acceptance: no separate Romanian registration required — CE certified products can be placed on market immediately
• ANMDM efficient market access: Romania's national authority focuses on post-market surveillance, not pre-market re-registration
• Fastest-growing EU medical device market at 9.8% CAGR
• Private hospital sector expansion: Regina Maria, MedLife, and Medicover actively investing in new facilities and equipment
• Romanian diaspora healthcare quality expectations: returning Romanians from Western Europe raising quality standards in private sector procurement

Top Product Categories

Regulatory Framework

As a full EU member state, Romania follows EU MDR directly. CE-marked devices can be placed on the Romanian market without any separate national registration. ANMDM is the national competent authority responsible for post-market surveillance, serious incident reporting, and market surveillance. Economic Operators must register in EUDAMED. Romanian language labelling is required for devices sold in Romania. An EU Authorised Representative is required for most non-EU manufacturers, but not for those established in Türkiye, which are treated like EU manufacturers under the Customs Union (TİTCK notice of 19 September 2023).

• CE Mark (EU MDR 2017/745) required — no separate Romanian registration
• No EU Authorised Representative needed for manufacturers established in Türkiye (Customs Union)
• EUDAMED economic operator registration mandatory
• Romanian language labelling required (IFU must be in Romanian)
• Import duty: 0% (EU Customs Union — Turkey benefits from EU-Turkey Customs Union for industrial products)
• VAT: 21% (standard Romanian VAT rate since 1 August 2025)

Trade & Import Overview

Romania imports medical devices from Germany, USA, France, Italy, and Hungary. German and US suppliers dominate high-technology imaging and monitoring. Turkish exports (EUR 22M) are concentrated in surgical instruments, hospital furniture, and disposables — product categories where Turkey has proven quality and competitive pricing. Romania's EU-Turkey Customs Union membership means zero import duties for Turkish industrial products, including medical devices. Bucharest-based distributors often serve the broader Balkan and Southeast European market from a single operational base.

Opportunities for Turkish Exporters

• Zero import duties: EU-Turkey Customs Union gives Turkish medical device manufacturers a structural cost advantage over non-EU, non-Turkish competing countries in the Romanian market
• PNRR hospital modernisation: EUR 2.5 billion in EU-funded hospital investment is the largest near-term procurement opportunity in Eastern Europe — Turkish hospital furniture, beds, and surgical instrument manufacturers are ideally positioned
• Private hospital growth: Regina Maria and MedLife's aggressive expansion programmes require equipment for 20+ new facilities annually
• Balkan gateway: Bucharest-based distributors routinely cover Bulgaria, Moldova, and sometimes Serbia from the same operation — efficient multi-country Balkan coverage
• EUR 22M existing base: Romania is already one of Turkey's strongest EU medical device export markets — this is relationship deepening and category expansion, not cold entry

Key Challenges

• Romanian language labelling: all IFU must be in Romanian — translation is a cost that must be factored into launch planning
• EU MDR technical documentation: ANMDM post-market surveillance is increasingly active — full EU MDR compliance documentation is mandatory
• Competition from EU suppliers: German, French, and Italian manufacturers have strong local distributor relationships and brand recognition
• PNRR procurement competition: the scale of PNRR tenders attracts major international suppliers; Turkish manufacturers should target specific product categories where they have clear competitive advantage

Strategic Conclusion