The Association of Medical Product Suppliers (AFPM) has presented a 2026 overview of the medical device reimbursement landscape in Romania, covering healthcare financing, market access, reimbursement pathways, public procurement and future policy priorities.
The presentation highlights a system in which medical devices can be funded through multiple mechanisms depending on the healthcare setting, while future reforms are expected to focus increasingly on HTA, value-based procurement, national registries and dedicated reimbursement mechanisms for high-value technologies.
Romania’s Healthcare Financing Model
According to the presentation, Romania has a healthcare system combining public and private financing and provision.
Using Eurostat 2022 data, the document reports:
population of around 19 million;
total healthcare expenditure of approximately 5.8% of GDP;
healthcare expenditure of around €858 per inhabitant;
approximately 77% of total healthcare expenditure funded publicly;
around 23% funded privately.
Hospitals account for the largest share of healthcare expenditure by provider type, representing approximately 45.13%, followed by retailers and other providers of medical goods at 25.55%.
National Health Insurance as the Main Public Payer
Romania’s Social Health Insurance system is a compulsory scheme administered by the National Health Insurance House (NHIH) and its regional offices.
According to AFPM, the system represents approximately 78% of total public health funding.
NHIH acts as the principal national payer and contracts with both public and private healthcare providers, including:
primary care;
outpatient services;
ancillary services;
hospitals;
rehabilitation services.
Role of the Ministry of Health
The Romanian Ministry of Health also contributes to healthcare financing through several mechanisms.
These include:
direct financing of selected public health activities;
National Health Programs;
Priority Actions;
specific funding for areas such as oncology, diabetes, orthopaedics, cardiovascular disease and rare diseases.
National Health Programs can be accessed by both public and private providers, while Priority Actions are focused on specific priorities in public hospitals.
Additional Public Funding Sources
Local and county administrations may provide supplementary funding to healthcare providers they own.
Romania also benefits from:
EU Resilience funding;
EU health funding under the 2021–2027 financial cycle;
other national and European grants.
These funding streams can play an important role in capital investment for medical technologies.
Private Healthcare Funding
Private sources of healthcare funding include:
patient co-payments;
additional patient contributions;
out-of-pocket expenditure;
voluntary health insurance;
health subscription schemes.
The presentation estimates the voluntary health insurance market at more than €100 million and health subscriptions at more than €500 million.
Medical Device Market Access in Romania
Medical device market access in Romania operates within the EU regulatory framework established by:
Regulation (EU) 2017/745 on medical devices;
Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
The presentation references Romanian Government Ordinances 46/2022 and 137/2022 as part of the national implementation framework.
The competent authority identified in the document is ANMDMR — the National Agency for Medicines and Medical Devices of Romania.
Its responsibilities include:
oversight of MDR and IVDR application;
control measures for medical devices;
approval of medical device distributors operating on the Romanian market.
No Formal Medical Device HTA Yet
The presentation states that, at present, Romania does not have a formal HTA system specifically for medical devices.
However, the EU Health Technology Assessment Regulation (EU) 2021/2282 is expected to influence medical device assessment in Romania.
For outpatient laboratory tests and radiology services reimbursed by NHIH, the list of covered services and reimbursement prices is determined by NHIH together with Ministry of Health specialty commissions.
Providers of medical technologies may propose new services for inclusion.
National Health Programs and Priority Actions
The Ministry of Health and NHIH determine which generic services and technologies are included in National Health Programs (NHP) and Priority Actions (AP).
Examples mentioned include:
hip prostheses;
diabetes pumps;
technologies used in oncology;
orthopaedic devices;
cardiovascular technologies.
The presentation notes that NHIH and the Ministry of Health generally do not specify particular brands within these programmes.
Procurement is instead typically carried out at hospital level.
Public Procurement Remains Strongly Price Driven
Medical devices purchased by hospitals through public tenders are governed by Romanian public procurement legislation.
AFPM states that hospital acquisitions are usually based on the lowest price, although legislation allows the use of Value-Based Procurement (VBP).
The presentation notes that VBP remains relatively uncommon.
Example of Value-Based Procurement
AFPM highlights a procurement example involving two national tenders in 2024 and 2025 to equip approximately 2,500 family physician offices.
In these tenders:
price represented only 40% of the evaluation score;
other value criteria represented 60%.
The additional criteria included aspects such as:
training;
warranty;
battery life.
This example is presented as a potential model for broader use of value-based procurement in Romania.
Medical Device Pricing
Unlike pharmaceuticals, medical devices in Romania are generally not subject to a dedicated price-control system.
However, NHIH establishes reference prices for certain devices used in ambulatory or rehabilitation care, including:
hearing aids;
prostheses;
orthoses.
Patients may be required to pay the difference between the reference reimbursement level and the actual device price.
The presentation also notes that access to some technologies may be restricted where clinical guidelines or therapeutic protocols do not yet include them.
Different Reimbursement Mechanisms Across Healthcare Settings
The Romanian reimbursement landscape varies considerably depending on the care setting.
For ancillary outpatient services such as laboratory testing, imaging and nuclear medicine, reimbursement may occur through:
NHIH tariffs;
capital investment.
For hospitals, medical devices, implants, materials and equipment may be funded through:
DRG reimbursement;
day hospitalisation;
National Health Programs;
Priority Actions;
capital investment;
hospital own revenues.
Primary Care, Dialysis and Rehabilitation
For primary and ambulatory care, medical devices may be reimbursed as part of the wider medical service or funded through capital investment.
In dialysis, specific materials and devices may be incorporated into payment per dialysis episode.
For rehabilitation, NHIH maintains reference-price lists for prostheses, orthoses and other devices, with possible patient co-payment.
Emergency Care
Medical devices used in emergency care may be funded through:
operational expenditure;
Priority Actions for areas such as trauma, heart attack and stroke;
capital investment.
The range of reimbursement mechanisms illustrates how market access strategy may vary substantially by product type and clinical setting.
EU HTA Regulation Identified as a Future Priority
One of the main future directions highlighted by AFPM is the implementation of the EU HTA Regulation for medical devices.
The presentation also references the possible use of Managed Entry Agreements for medical technologies following further localisation of the EU HTA framework.
This could represent a significant shift toward more structured evidence-based market access for innovative devices.
Greater Focus on Value-Based Procurement
AFPM also identifies broader adoption of Value-Based Procurement as a future priority.
This would involve greater emphasis on factors beyond acquisition price, potentially including:
clinical value;
total cost of ownership;
training;
service support;
reliability;
lifecycle value.
The presentation also calls for clearer market consultation around medical device procurement.
Public Registry of Medical Devices
Another proposed direction is the development of a public registry covering medical devices in use in Romania.
Such a registry could potentially improve visibility over device utilisation and support healthcare planning, procurement and market monitoring.
Operational Leasing for Public Hospitals
The presentation also raises the possibility of operational leasing models for medical devices in public hospitals.
This could provide an alternative to traditional capital procurement for certain high-cost technologies, although the presentation frames this as a possible future direction rather than an established national policy.
New Reimbursement Mechanisms for High-Value Devices
A particularly relevant development concerns high-value medical technology.
AFPM states that Romania is introducing a specific reimbursement mechanism for high-value medical devices, including technologies such as robotics.
According to the presentation, reimbursement for certain robotic surgery expenditures and equipment maintenance was introduced in 2026 and is in the process of becoming operational.
This could represent an important precedent for future reimbursement models covering advanced medical technologies.
More Regional and National Tenders
Future policy directions may also include greater use of:
national tenders;
regional tenders;
centralised procurement mechanisms.
The presentation specifically references areas such as Romania’s emergency healthcare system.
Broader centralisation could potentially affect supplier strategies, procurement volumes and tender participation requirements.
Public Procurement Reform
AFPM also highlights expected changes linked to the development of a new EU public procurement framework.
The presentation suggests that procurement reform could influence how medical technologies are evaluated and purchased across Romania.
Training hospital procurement staff is also identified as an important priority.
Impact on Medical Device Manufacturers
For medical device manufacturers and suppliers, Romania presents a market in which reimbursement cannot be approached through a single national pathway.
Companies need to understand:
the relevant care setting;
NHIH reimbursement mechanisms;
National Health Programs;
Priority Actions;
hospital procurement;
reference-price systems;
clinical guidelines and protocols;
capital investment programmes.
The appropriate market access strategy may therefore differ considerably between hospital devices, rehabilitation products, diagnostic technologies and high-value capital equipment.
Impact on Market Access Teams
For market access teams, the presentation highlights the growing importance of preparing for a more evidence-driven environment.
Companies should monitor:
implementation of EU HTA requirements;
future national HTA processes for medical devices;
value-based procurement;
Managed Entry Agreements;
new high-value device reimbursement models;
development of national registries;
public procurement reform.
Early evidence planning may become increasingly important as Romania moves toward more structured assessment of innovative medical technologies.
A Reimbursement System in Transition
The 2026 overview shows that Romania’s medical device reimbursement system remains fragmented across multiple financing and procurement channels.
At the same time, several developments point toward a more structured future market access framework.
These include:
implementation of EU HTA;
increased use of value-based procurement;
development of a public device registry;
dedicated reimbursement for high-value technologies;
greater use of national and regional procurement;
stronger procurement expertise.
For manufacturers, the evolution of these mechanisms may create new opportunities but will also increase the importance of clinical evidence, health-economic value and market access planning.
