Executive Summary
Total market demand in France for medical equipment was estimated at $ 42.7 billion USD in 2021, with imports accounting for $16.8 billion USD. Imports from the United States were forecasted at $ 5.2 billion USD, or 31.8% of total imports. This percentage is expected to remain approximately the same over the next two years, with overall demand growing at 3% annually.
France ranks among the top five largest medical device markets in the world. France spends 3% of its total health expenditure on medical equipment and supplies, and 0.3% of its GDP, which is average for a Western European country. The overall market is generally well developed; however, certain sub-sectors in the more innovative forms of technology still present opportunities for entry. While the public sector is the largest purchaser of diagnostic, therapeutic and surgical equipment, the private sector is also a very dynamic player.
The continuing deficit of the national health insurance funds have prompted new measures to control spending on medical devices, similar to those already in force for pharmaceuticals.
The Covid 19 pandemic has seriously increased market demand for telemedicine applications and services. The French Social Security does reimburse virtual visits (Teleconsultations) to a General Practitioner. During the height of the Covid 19 pandemic non-Covid related medical procedures have been postponed, but the situation is gradually returning back to normal.
Market Entry
To export medical devices to France, U.S. companies should either have a local agent/distributor or set up a subsidiary. Medical devices in the French market, whether imported products or domestically manufactured lines, are subject to the following requirements:
- Medical devices are required to obtain the CE mark.
- Medical devices are required to have French-language directions for use included.
Current Market Trends
The medical market is likely to only see moderate growth, as it has risen at a very small, steady rate in previous years. The medical manufacturing industry has seen the entry of foreign companies; larger manufacturers are now subsidiaries of multinational groups.
Domestic production in several sectors of the French medical device market is meeting part of the demand, and is supplemented by imports, which now account for around 35% of consumption.
Market Size
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Healthcare Spending (including investment)
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$209,2 billion (2020)
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…as percent of GDP
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11 %
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…of which spent on inpatient services (including long-term care)
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71.5%
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…of which spent on pharmaceuticals/consumables
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22.5%
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…of which spent on investments
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3.8%
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|
…of which spent on outpatient services
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2.2%
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Hospitals, Procedures, Healthcare Professionals UN:
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Number of hospitals -
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2,983
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Public
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1,342
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Private
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1,641
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Number of hospital beds
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320,129
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available beds per capita (1,000)
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5.7
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of which in general hospitals
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217,688
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of which in specialized clinics and rehabilitation centers (2017)
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102,441
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Number of surgical procedures
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8,5 million
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… cataract surgery performed
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1,029,214
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…herniated disk surgery performed
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34,517
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Physicians
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3.4/1,000 people
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|
…of which surgeons are
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3,387
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of which internists
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2,561
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of which pediatricians
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359
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Demographics
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Population
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67,390,625
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Life expectancy men/women
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Male: 79.9 years
Female: 86.2 years
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Infant mortality
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Total: 3.7/1,000
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Percent of population older than 65
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-19.62%
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|
…projection, 2030
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23.3%
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Annual deaths
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9.2/1,000
|
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caused by cancer (rounded number)
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162,700
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caused by circulatory diseases (rounded number)
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154,800
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Prevalence of nervous system and sense organ diseases
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1/3 of the population
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Main Competitors
U.S. companies can expect to face competition in this market from major global suppliers such as Siemens, Fresenius, Hitachi, Toshiba, Philips, and Smith & Nephew. Additionally, competition can be expected from French players such as Air Liquide, Asklé Santé, Coloplast, Landanger, Mediprema, Moria, Paul Hartmann, Peters Surgical, Proteor, Systam, Thuasne. France is home to many subsidiaries of American companies such as Abbott Vascular, Alcon, BD, Boston Scientific, 3M Santé, Baxter, Edwards Lifesciences, GE Medical, Johnson & Johnson Ethicon, Medtronic, St. Jude Medical and Zimmer.
Current Demand
1. Diagnostic Equipment:
The diagnostic sub-sector represents 34% of the total medical equipment market. State-of-the-art diagnostic medical imaging systems are in great demand. Applications for this technology already exist for pediatrics, cardio-vascular care, digestion, urology, and spinal/nerve treatment. As it is well-accepted and effective, the demand for this type of technology will continue to grow. Healthcare professionals are very optimistic about a feature of medical imagery equipment known as “image networking.” This will dramatically improve diagnostics by providing an image data bank that would enable a specialist to compare the image of a current case to hundreds of previous cases.
2. Rehabilitation:
This sub-sector represents 25% of the total medical equipment market. It includes all types of disposable medical products. The increasing elderly population reinforces the demand for all kinds of disposable equipment and supplies such as incontinence products and care kits used by nurses and families for home-care.
3. Surgery:
The surgical instrument and supplies sub-sectors represent approximately 18% of the total sector. Recent developments in the field of non-invasive surgery could have a strong impact on everyday hospital practices. These latest advances offer superior results and also present a significantly reduced risk to patients.
4. Technical aids:
The French market for medical prosthetics, which accounts for about 7% of the total medical equipment market, is characterized by a strong potential for innovative internal prosthetics such as knees, hips, ligaments, and elbows, as well as by a slightly decreasing market for external prosthetics. Technological evolution, especially in the field of anesthesia, offers the potential for rapid changes in this market.
5. Intensive care:
Intensive care equipment sector of medical technology, which includes respiratory monitors, pumps and incubators, represents about 9% of the total medical equipment market. Intensive care equipment follows the latest technological advances. Both public and private hospitals show an increasing demand for intensive care equipment and supplies.
6. Hygiene:
The hygiene sub-sector represents approximately 5% of the total medical equipment sector. Patient and medical personnel safety is of growing concern to both members of the medical profession and the public. Best sales prospects will certainly focus around assuring stringent personnel safety requirements. This is especially due to the concern regarding AIDS and other contagious diseases. In the future, prevention should receive similar emphasis considering the present focus on protection.
Registration Process
All medical devices sold in France must carry the CE Mark. Registering with the French Ministry of Health is addressed on a case-by-case basis. It is in the best interest of any U.S. exporter, and in most cases, this task is handled by the importer/distributor. Indeed, having previous experience with the successful registration of products with the French Ministry of Health will be a critical factor to success in order to facilitate access to end users in France.
Reimbursement
The Ministry of Health publishes an annual list of reimbursed products called the Liste des Produits et Prestations (LPP). This list includes items such as implantable medical devices, bandages, wheelchairs, etc.
In recent years, the French Ministry of Health created the Tarification à l’Activité (T2A) system for hospitals. This is a DRG system through which healthcare providers are reimbursed according to the service they provide to GHM – Groupes Homogènes de Malades (homogeneous group of patients) and GHS – Groupes Homogènes de Séjour (homogeneous group of stay).
Yet it is important to note that this system is currently being reformed.
In France, payment delay for public healthcare institutions has been set by law to a maximum of 50 days.
Barriers
There are no significant barriers on healthcare products in France.
FAQs
1. Is the CE mark enough to export a medical device to France?
No. In order to export a medical device to France, the device, bearing a CE mark, needs to be registered with the French Safety Agency for Health Products : ANSM – Agence Nationale de Sécurité du Médicament et des Produits de Santé — https://ansm.sante.fr/ — e-mail : dajr@ansm.sante.fr. It is a registration not an approval. It is very important that the device is registered otherwise it may not enter the country. The registration can be done either by the manufacturer or the distributor. In any case the device registration is in the name of the manufacturer even if the administrative paperwork is submitted by the distributor.
2. What is the custom import health clearance?
All medical devices entering the French market will be checked at customs, which will issue an import health and safety clearance. To obtain the clearance the following documents are required: Declaration of Conformity, CE certificate, Registration Number from the ANSM, Product labeling (as required in the EU directive): CE marking, authorized representative, Serial number/lot number, Lot numbers: all lot numbers must be reported, preferably on the invoice but if this is not possible, then on the bill of entry.
3. What are the major sales channels in France?
There are two principal sales channels for medical devices served by diverse group of distributors, one for the hospitals/clinics and one for the pharmacies/orthopedic shops. Regarding the expanding online sales channel, French customers are still cautious, despite the increasing use of internet.
U.S. Commercial Service Contact Information
Name: Alain Levy
Position: Commercial Specialist
Email: alain.levy@trade.gov
Phone: +33 (0) 1 43 12 70 14
