Healthcare Resource Guide: France

 

France

Statistics

Summary
Market Entry

Current Market Trends

Main Competitors

Current Demand


Registration Process
Reimbursement

Barriers

Trade Events

CS Contact

Market Size

Capital: Paris

Population: 67.2 Million (2017)
GDP:
US $2.58 Trillion (2017)
Currency:
Euro (€)
Language
: French

Summary

Total market demand in France for medical equipment was estimated at USD 39.1 billion in 2018, with imports accounting for USD 13.6 billion. Imports from the United States were forecasted at USD 4.4 billion, or 33.5% of total imports. This percentage is expected to remain approximately the same over the next two years, with overall demand growing at 3% annually.

 

2016

2017

2018 (estimated)

Total Market Size

35.4

37

39.1

Total Local Production

32.1

33.5

35.6

Total Exports

9.2

9.6

10.1

Total Imports

12.5

13.1

13.6

Imports From the U.S.

4.2

4.4

4.6

Exchange Rate:

1 EURO =

1.1069 USD

1.0628 USD

1.1681 USD

France ranks among the top five largest medical device markets in the world. France spends 3% of 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 has prompted new measures to control spending on medical devices, similar to those already in force for pharmaceuticals.

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 past years. The medical manufacturing industry has seen 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.

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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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 the vast majority of 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 2007, 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.

Procurement & Tenders

Hospital Procurement Executives have created a professional network: RESAH – Réseau des Acheteurs Hospitaliers – www.resah.fr

Tenders for the hospital sector can be found on several web sites, four of which are:

Trade Events

PARIS HEALTHCARE WEEK

May 21-23, 2019

PARIS / Porte de Versailles

http://www.parishealthcareweek.com

FAQs

  • 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.

  • 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 need to be reported, preferably on the invoice but if this is not possible on the bill of entry.

  • 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

Market Size

Healthcare spending (including investment)

$227.8 billion (2017)

...as percent of GDP

11.1 % (2017)

...of which spent on inpatient services (including long-term care)

73.2% (2017)

...of which spent on pharmaceuticals/consumables

26.9% (2016)

...of which spent on investments

3.2%

...of which spent on outpatient services

2.6 % (2017)

Hospitals, Procedures, Healthcare Professionals UN:

Number of hospitals

3,089 (Feb 2017)

…Public

1,389

…Private

1,700

Number of hospital beds

408,245 (2017)

…available beds per capita (1,000)

6.1

…of which in general hospitals

253,367 (2017)

…of which in specialized clinics and rehabilitation centers

154,881 (2017)

Number of surgical procedures

17,560 (2017)

...cataract surgery performed

600,000 people in the population (2015)

...herniated disk surgery performed

30,000 people in the population (2015)

Physicians

3.4/1,000 people (2016)

...of which surgeons

59.27/100,000 (2017)

…of which internists

2,500 (2017)

…of which pediatricians

7,861 (2017)

Dentists

42,000 (2017)

Demographics

Population

67,186,640

Life expectancy men/women

Male: 78.8 years

Female: 85.2 years

Infant mortality

Total: 3.2/1,000

Percent of population older than 65

(-)19.82%

...projection, 2030

23.2%

Annual deaths

8.4/1,000

…caused by cancer (rounded number)

150,000 (2016)

…caused by circulatory diseases (rounded number)

130,000 (2016)

Prevalence of nervous system and sense organ diseases

caused 36,000 deaths in 2015 which was double from 1998


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