Healthcare Technologies Resource Guide - Export.gov

Medical devices in the French market, whether\ for imported products or domestically manufactured
lines, are subject to the following requirements:
• Medical devices have to obtain the CE mark.
• Medical devices have to have Directions for use enclosed in the French.
Current Market Trends
The medical market is likely to see moderate growth, rising from USD 6.784 billion in 2012 to USD 7.8
billion by 2017. Foreign companies are prominent in the domestic medical manufacturing industry,
with larger manufacturers operating as subsidiaries of multinational groups. With flagging domestic
production in several sectors the French medical device market is increasingly reliant upon imports,
which now account for around 50% of consumption.
Main Competitors
France is home to many subsidiaries of American companies such as Alcon, 3M, Baxter, Johnson &
Johnson medical, Medtronic, Boston Scientific, Cyberonics and St. Jude Medical.
Current Demand
• Diagnosis: The diagnostic sub-sector represents 35 percent 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. Health care 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 26 percent 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 surgery instrument and supplies sub-sectors represent approximately 17 percent of
the total sector. Recent developments in the non-invasive surgery field could have a strong impact
on everyday hospital practice. These latest advances offer superior results and also present a
significantly reduced risk to patients.
• Technical aids: The French market for medical prosthesis, 8 percent of the total medical equipment
market, is characterized by a strong potential for innovative internal prosthesis such as knees, hips,
ligaments, and elbows, and with a slightly decreasing market for external prosthesis. Technological
evolution, especially in the field of anesthesia, offers the potential for rapid changes in this market.
• Intensive care: Intensive care equipment such as respiratory monitoring, pumps and incubators
represent about 8 percent of the total medical equipment market. Intensive care equipment includes
the latest technological advances. Both public and private hospitals show a rising demand for
intensive care equipment and supplies.
• Hygiene: The hygiene sub-sector represents approximately 6 percent of the total medical
equipment sector. Patient and medical personnel safety is of growing concern to 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 requirements considering the current
concerns regarding infectious diseases. In the future, prevention should receive similar emphasis
considering the present focus on protection.
Registration Process
All medical devices sold in France have to carry the CE Mark. Registering with the French Ministry of
Health is to be addressed on a case by case basis. In the very best interest of any U.S. exporter, and in the
vast majority of cases, this task is handled by the importer/distributor.
U.S. Commercial Service Healthcare Technologies Resource Guide | 2012–2013
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